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A video-feedback parenting intervention to prevent enduring behaviour problems in at-risk children aged 12-36 months: the Healthy Start, Happy Start RCT

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Christine O'Farrelly, Beth Barker, Hilary Watt, Daphne Babalis, Marian Bakermans- Kranenburg, Sarah Byford, Poushali Ganguli, Ellen Grimas, Jane Iles, Holly Mattock, Julia McGinley, Charlotte Phillips, Rachael Ryan, Stephen Scott, Jessica Smith, Alan Stein, Eloise Stevens, Marinus H van IJzendoorn, Jane Warwick, Paul G Ramchandani

Original languageEnglish
Pages (from-to)1-84
Number of pages84
JournalHealth Technology Assessment
Volume25
Issue number29
DOIs
Published21 May 2021

Bibliographical note

Funding Information: Declared competing interests of authors: Marinus van IJzendoorn and Marian Bakermans-Kranenburg declare themselves as two of the developers of the VIPP-SD intervention. Paul Ramchandani has received funding in the form of a donation for research from the LEGO Foundation (Billund, Denmark). He was a member of the Psychological and Community Therapies Panel from 2009 to 2014. Funding Information: Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 29. See the NIHR Journals Library website for further project information. Funding Information: This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. Funding Information: This research was funded by the NIHR HTA programme (13/04/33). Additional funding was received from the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust and Imperial College London. Funding Information: T he trial was sponsored by Imperial College London. Publisher Copyright: © 2021 O’Farrelly et al. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

King's Authors

Abstract

Background: Behaviour problems emerge early in childhood and place children at risk for later psychopathology. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of a parenting intervention to prevent enduring behaviour problems in young children. Design: A pragmatic, assessor-blinded, multisite, two-arm, parallel-group randomised controlled trial. Setting: Health visiting services in six NHS trusts in England. Participants: A total of 300 at-risk children aged 12-36 months and their parents/caregivers. Interventions: Families were allocated in a 1: 1 ratio to six sessions of Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) plus usual care or usual care alone. Main outcome measures: The primary outcome was the Preschool Parental Account of Children’s Symptoms, which is a structured interview of behaviour symptoms. Secondary outcomes included caregiver-reported total problems on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The intervention effect was estimated using linear regression. Health and social care service use was recorded using the Child and Adolescent Service Use Schedule and cost-effectiveness was explored using the Preschool Parental Account of Children’s Symptoms. Results: In total, 300 families were randomised: 151 to VIPP-SD plus usual care and 149 to usual care alone. Follow-up data were available for 286 (VIPP-SD, n = 140; usual care, n = 146) participants and 282 (VIPP-SD, n = 140; usual care, n = 142) participants at 5 and 24 months, respectively. At the post-treatment (primary outcome) follow-up, a group difference of 2.03 on Preschool Parental Account of Children’s Symptoms (95% confidence interval 0.06 to 4.01; p = 0.04) indicated a positive treatment effect on behaviour problems (Cohen’s d = 0.20, 95% confidence interval 0.01 to 0.40). The effect was strongest for children’s conduct [1.61, 95% confidence interval 0.44 to 2.78; p = 0.007 (d = 0.30, 95% confidence interval 0.08 to 0.51)] versus attention deficit hyperactivity disorder symptoms [0.29, 95% confidence interval -1.06 to 1.65; p = 0.67 (d = 0.05, 95% confidence interval -0.17 to 0.27)]. The Child Behaviour Checklist [3.24, 95% confidence interval -0.06 to 6.54; p = 0.05 (d = 0.15, 95% confidence interval 0.00 to 0.31)] and the Strengths and Difficulties Questionnaire [0.93, 95% confidence interval -0.03 to 1.9; p = 0.06 (d = 0.18, 95% confidence interval -0.01 to 0.36)] demonstrated similar positive treatment effects to those found for the Preschool Parental Account of Children’s Symptoms. At 24 months, the group difference on the Preschool Parental Account of Children’s Symptoms was 1.73 [95% confidence interval -0.24 to 3.71; p = 0.08 (d = 0.17, 95% confidence interval -0.02 to 0.37)]; the effect remained strongest for conduct [1.07, 95% confidence interval -0.06 to 2.20; p = 0.06 (d = 0.20, 95% confidence interval -0.01 to 0.42)] versus attention deficit hyperactivity disorder symptoms [0.62, 95% confidence interval -0.60 to 1.84; p = 0.32 (d = 0.10, 95% confidence interval -0.10 to 0.30)], with little evidence of an effect on the Child Behaviour Checklist and the Strengths and Difficulties Questionnaire. The primary economic analysis showed better outcomes in the VIPP-SD group at 24 months, but also higher costs than the usual-care group (adjusted mean difference £1450, 95% confidence interval £619 to £2281). No treatment- or trial-related adverse events were reported. The probability of VIPP-SD being cost-effective compared with usual care at the 24-month follow-up increased as willingness to pay for improvements on the Preschool Parental Account of Children’s Symptoms increased, with VIPP-SD having the higher probability of being cost-effective at willingness-to-pay values above £800 per 1-point improvement on the Preschool Parental Account of Children’s Symptoms. Limitations: The proportion of participants with graduate-level qualifications was higher than among the general public. Conclusions: VIPP-SD is effective in reducing behaviour problems in young children when delivered by health visiting teams. Most of the effect of VIPP-SD appears to be retained over 24 months. However, we can be less certain about its value for money.

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