Video Abstract

Video Abstract

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The authors of this study evaluated infant and parent outcomes at 12 and 24 months after a clinician-supported, web-based early intervention for preterm infants.

OBJECTIVE

To examine the efficacy of a clinician-supported, web-based intervention delivered over the first year after birth compared with standard care in children born after <34 weeks’ gestation, on child development at 24 months corrected age (CA), parental mental health, and the parent-child relationship at 24 months.

METHODS

We randomly allocated 103 preterm infants to clinician-supported, web-based intervention (n = 50) or standard care control (n = 53) groups. At 24 months CA, child cognitive, language, motor, social–emotional development, and the parent–child relationship were assessed. Parental mental health and quality of life were assessed at 12 and 24 months CA.

RESULTS

At 24 months, child development, maternal mental health, and maternal quality of life were similar for the intervention and control groups. There was some evidence that mothers in the intervention group had lower odds of being in the elevated category for depression at 12 months (odds ratio: 0.19; 95% confidence interval [CI]: 0.04–0.90; P = .04). Scores were higher in the intervention group for child responsiveness (mean difference: 0.57; 95% CI: 0.03–1.11; P = .04), child involvement (mean difference: 0.61; 95% CI: 0.09–1.13; P = .02), and maternal structuring (mean difference: 0.72; 95% CI: 0.22–1.21; P = .01) during the parent–infant interaction at 24 months.

CONCLUSIONS

This study provides preliminary evidence that a clinician-supported, web-based early intervention program for preterm infants had a positive effect on the parent–child relationship and maternal mental health immediately after the intervention but potentially little effect on child development.

WHAT’S KNOWN ON THIS SUBJECT:

Early intervention programs for children born preterm and their parents provide benefits to child cognitive and social–emotional development and parental mental health. However, whether web-based early interventions are effective for this population is unclear.

WHAT THIS STUDY ADDS:

This randomized trial provides preliminary evidence that a clinician-supported, web-based early intervention program for parents after preterm birth is associated with selective benefits to maternal mental health at 12 months and the parent–child relationship at 24 months.

Preterm birth (birth <37 weeks’ gestation) increases the risk of impairments in cognitive, neurosensory, motor, and social–emotional functioning compared with term-born peers.13  Preterm birth also increases the risks to parental mental health including depression, anxiety, and posttraumatic stress symptoms.47  Early intervention programs for preterm children that begin while infants are in the NICU or early postdischarge have positive effects on child cognitive development8,9  and child behavioral outcomes.10  Programs that actively support and involve parents have been associated with benefits for parental anxiety, depression,11,12  and the parent–child relationship.13  Moreover, early intervention that focuses on the parent–child relationship rather than child development or parental support alone has larger effects on cognitive outcomes.8 

We previously reported improved parental mental health and child social–emotional functioning after a home-based preventive care intervention for preterm children over the first year after birth but no measurable gain in child development overall.12,14  Given the impact that preterm birth can have on cognitive development, more effective interventions are needed. However, home-visiting interventions are costly, labor-intensive, challenging to deliver to nonmetropolitan families, and, thus, difficult to implement into clinical practice. Given that web-based interventions can improve accessibility15  and have evidence for efficacy in improving mental health16  and child outcomes in families with social disadvantage,17  we adapted the features of our preventative care intervention into a clinician-supported (ie, psychologist, allied health), web-based intervention.

The primary aim of this randomized controlled trial was to assess the effectiveness of a clinician-supported web-based intervention called “e-prem” delivered over the first year after birth, compared with standard care, on cognitive development at 24 months corrected age (CA) in children born <34 weeks’ gestation. Secondary outcomes were child language, motor, and social–emotional development, the parent–child relationship at 24 months, and parental mental health and quality of life at 12 and 24 months. It was hypothesized that the intervention would improve child developmental outcomes, parental mental health, and the parent–child relationship.

Infants born <34 weeks’ gestation and their primary caregiver (all mothers) were recruited from the NICU at the Royal Women’s Hospital in Melbourne, Victoria, over 2 years (January 2015 to December 2016). Nonprimary caregivers were also invited to participate. Eligible families were approached within 3 weeks of birth after consultation with the medical team. Exclusion criteria included congenital anomaly known to adversely affect infant development and primary caregivers unable to communicate in English (intervention only available in English). Ethical approval was provided by the Royal Women’s Hospital and Royal Children’s Hospital Human Research Ethics Committees. Parents provided written informed consent.

This was a 2-arm parallel group randomized controlled trial of the e-prem intervention versus standard care, prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR 12614000906651) and is reported according to CONSORT guidelines.

Baseline Data Collection

To assess baseline depression and anxiety symptoms, mothers completed mental health questionnaires before randomization, including the Edinburgh Post-Natal Depression Scale 18  and Generalized Anxiety Disorder-7.19  Family social risk20  was assessed, generated from the sum of the following: maternal age, primary caregiver education and occupation, main income earner occupation and employment, and language spoken at home. Each variable was assigned a score of 0, 1, or 2, with higher scores representing higher social risk. Child neonatal medical data were collected from medical records (Table 1).

TABLE 1

Baseline Characteristics of Participants

Infant and Primary Caregiver CharacteristicsInterventionControl
Infant n = 50 n = 53 
 Birth weight, g, mean (SD) 1317 (322) 1269 (447) 
 Gestational age, wks, mean (SD) 29.2 (2.1) 28.7 (2.2) 
 Multiple at birth, n (%) 19 (38%) 21 (40%) 
 Sex, male, n (%) 31 (62%) 20 (38%) 
 BPD, n (%) 8/48 (17%) 15/49 (31%) 
 Surgery during the primary hospitalization, n (%) 3/47 (6%) 4/51 (8%) 
 Any intraventricular hemorrhage,an (%) 9/44 (20%) 12/51 (24%) 
 Child accessed any intervention service within first 2 y after birth (other than usual GP and follow-up) 22/29 (75%) 22/24 (92%) 
Primary caregiver (mothers) n = 41 n = 42 
 Age, y, mean (SD) 32.2 (4.4) 32.5 (4.0) 
 Education primary caregiver (n; tertiary: secondary: <12 y) 33: 8: 0 29: 11: 2 
 Occupation primary income earner (n; skilled: semiskilled: unskilled) 27: 9: 5 31: 7: 4 
 Employment status primary income earner (n; full-time: part-time: unemployed) 36: 3: 2 37: 2: 3 
 Family structure (n; 2 parents: 1 parent) 39: 2 42: 0 
 English spoken at home (n; English only: English & another: little/no English) 30: 8: 3 35: 7: 0 
 Social risk total, median (interquartile range) 1 (0–2) 1 (0–2) 
 Higher social risk category, n (%) 14/41 (34) 11/42 (26) 
 Depression symptoms score, mean (SD) 7.6 (4.1) 7.4 (5.0) 
 Anxiety symptoms score, mean (SD) 5.6 (3.9) 6.1 (4.8) 
 Mother accessed any intervention service within first 2 y after birth (other than usual GP care), n (%) 13/34 (38) 13/36 (36) 
Infant and Primary Caregiver CharacteristicsInterventionControl
Infant n = 50 n = 53 
 Birth weight, g, mean (SD) 1317 (322) 1269 (447) 
 Gestational age, wks, mean (SD) 29.2 (2.1) 28.7 (2.2) 
 Multiple at birth, n (%) 19 (38%) 21 (40%) 
 Sex, male, n (%) 31 (62%) 20 (38%) 
 BPD, n (%) 8/48 (17%) 15/49 (31%) 
 Surgery during the primary hospitalization, n (%) 3/47 (6%) 4/51 (8%) 
 Any intraventricular hemorrhage,an (%) 9/44 (20%) 12/51 (24%) 
 Child accessed any intervention service within first 2 y after birth (other than usual GP and follow-up) 22/29 (75%) 22/24 (92%) 
Primary caregiver (mothers) n = 41 n = 42 
 Age, y, mean (SD) 32.2 (4.4) 32.5 (4.0) 
 Education primary caregiver (n; tertiary: secondary: <12 y) 33: 8: 0 29: 11: 2 
 Occupation primary income earner (n; skilled: semiskilled: unskilled) 27: 9: 5 31: 7: 4 
 Employment status primary income earner (n; full-time: part-time: unemployed) 36: 3: 2 37: 2: 3 
 Family structure (n; 2 parents: 1 parent) 39: 2 42: 0 
 English spoken at home (n; English only: English & another: little/no English) 30: 8: 3 35: 7: 0 
 Social risk total, median (interquartile range) 1 (0–2) 1 (0–2) 
 Higher social risk category, n (%) 14/41 (34) 11/42 (26) 
 Depression symptoms score, mean (SD) 7.6 (4.1) 7.4 (5.0) 
 Anxiety symptoms score, mean (SD) 5.6 (3.9) 6.1 (4.8) 
 Mother accessed any intervention service within first 2 y after birth (other than usual GP care), n (%) 13/34 (38) 13/36 (36) 

BPD, bronchopulmonary dysplasia, defined as oxygen or ventilator dependence at 36 wk; GP, general practitioner

a

No infant developed cystic periventricular leukomalacia.

Randomization

After the collection of baseline data, families were randomly allocated to the intervention or control (standard care) group in a 1:1 ratio. Because the intervention is delivered to the parent, families rather than infants were the unit of randomization. Random allocation was computer-generated by an independent statistician by using block randomization with variable block sizes, stratified by multiple births (singleton versus multiple). Group allocation was determined by using concealed envelopes. Parents and study coordinators could not be blinded to group allocation because of the nature of the intervention; however, outcome assessors at follow-up were blinded.

Intervention

The intervention group had access to the e-prem Web site and received phone-based clinician support shortly after randomization until their infant was 12 months CA in addition to standard clinical care. The intervention has 8 age-dependent modules (5–10 topics each). E-prem focused on education about preterm infant development, strengthening parent–child relationships, and supporting parental mental health. Parents could access all modules at any time; however, to assist in navigation, the program was automated to change the presentation of new modules as relevant to the infant’s age. All support phone calls were delivered by the same clinician and topics discussed were aligned with the web-based content and addressed issues reported by parents. The first clinician–parent contact occurred face-to-face in the NICU, with subsequent support phone calls weekly for the first month of the program, fortnightly for the second month, and then monthly, or as needed. To maintain the overall fidelity of the intervention design, fortnightly supervision sessions were conducted between principal investigators and clinicians.

The control group received standard clinical care and an information pack at recruitment that included contact details for relevant support services (including public internet sites; e-prem was password protected), and brief publicly available information on infant health and development. Standard care included support from nursing care managers, social workers, and allied health clinicians, as appropriate, while in the hospital. After discharge, standard care included access to maternal child health nurses and clinician-referred early intervention childhood services or mental health services as deemed clinically necessary.

There were 2 follow-up timepoints: immediately postintervention when infants were 12 months CA and at 24 months CA (12 months postintervention).

Primary Outcome

Child cognitive development was assessed at 24 months CA by using the Cognitive Composite Score on the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III).21  Standard scores have a mean of 100 (standard deviation [SD] of 15); higher scores reflect better performance.

Secondary Outcomes: Child Language, Motor, and Social–Emotional

Child language and motor development were assessed at 24 months CA by using the Language and Motor Composite Scores on the Bayley-III. Child social–emotional development at 24 months CA was assessed by using the Infant and Toddler Social-Emotional Assessment,22  a parent-report questionnaire. The Infant and Toddler Social-Emotional Assessment provides standardized continuous scores (mean = 50; SD = 10; range: 25–80) for 4 domains (internalizing behavior, externalizing behavior, dysregulation, and social-emotional competence). Higher scores on the internalizing, externalizing, and dysregulation domains and lower scores on competence represent more challenges.

Secondary Outcome: Parental Mental Health

Parental mental health was assessed at 12 and 24 months CA by using the following measures:

  1. Centre for Epidemiologic Studies Depression Scale23  (measuring symptoms of depression), with a total score range of 0–60 (scores ≥16 are categorized as “elevated”).

  2. Generalized Anxiety Disorder-7 questionnaire,19  with a total score range of 0–21 (scores ≥10 are categorized as “elevated” anxiety).

  3. Posttraumatic checklist, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,24  (assessed at 24 months only); continuous total score range: 17–85, with a higher score indicative of more posttraumatic stress symptoms.

Secondary Outcome: Parental Quality of Life

Parental quality of life was assessed at 12 and 24 months CA by using the Assessment of Quality of Life.25  The Assessment of Quality of Life has 8 domains: independent living, pain, senses, happiness, mental health, coping, relationships, and self-worth. Summed items in each domain form continuous scores; higher scores represent a poorer quality of life.

Secondary Outcome: Parent–Child Relationship

Parent–child relationship was assessed at 24 months CA by using the Emotional Availability Scales (EAS).26  The EAS is an observational measure with 6 domains: adult sensitivity (warmth, perceptiveness, responsiveness to child cues), adult structuring (appropriately guiding and scaffolding child behavior and emotions), adult nonintrusiveness (absence of overly directive or interfering parenting), adult nonhostility (absence of negative affect, hostility, impatience), child responsiveness (positive affect and responsiveness to parent), and child involvement (attending to and involving the parent in the interaction). Scores for each domain range between 1 and 7; higher scores represent more optimal interaction. Dyads were filmed while completing a semistructured play session for 15 minutes, which included a brief pack-up and challenging puzzle at the end. Videos were later coded by 3 trained and EAS-accredited project team members. Interrater and intrarater reliability were adequate (Supplemental Table 6).

Secondary Outcome: Statistical Analysis

Analysis was completed on an intention-to-treat basis according to the families’ random allocation, irrespective of the intervention received using a complete case analysis. For the primary outcome (cognitive development) and secondary child outcomes, the estimand of interest was the mean difference between the groups estimated via linear regression models fitted at the child level using generalized estimating equations to allow for clustering of multiples, adjusted for multiple births (stratification variable used in the randomization process). The same analysis was completed for all secondary child outcomes. Given the small number of secondary caregivers providing data, only primary caregiver data were included, all from mothers. Estimands of interest for the maternal outcomes (mental health, quality of life) and parent–child relationship outcomes were the mean differences (continuous outcomes) or odds ratios (binary outcomes) between the groups, estimated via linear and logistic regression models fitted to the outcomes at 12 and 24 months separately, adjusted for multiple births. Results are presented with 95% confidence intervals (CIs) and corresponding P values. As a preplanned sensitivity analysis, all analyses were repeated with baseline continuous measures of parental depression, anxiety, and social risk added as covariates. The sex of the child was also included in posthoc sensitivity analyses because of an unexpected group difference in sex of child.

The study was designed to detect an increase in cognitive scores on the Bayley-III with the intervention of at least 0.3 SD, with 80% power and a type-I error rate of 5%, which required 176 participants in each group. Assuming that 25% of the sample would be twins (average cluster size = 1.25) and an intraclass correlation coefficient of 0.75 between twins, the required sample size was inflated by a design effect of 1.19. Allowing for 10% lost to follow-up at 24 months, the plan was to recruit 232 infants per arm. Recruitment stopped early because of insufficient funds, with 103 infants recruited. Given the study was underpowered, interpretation of results focused on the magnitude of group differences.

Figure 1 includes a flowchart of participant recruitment and follow-up.

FIGURE 1

Consort flowchart of participant recruitment and follow-up.

FIGURE 1

Consort flowchart of participant recruitment and follow-up.

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We recruited 103 infants from 83 families: 63 singleton infants from singleton births and their mothers and 40 infants from multiple births and their mothers. Data from secondary caregivers were not included because of low numbers. Of the multiple births, there were 18 sets of twins, 1 set of triplets, and 1 infant whose twin sibling died in the neonatal period before the family was randomly assigned. Three infants in the control group died within the first year after birth (2 singletons and 1 twin). There were more male infants in the intervention than in the control group. All other characteristics were similar between groups, although rates of bronchopulmonary dysplasia appeared higher in the control group (Table 1).

At 24 months CA, there were infant and/or maternal data for 93 infants (93% of the recruited sample, excluding the 3 infants who died). Compared with those with data at 24 months, those without data had higher infant birth weights and gestational ages (Supplemental Table 7).

For those who responded, rates of accessing services for the child and mother over the first 2 years were similar between groups (Table 1). For the intervention group, the average number of clinician contacts was 11 (range 5–18).

There was little difference in mean cognitive development scores between groups in the primary or the sensitivity analysis (Table 2).

TABLE 2

Child Outcomes at 24 Months

Intervention Mean, n (SD)Control Mean, n (SD)Mean Difference (95% CI)aPSensitivity Analysis Mean Difference (95% CI)bP
Primary outcome       
 Cognitive composite 99.9 (18.1)c 100.8 (14.8)d 1.7 (−5.8 to 9.1) .66 3.9 (−2.8 to 10.5) .26 
Secondary outcomes       
 Language composite 102.6 (23.4)e 102.3 (21.5)f 3.3 (−7.0 to 13.6) .53 5.9 (−3.7 to 15.4) .23 
 Motor composite 100.6 (16.4)c 101.9 (14.9)f 0.0 (−7.1 to 7.1) .99 2.7 (−4.1 to 9.5) .43 
 Externalizing score 48.4 (9.8)f 46.9 (9.0)c 2.2 (−2.2 to 6.6) .34 1.9 (−2.6 to 6.3) .41 
 Internalizing score 43.1 (7.9)f 46.4 (10.3)c −2.6 (−6.8 to 1.7) .24 −2.3 (−6.6 to 1.9) .28 
 Dysregulation score 44.9 (11.9)f 44.4 (13.0)c 0.6 (−4.9 to 6.2) .82 1.0 (−4.5 to 6.5) .73 
 Competence score 47.9 (13.0)f 48.9 (9.1)c −0.8 (−6.5 to 4.9) .79 −0.2 (−5.7 to 5.4) .96 
Intervention Mean, n (SD)Control Mean, n (SD)Mean Difference (95% CI)aPSensitivity Analysis Mean Difference (95% CI)bP
Primary outcome       
 Cognitive composite 99.9 (18.1)c 100.8 (14.8)d 1.7 (−5.8 to 9.1) .66 3.9 (−2.8 to 10.5) .26 
Secondary outcomes       
 Language composite 102.6 (23.4)e 102.3 (21.5)f 3.3 (−7.0 to 13.6) .53 5.9 (−3.7 to 15.4) .23 
 Motor composite 100.6 (16.4)c 101.9 (14.9)f 0.0 (−7.1 to 7.1) .99 2.7 (−4.1 to 9.5) .43 
 Externalizing score 48.4 (9.8)f 46.9 (9.0)c 2.2 (−2.2 to 6.6) .34 1.9 (−2.6 to 6.3) .41 
 Internalizing score 43.1 (7.9)f 46.4 (10.3)c −2.6 (−6.8 to 1.7) .24 −2.3 (−6.6 to 1.9) .28 
 Dysregulation score 44.9 (11.9)f 44.4 (13.0)c 0.6 (−4.9 to 6.2) .82 1.0 (−4.5 to 6.5) .73 
 Competence score 47.9 (13.0)f 48.9 (9.1)c −0.8 (−6.5 to 4.9) .79 −0.2 (−5.7 to 5.4) .96 
a

Adjusted for multiple birth.

b

Adjusted for multiple birth, sex of child, and baseline social risk and depression and anxiety symptoms in the mother.

c

n = 42

d

n = 40

e

n = 41

f

n = 39

There was little difference between groups on mean language, motor, or social-emotional development scores in the primary or the sensitivity analysis, although a 4- to 6-point difference between groups on cognitive and language outcomes was noted in the sensitivity analysis (Table 2).

There was little difference between groups for mean scores on depression, anxiety, or posttraumatic stress symptoms. Although the proportions in the elevated category for anxiety at 12 or 24 months in the primary and the sensitivity analysis were similar for the groups (Table 3), there was some evidence that being in the intervention group was associated with lower odds of being in the elevated category for depression at 12 months CA, which persisted in the sensitivity analysis.

TABLE 3

Parental Mental Health Outcomes at 12 and 24 Months

InterventionControlMean Difference or Odds Ratio (95% CI)aPSensitivity Analysis: Mean Difference or Odds Ratio (95% CI)bP
12 mo n = 32 n = 34 — — — — 
 Depression: symptoms, mean (SD) 6.3 (5.0) 8.3 (8.1) −1.98 (−5.33 to 1.37) .24 −2.06 (−4.99 to 0.87) .16 
 Depression: elevated, n (%) 2 (6%) 9 (26%) 0.19c (0.04 to 0.96) .04 0.05c (0.00 to 0.84) .04 
 Anxiety: symptoms, mean (SD) 2.7 (3.3) 3.4 (3.5) −0.72 (−2.40 to 0.96) .39 −0.72 (−2.33 to 0.89) .38 
 Anxiety: elevated, n (%) 1 (3%) 2 (6%) 0.49c (0.04 to 5.80) .57 0.51c (0.04 to 6.69) .61 
24 mo n = 33 n = 33 — — — — 
 Depression: symptoms, mean (SD) 6.6 (7.4) 6.0 (6.6) 0.45 (−2.99 to 3.89) .79 0.17 (−3.29 to 3.63) .92 
 Depression: elevated, n (%) 3 (9%) 2 (6%) 1.39c (0.21 to 9.43) .74 0.76c (0.05 to 10.5) .84 
 Anxiety: symptoms, mean (SD) 2.6 (2.9) 2.7 (2.9) −0.04 (−1.47 to 1.38) .95 −0.09 (−1.50 to 1.33) .90 
 Anxiety: elevated, n (%) 1 (3%) 2 (6%) 0.40c (0.03 to 4.96) .47 0.02c (0.00 to 15.5) .26 
 Posttraumatic stress symptoms, mean (SD) 6.2 (7.3) 5.5 (5.6) 0.62 (−2.70 to 3.94) .70 0.55 (−2.73 to 3.82) .74 
InterventionControlMean Difference or Odds Ratio (95% CI)aPSensitivity Analysis: Mean Difference or Odds Ratio (95% CI)bP
12 mo n = 32 n = 34 — — — — 
 Depression: symptoms, mean (SD) 6.3 (5.0) 8.3 (8.1) −1.98 (−5.33 to 1.37) .24 −2.06 (−4.99 to 0.87) .16 
 Depression: elevated, n (%) 2 (6%) 9 (26%) 0.19c (0.04 to 0.96) .04 0.05c (0.00 to 0.84) .04 
 Anxiety: symptoms, mean (SD) 2.7 (3.3) 3.4 (3.5) −0.72 (−2.40 to 0.96) .39 −0.72 (−2.33 to 0.89) .38 
 Anxiety: elevated, n (%) 1 (3%) 2 (6%) 0.49c (0.04 to 5.80) .57 0.51c (0.04 to 6.69) .61 
24 mo n = 33 n = 33 — — — — 
 Depression: symptoms, mean (SD) 6.6 (7.4) 6.0 (6.6) 0.45 (−2.99 to 3.89) .79 0.17 (−3.29 to 3.63) .92 
 Depression: elevated, n (%) 3 (9%) 2 (6%) 1.39c (0.21 to 9.43) .74 0.76c (0.05 to 10.5) .84 
 Anxiety: symptoms, mean (SD) 2.6 (2.9) 2.7 (2.9) −0.04 (−1.47 to 1.38) .95 −0.09 (−1.50 to 1.33) .90 
 Anxiety: elevated, n (%) 1 (3%) 2 (6%) 0.40c (0.03 to 4.96) .47 0.02c (0.00 to 15.5) .26 
 Posttraumatic stress symptoms, mean (SD) 6.2 (7.3) 5.5 (5.6) 0.62 (−2.70 to 3.94) .70 0.55 (−2.73 to 3.82) .74 
a

Adjusted for multiple birth.

b

Adjusted for multiple birth, sex of child, and baseline social risk and depression and anxiety symptoms in the mother.

c

Odds ratio.

There was little difference between groups for mean scores on quality of life for almost all domains at 12 or 24 months (Table 4). There was, however, weak evidence that being in the intervention group was associated with better quality of life in the mental health domain at 12 months CA. Sensitivity analysis did not alter conclusions.

TABLE 4

Parental Quality of Life Domains at 12 and 24 Months

Intervention Mean (SD)Control Mean (SD)Mean Difference (95% CI)aPSensitivity Analysis: Mean Difference (95% CI)bP
12 mo n = 32 n = 34 — — — — 
 Independent living 6.0 (2.0) 6.8 (2.6) −0.7 (−1.9 to 0.4) .20 −0.8 (−1.9 to 0.3) .16 
 Pain 4.2 (1.6) 4.7 (2.1) −0.5 (−1.4 to 0.4) .29 −0.5 (−1.5 to 0.4) .26 
 Senses 3.8 (1.0) 4.2 (1.1) −0.4 (−0.9 to 0.2) .17 −0.3 (−0.9 to 0.2) .21 
 Happiness 8.1 (1.7) 8.3 (1.9) −0.2 (−1.1 to 0.7) .65 −0.2 (−1.1 to 0.7) .60 
 Mental health 14.5 (2.9) 16.1 (3.6) −1.5 (−3.1 to 0.1) .06 −1.5 (−3.0 to -0.1) .04 
 Coping 6.4 (1.3) 6.5 (1.6) −0.2 (−0.9 to 0.6) .69 −0.2 (−0.9 to 0.5) .61 
 Relationships 10.8 (2.5) 11.7 (2.8) −0.9 (−2.3 to 0.4) .16 −1.0 (−2.2 to 0.3) .12 
 Self-worth 5.3 (1.4) 5.7 (2.2) −0.4 (−1.4 to 0.5) .36 −0.4 (−1.3 to 0.4) .32 
24 mo n = 33 n = 33 — — — — 
 Independent living 6.3 (2.5) 5.8 (2.3) 0.4 (−0.8 to 1.6) .51 0.3 (−0.9 to 1.6) .59 
 Pain 4.1 (1.6) 3.8 (1.2) 0.3 (−0.4 to 1.0) .37 0.2 (−0.5 to 0.9) .49 
 Senses 3.9 (1.1) 3.9 (1.0) −0.0 (−0.5 to 0.5) .97 0.0 (−0.5 to 0.6) .88 
 Happiness 8.2 (2.2) 7.9 (2.1) 0.2 (−0.9 to 1.3) .70 0.1 (−1.0 to 1.2) .81 
 Mental health 15.0 (4.1) 14.6 (3.1) 0.4 (−1.4 to 2.2) .66 0.4 (−1.5 to 2.2) .68 
 Coping 6.4 (1.9) 6.1 (1.5) 0.3 (−0.5 to 1.2) .41 0.4 (−0.5 to 1.2) .37 
 Relationships 11.7 (3.7) 10.9 (3.2) 0.7 (−1.0 to 2.4) .43 0.6 (−1.2 to 2.3) .53 
 Self-worth 5.5 (1.9) 5.2 (1.7) 0.3 (−0.7 to 1.2) .58 0.3 (−0.7 to 1.2) .59 
Intervention Mean (SD)Control Mean (SD)Mean Difference (95% CI)aPSensitivity Analysis: Mean Difference (95% CI)bP
12 mo n = 32 n = 34 — — — — 
 Independent living 6.0 (2.0) 6.8 (2.6) −0.7 (−1.9 to 0.4) .20 −0.8 (−1.9 to 0.3) .16 
 Pain 4.2 (1.6) 4.7 (2.1) −0.5 (−1.4 to 0.4) .29 −0.5 (−1.5 to 0.4) .26 
 Senses 3.8 (1.0) 4.2 (1.1) −0.4 (−0.9 to 0.2) .17 −0.3 (−0.9 to 0.2) .21 
 Happiness 8.1 (1.7) 8.3 (1.9) −0.2 (−1.1 to 0.7) .65 −0.2 (−1.1 to 0.7) .60 
 Mental health 14.5 (2.9) 16.1 (3.6) −1.5 (−3.1 to 0.1) .06 −1.5 (−3.0 to -0.1) .04 
 Coping 6.4 (1.3) 6.5 (1.6) −0.2 (−0.9 to 0.6) .69 −0.2 (−0.9 to 0.5) .61 
 Relationships 10.8 (2.5) 11.7 (2.8) −0.9 (−2.3 to 0.4) .16 −1.0 (−2.2 to 0.3) .12 
 Self-worth 5.3 (1.4) 5.7 (2.2) −0.4 (−1.4 to 0.5) .36 −0.4 (−1.3 to 0.4) .32 
24 mo n = 33 n = 33 — — — — 
 Independent living 6.3 (2.5) 5.8 (2.3) 0.4 (−0.8 to 1.6) .51 0.3 (−0.9 to 1.6) .59 
 Pain 4.1 (1.6) 3.8 (1.2) 0.3 (−0.4 to 1.0) .37 0.2 (−0.5 to 0.9) .49 
 Senses 3.9 (1.1) 3.9 (1.0) −0.0 (−0.5 to 0.5) .97 0.0 (−0.5 to 0.6) .88 
 Happiness 8.2 (2.2) 7.9 (2.1) 0.2 (−0.9 to 1.3) .70 0.1 (−1.0 to 1.2) .81 
 Mental health 15.0 (4.1) 14.6 (3.1) 0.4 (−1.4 to 2.2) .66 0.4 (−1.5 to 2.2) .68 
 Coping 6.4 (1.9) 6.1 (1.5) 0.3 (−0.5 to 1.2) .41 0.4 (−0.5 to 1.2) .37 
 Relationships 11.7 (3.7) 10.9 (3.2) 0.7 (−1.0 to 2.4) .43 0.6 (−1.2 to 2.3) .53 
 Self-worth 5.5 (1.9) 5.2 (1.7) 0.3 (−0.7 to 1.2) .58 0.3 (−0.7 to 1.2) .59 
a

Adjusted for multiple birth.

b

Adjusted for multiple birth, sex of child, and baseline social risk and depression and anxiety symptoms in the mother.

There was evidence for higher (more optimal) scores in child responsiveness, child involvement, and sensitive, structuring, and nonhostile parenting behavior in mothers in the intervention compared with the control group (Table 5). These relationships were stronger in sensitivity analyses.

TABLE 5

Parent–Child Relationship Outcomes at 24 Months

Intervention Mean (SD), n = 39Control Mean (SD), n = 32Mean Difference (95% CI)aPSensitivity Analysis: Mean Difference (95% CI)bP
Child responsiveness 5.7 (0.6) 5.1 (1.3) 0.6 (0.0 to 1.1) .04 0.7 (0.1 to 1.2) .02 
Child involvement 5.5 (0.8) 4.9 (1.3) 0.6 (0.1 to 1.1) .02 0.7 (0.2 to 1.2) .01 
Maternal sensitivity 5.7 (0.8) 5.1 (1.3) 0.5 (−0.1 to 1.0) .08 0.6 (−0.0 to 1.1) .05 
Maternal structuring 5.6 (0.7) 4.9 (1.2) 0.7 (0.2 to 1.2) .01 0.8 (0.4 to 1.3) .001 
Maternal nonintrusiveness 5.8 (0.9) 5.3 (1.1) 0.5 (−0.1 to 1.1) .11 0.6 (0.0 to 1.1) .04 
Maternal nonhostility 6.6 (0.8) 6.2 (0.9) 0.4 (−0.1 to 0.9) .09 0.5 (0.1 to 0.9) .03 
Intervention Mean (SD), n = 39Control Mean (SD), n = 32Mean Difference (95% CI)aPSensitivity Analysis: Mean Difference (95% CI)bP
Child responsiveness 5.7 (0.6) 5.1 (1.3) 0.6 (0.0 to 1.1) .04 0.7 (0.1 to 1.2) .02 
Child involvement 5.5 (0.8) 4.9 (1.3) 0.6 (0.1 to 1.1) .02 0.7 (0.2 to 1.2) .01 
Maternal sensitivity 5.7 (0.8) 5.1 (1.3) 0.5 (−0.1 to 1.0) .08 0.6 (−0.0 to 1.1) .05 
Maternal structuring 5.6 (0.7) 4.9 (1.2) 0.7 (0.2 to 1.2) .01 0.8 (0.4 to 1.3) .001 
Maternal nonintrusiveness 5.8 (0.9) 5.3 (1.1) 0.5 (−0.1 to 1.1) .11 0.6 (0.0 to 1.1) .04 
Maternal nonhostility 6.6 (0.8) 6.2 (0.9) 0.4 (−0.1 to 0.9) .09 0.5 (0.1 to 0.9) .03 
*

Higher scores represent more optimal behavior.

a

Adjusted for multiple birth.

b

Adjusted for multiple birth, sex of child, and baseline social risk and depression and anxiety symptoms in the mother.

Despite study cessation before reaching the planned sample size, we found evidence that a clinician-supported, web-based early intervention program for families after preterm birth was associated with more optimal parent–child relationships and some maternal mental health benefits at 12 months, specifically lower rates of elevated depression symptoms and better mental health-related quality of life. At 24 months CA, child cognitive, language, motor and social–emotional development, and maternal mental health were similar for intervention and control groups. Although promising, the positive effects on the parent–child relationship and mental health should be considered preliminary evidence because of the reduced sample size.

Child outcomes that were similar between the intervention and control groups were contrary to expectations based on the meta-analysis of early intervention for children born preterm.8  However, our ability to detect group effects was likely reduced because of the low sample size resulting in a lack of power. Improvements in mothers’ mental health at 12 months CA occurred when the active intervention was concluding and were not sustained 12 months later. This is contrary to the broader and sustained positive effect on maternal mental health reported by our home visiting program14  and may be related to limited power in the current study. It is worth noting that rates of elevated depression and anxiety scores in both groups at 2 years in the current study (8% and 5%, respectively) were lower than in previous research (eg, 25% at 2 years),7  which may have limited the potential for the intervention to improve mothers’ mental health. It is also possible that families in both groups were accessing other interventions or mental health services as part of standard care, which was not assessed and may have influenced outcomes across both groups.

A promising finding from the current study was the positive effect of the intervention on the parent–child relationship. The behavior of children in the intervention group was observed to be more responsive and involved during interactions with their mothers than in the control group. It is likely that these changes in children’s behavior were driven by parenting behavior, supported by the pattern of maternal behavior in the intervention group that was more structuring, more sensitive, less intrusive, and less hostile. The parenting domain revealing the strongest intervention effect was maternal structuring, with mothers in the intervention group more likely to structure the interaction with their child in a way that was appropriate and successful in facilitating play, following the child’s lead, and setting appropriate limits than mothers in the control group. These are encouraging results because parenting higher in facilitation is associated with better developmental outcomes for children born preterm,20  and research reveals the parent–child relationship may be an important mechanism for positive effects of early intervention.27,28  Additional follow-up of children in the current study would clarify potential delayed or indirect effects on children’s outcomes that may be mediated through changes in parenting.

Research supports the effectiveness of web-based parenting programs.29  Web-based or technology-assisted interventions may be effective in improving child and parent outcomes for families with an increased social disadvantage compared with families with less social disadvantage.17,30  This is important for families with preterm children, for whom greater social disadvantage has been associated with a lower likelihood of accessing early intervention services.31  One element of effective telehealth interventions is clinician support, with greater effects seen for clinician-assisted online interventions for adult mental health32  and parenting programs29  compared with self-guided interventions. Future interventions could include telehealth to allow clinicians to provide real-time support and feedback. Videoconferencing technology available precoronavirus 2019 pandemic was offered but not taken up by any families in the current study. The current intervention design integrated clinician support and web-based content, meaning it was not possible to isolate and evaluate the efficacy of these elements.

Conclusions that can be drawn from the current study are limited by the small sample size, and lack of power to detect group differences. Despite lack of power, results suggested improvements in parenting and child relational behavior for the intervention group. By chance, there were more boys in the intervention group but sensitivity analyses adjusting for sex of the child did not alter the conclusion about the effect of the intervention on the parent–child relationship. Because there is evidence for greater vulnerabilities for boys born preterm33  and differences in the influence of parenting on brain development for male and female children,34,35  additional investigation into potential interactions between the sex of the child and intervention outcomes is warranted. Other potential moderators of intervention effectiveness such as infant gestational age and familial social risk are also important to consider in future studies.

The intervention was only available in English, which limits the generalizability of results to families in which the primary caregiver could not read or speak English. Most mothers in the study were tertiary educated and families were classified as lower social risk, which is not representative of the population of the state of Victoria.36  Future studies targeting families from higher social risk backgrounds and incorporating translated and culturally appropriate materials and clinicians who speak languages other than English are important. Despite attempting to recruit secondary caregivers (primarily fathers) into the study, participation rates were low and engagement with the intervention was variable, with 24-month outcome data only available for 8 secondary caregivers. This limited the analysis of secondary caregivers. Research suggests that preterm birth increases the risk for psychological distress for fathers5  but also that increased paternal structuring behavior is associated with more optimal cognitive and language development in full and preterm children.37  Because of this, deliberately considering partners of the primary caregiver in intervention design and targeting partners in recruitment is critical to maximizing the benefits of intervention for families with children born preterm.

Preliminary findings from this clinician-supported, web-based early intervention program for infants born after <34 weeks’ gestation and their families suggest it has a positive effect on the parent–child relationship at 24 months and maternal mental health at 12 months but little effect on child development or parental mental health at 24 months. Our results support additional larger-scale evaluations of web-based early intervention programs for families after preterm birth.

We would like to thank the families involved in the research and acknowledge the contributions of the Victorian Infant Brain Studies team at the Murdoch Children’s Research Institute, the Newborn Research team at the Royal Women’s Hospital, and the Life’s Little Treasures Foundation.

Dr Treyvaud conceptualized and designed the study and analysis plan, coordinated and supervised data collection, collected data and delivered the intervention, conducted the analyses, drafted the initial manuscript, and critically reviewed and revised the manuscript; Dr Eeles conceptualized and designed the study, coordinated and supervised data collection, collected data and delivered the intervention, and critically reviewed and revised the manuscript; Drs Spittle, Cheong, Doyle, and Anderson conceptualized and designed the study, coordinated and supervised data collection, and critically reviewed and revised the manuscript; Dr Lee conceptualized and designed the study and analysis plan, contributed to interpretation of analyses, and critically reviewed and revised the manuscript; Ms Shah reviewed and revised the manuscript and was involved in study design as a consumer representative; and all authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

This trial has been prospectively registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366909) (ANZCTR 12614000906651).

Deidentified individual participant data will not be made available.

FUNDING: This work was supported by National Health and Medical Research Council (Centre for Research Excellence in Newborn Medicine 1060733 and 1153176; project grants 1024516, 1028822; Career Development Fellowship 1108714 to Dr Spittle and 1127984 to Dr Lee; Senior Research Fellowship 1081288 to Dr Anderson; Investigator Grant 1176077 to Dr Anderson). Murdoch Children’s Research Institute is supported by the Victorian Government’s Operational Infrastructure Support Program.

CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no potential conflicts of interest relevant to this article to disclose.

CA

corrected age

CI

confidence interval

SD

standard deviation

1
Anderson
P
,
Doyle
LW
;
Victorian Infant Collaborative Study Group
.
Neurobehavioral outcomes of school-age children born extremely low birth weight or very preterm in the 1990s
.
JAMA
.
2003
;
289
(
24
):
3264
3272
2
Johnson
S
,
Marlow
N
.
Preterm birth and childhood psychiatric disorders
.
Pediatr Res
.
2011
;
69
(
5 Pt 2
):
11R
18R
3
Cheong
JL
,
Doyle
LW
.
Increasing rates of prematurity and epidemiology of late preterm birth
.
J Paediatr Child Health
.
2012
;
48
(
9
):
784
788
4
Treyvaud
K
.
Parent and family outcomes following very preterm or very low birth weight birth: a review
.
Semin Fetal Neonatal Med
.
2014
;
19
(
2
):
131
135
5
Pace
CC
,
Spittle
AJ
,
Molesworth
CML
, et al
.
Evolution of depression and anxiety symptoms in parents of very preterm infants during the newborn period
.
JAMA Pediatr
.
2016
;
170
(
9
):
863
870
6
Davis
L
,
Edwards
H
,
Mohay
H
,
Wollin
J
.
The impact of very premature birth on the psychological health of mothers
.
Early Hum Dev
.
2003
;
73
(
1-2
):
61
70
7
Yaari
M
,
Treyvaud
K
,
Lee
KJ
,
Doyle
LW
,
Anderson
PJ
.
Preterm birth and maternal mental health: longitudinal trajectories and predictors
.
J Pediatr Psychol
.
2019
;
44
(
6
):
736
747
8
Spittle
A
,
Orton
J
,
Anderson
PJ
,
Boyd
R
,
Doyle
LW
.
Early developmental intervention programmes provided post hospital discharge to prevent motor and cognitive impairment in preterm infants
.
Cochrane Database Syst Rev
.
2015
;
2015
(
11
):
CD005495
9
Vanderveen
JA
,
Bassler
D
,
Robertson
CMT
,
Kirpalani
H
.
Early interventions involving parents to improve neurodevelopmental outcomes of premature infants: a meta-analysis
.
J Perinatol
.
2009
;
29
(
5
):
343
351
10
Herd
M
,
Whittingham
K
,
Sanders
M
,
Colditz
P
,
Boyd
RN
.
Efficacy of preventative parenting interventions for parents of preterm infants on later child behavior: a systematic review and meta-analysis
.
Infant Ment Health J
.
2014
;
35
(
6
):
630
641
11
Benzies
KM
,
Magill-Evans
JE
,
Hayden
KA
,
Ballantyne
M
.
Key components of early intervention programs for preterm infants and their parents: a systematic review and meta-analysis
.
BMC Pregnancy Childbirth
.
2013
;
13
(
Suppl 1
):
S10
12
Spittle
AJ
,
Anderson
PJ
,
Lee
KJ
, et al
.
Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years
.
Pediatrics
.
2010
;
126
(
1
):
e171
e178
13
Puthussery
S
,
Chutiyami
M
,
Tseng
PC
,
Kilby
L
,
Kapadia
J
.
Effectiveness of early intervention programs for parents of preterm infants: a meta-review of systematic reviews
.
BMC Pediatr
.
2018
;
18
(
1
):
223
14
Spencer-Smith
MM
,
Spittle
AJ
,
Doyle
LW
, et al
.
Long-term benefits of home-based preventive care for preterm infants: a randomized trial
.
Pediatrics
.
2012
;
130
(
6
):
1094
1101
15
Greist
JH
.
Treatment for all: the computer as a patient assistant
.
Psychiatr Serv
.
1998
;
49
(
7
):
887
889
16
Griffiths
KM
,
Farrer
L
,
Christensen
H
.
The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials
.
Med J Aust
.
2010
;
192
(
S11
):
S4
S11
17
Wade
SL
,
Carey
J
,
Wolfe
CR
.
The efficacy of an online cognitive-behavioral family intervention in improving child behavior and social competence following pediatric brain injury
.
Rehabil Psychol
.
2006
;
51
:
179
189
18
Cox
JL
,
Holden
JM
,
Sagovsky
R
.
Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale
.
Br J Psychiatry
.
1987
;
150
:
782
786
19
Spitzer
RL
,
Kroenke
K
,
Williams
JBW
,
Löwe
B
.
A brief measure for assessing generalized anxiety disorder: the GAD-7
.
Arch Intern Med
.
2006
;
166
(
10
):
1092
1097
20
Treyvaud
K
,
Anderson
VA
,
Howard
K
, et al
.
Parenting behavior is associated with the early neurobehavioral development of very preterm children
.
Pediatrics
.
2009
;
123
(
2
):
555
561
21
Bayley
N
.
Bayley Scales of Infant and Toddler Development
, 3rd ed.
San Antonio, TX
:
PsychCorp
;
2005
22
Carter
AS
,
Briggs-Gowan
MJ
.
Infant-Toddler Social and Emotional Assessment: Examiner’s Manual
.
San Antonio, TX
:
Pearson
;
2006
23
Radloff
LS
.
The CES-D Scale: a self-report depression scale for research in the general population
.
Appl Psychol Meas
.
1977
;
1
:
385
401
24
Weathers
FW
,
Litz
BT
,
Keane
TM
,
Palmieri
PA
,
Marx
BP
,
Schnurr
PP
;
US Department of Veterans Affairs
.
The PTSD checklist for DSM-5 (PCL-5)
.
25
Richardson
J
.
Modelling the Utility of Health States with the Assessment of Quality of Life (AQoL) 8D Instrument. Overview and Utility Scoring Algorithm
.
Melbourne, Australia
:
Centre for Health Economics, Monash University
;
2011
26
Biringen
Z
.
The Emotional Availability (EA) Scales
. 4th ed.
Boulder, CO
:
International Center for Excellence in Emotional Availability
;
2008
27
Brett
J
,
Staniszewska
S
,
Newburn
M
,
Jones
N
,
Taylor
L
.
A systematic mapping review of effective interventions for communicating with, supporting and providing information to parents of preterm infants
.
BMJ Open
.
2011
;
1
(
1
):
e000023
28
Guralnick
MJ
.
Preventive interventions for preterm children: effectiveness and developmental mechanisms
.
J Dev Behav Pediatr
.
2012
;
33
(
4
):
352
364
29
Nieuwboer
C
,
Fukkink
R
,
Hermanns
J
.
Online programs as tools to improve parenting: a meta-analytic review
.
Child Youth Serv Rev
.
2013
;
35
:
1823
1829
30
Petranovich
CL
,
Wade
SL
,
Taylor
HG
, et al
.
Long-term caregiver mental health outcomes following a predominately online intervention for adolescents with complicated mild to severe traumatic brain injury
.
J Pediatr Psychol
.
2015
;
40
(
7
):
680
688
31
Roberts
G
,
Howard
K
,
Spittle
AJ
,
Brown
NC
,
Anderson
PJ
,
Doyle
LW
.
Rates of early intervention services in very preterm children with developmental disabilities at age 2 years
.
J Paediatr Child Health
.
2008
;
44
(
5
):
276
280
32
Richards
D
,
Richardson
T
.
Computer-based psychological treatments for depression: a systematic review and meta-analysis
.
Clin Psychol Rev
.
2012
;
32
(
4
):
329
342
33
Peacock
JL
,
Marston
L
,
Marlow
N
,
Calvert
SA
,
Greenough
A
.
Neonatal and infant outcome in boys and girls born very prematurely
.
Pediatr Res
.
2012
;
71
(
3
):
305
310
34
Whittle
S
,
Simmons
JG
,
Dennison
M
, et al
.
Positive parenting predicts the development of adolescent brain structure: a longitudinal study
.
Dev Cogn Neurosci
.
2014
;
8
:
7
17
35
Treyvaud
K
,
Thompson
DK
,
Kelly
CE
, et al
.
Early parenting is associated with the developing brains of children born very preterm
.
Clin Neuropsychol
.
2021
;
35
(
5
):
885
903
36
Cheong
JLY
,
Olsen
JE
,
Lee
KJ
, et al;
Victorian Infant Collaborative Study Group
.
Temporal trends in neurodevelopmental outcomes to 2 years after extremely preterm birth
.
JAMA Pediatr
.
2021
;
175
(
10
):
1035
1042
37
McMahon
GE
,
Spencer-Smith
MM
,
Pace
CC
, et al
.
Influence of fathers’ early parenting on the development of children born very preterm and full term
.
J Pediatr
.
2019
;
205
:
195
201

Supplementary data