Abstract

Behavior problems are one of the most common mental health disorders in childhood and can undermine children's health, education, and employment outcomes into adulthood. There are few effective interventions for early childhood. To test the clinical effectiveness of a brief parenting intervention, the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD), in reducing behavior problems in children aged 12 to 36 months. The Healthy Start, Happy Start study was a 2-group, parallel-group, researcher-blind, multisite randomized clinical trial conducted via health visiting services in 6 National Health Service trusts in England. Baseline and 5-month follow-up data were collected between July 30, 2015, and April 27, 2018. Of 818 eligible families, 227 declined to participate, and 300 were randomized into the trial. Target participants were caregivers of children who scored in the top 20% for behavior problems on the Strengths and Difficulties Questionnaire. Participants were randomly allocated on a 1:1 basis to receive either VIPP-SD (n = 151) or usual care (n = 149), stratified by site and number of participating caregivers. Analysis was performed on an intention-to-treat basis. Statistical analysis was performed from September 5, 2019, to January 17, 2020. All families continued to access usual care. Families allocated to VIPP-SD were offered 6 home-based video-feedback sessions of 1 to 2 hours' duration every 2 weeks. The primary outcome was the score on an early childhood version of the Preschool Parental Account of Children's Symptoms, a semistructured interview of behavior symptoms, at 5 months after randomization. Secondary outcomes included caregiver-reported behavior problems on the Child Behavior Checklist and the Strengths and Difficulties Questionnaire. Among 300 participating children (163 boys [54%]; mean [SD] age, 23.0 [6.7] months), primary outcome data were available for 140 of 151 VIPP-SD participants (93%) and 146 of 149 usual care participants (98%). There was a mean difference in the total Preschool Parental Account of Children's Symptoms score of 2.03 (95% CI, 0.06-4.01; P = .04; Cohen d = 0.20 [95% CI, 0.01-0.40]) between trial groups, with fewer behavior problems in the VIPP-SD group, particularly conduct symptoms (mean difference, 1.61 [95% CI, 0.44-2.78]; P = .007; d = 0.30 [95% CI, 0.08-0.51]). Other child behavior outcomes showed similar evidence favoring VIPP-SD. No treatment or trial-related adverse events were reported. This study found that VIPP-SD was effective in reducing symptoms of early behavior problems in young children when delivered in a routine health service context. isrctn.org Identifier: ISRCTN58327365.

Highlights

  • MethodsStudy Design, Setting, and Participants Healthy Start, Happy Start was a 2-group, parallel-group, researcher-blind, multisite randomized clinical trials (RCTs).[17] The protocol was approved by a National Health Service (NHS) Ethics Committee and is available with the statistical analysis plan in Supplement 1

  • There was a mean difference in the total Preschool Parental Account of Children’s Symptoms score of 2.03 between trial groups, with fewer behavior problems in the VIPP-SD group, conduct symptoms

  • This study found that VIPP-SD was effective in reducing symptoms of early behavior problems in young children when delivered in a routine health service context

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Summary

Methods

Study Design, Setting, and Participants Healthy Start, Happy Start was a 2-group, parallel-group, researcher-blind, multisite RCT.[17] The protocol was approved by a National Health Service (NHS) Ethics Committee and is available with the statistical analysis plan in Supplement 1. Parents or caregivers provided written informed consent. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. Recruitment via 6 NHS trusts in the UK involved a screening stage followed by a trial stage. Recruitment to the screening stage was through face-to-face or postal contacts in health visiting services, supplemented by advertisements in other clinical and community services and online outlets. Screening identified families whose children scored in the top 20%

Results
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