Preventing enduring behavioural problems in young children through early psychological intervention: Healthy Start, Happy Start

DESIGN: The study is a two-arm, parallel group, individually randomised controlled trial. SETTING: NHS primary health care settings in North London and Milton Keynes. Recruitment will take place via health visitor services. STRATEGY FOR REVIEWING LITERATURE: We have undertaken a systematic review of the available literature on early interventions for behavioural problems, including published systematic reviews, ongoing registered trials, and contact with experts in the field who are currently undertaking studies. TARGET POPULATION: Children aged 12-36 months old, who have been identified as at risk for behavioural problems by parental questionnaire, and their parents/caregivers. INCLUSION CRITERIA: i) child aged between 12-36 months; ii) child scores in the top 20% for behavioural problems on the Stregnths and Difficulties Questionnaire. EXCLUSION CRITERIA: i) index child has severe sensory impairment or learning disability; ii) carer has insufficient English to complete questionnaire assessments. HEALTH TECHNOLOGIES BEING ASSESSED: Video-Feedback to Promote Positive Parenting and Sensitive Discipline (VIPP-SD). We have selected this intervention as it has been developed and evaluated in a systematic way, and has a strong developing evidence base for early preventive intervention. It is a home-based, highly acceptable intervention, delivered over 6 sessions, at approximately fortnightly intervals. The intervention will be delivered to the primary caregiver, and to a second parent/carer as well if they are available. In addition, those in both the treatment and control arms will continue to receive usual care. MEASUREMENT OF COSTS AND OUTCOMES (PLUS JUSTIFICATION FOR THESE): The primary outcome will be Child Behaviour, assessed through a structured interview with the child’s parents/guardians (Pre-PACS interview). Secondary outcomes will include: Child Behaviour measured with the Child Behavior Checklist, a standard questionnaire measure completed by parents and a non-parental carer or teacher; Parental Mood (Beck Depression Inventory); Parental Relationship (Dyadic Adjustment Scale); Parenting Practice (Parenting Scale); and costs of care measured using the Child and Adolescent Service Use Schedule (CA-SUS). SAMPLE SIZE: A total sample of 300 families will be recruited. This will provide power to detect a standardized effect size in the range 0.34 - 0.42. This is a similar effect to that found in previous trials and would be a highly clinically relevant difference so early in childhood, and is likely to map onto large differences in outcome in later childhood and adult life. PROJECT TIMELINES INCLUDING RECRUITMENT RATE: 0-4 months. Set up study, recruit and train staff. Ethical and local R&D approvals will already have been sought. 5-25 months. Recruit participants. Deliver index treatment and control intervention. Recruitment period of 21 months at average rate of 14.2 participants per month. 9-49 months. Follow-up assessments at 4 and 24 months post-randomisation. 48-54 months. Analysis of findings and writing of final report and papers. EXPERTISE IN TEAM: This proposal is submitted by a multidisciplinary team which includes expertise in child mental health, parenting and early intervention research, mental health services research, statistics and health economics, and has the active involvement of a registered Clinical Trials Unit and voluntary parenting organisations.