CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 172 enrolled
Drug / intervention
Strongest Families Intervention (formerly Family Help)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01473511
NCT01473511Phase 3Completed

Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario

IWK Health Centre·interventional·Posted Nov 17, 2011·Updated Sep 2, 2016

In Brief

A Phase 3 clinical trial evaluating Strongest Families Intervention (formerly Family Help) for Oppositional Defiant Disorder and Behaviour Disorder. Completed, enrolled 172 participants across 1 site.

Detailed Summary

Strongest Families (formerly Family Help)is an evidence-based, distance health education model for families who have children with behavioural difficulties. The principal research question is "Does Strongest Families, a 12-week, home-based program of interactive readings, instructional videos, homework projects, and weekly "coaching" telephone calls out perform the care families typically experience when referred to a mental health service?". The investigators hypothesize that children randomized to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomized to a Control (usual care). In addition, parents randomized to Family Help will report a greater improvement in parenting skills and a greater reduction in symptoms of emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the Control condition. Finally, families randomized to Family Help will use fewer mental health services than Controls.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2011
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 14.6 years ago

Interventions

Strongest Families Intervention (formerly Family Help)behavioral

Distance HEALTH education intervention focussed on skill learning for parents