Strongest Families Ontario (Formerly the Family Help Program)

Phase 3

Completed

• Conditions: Oppositional Defiant Disorder; Behaviour Disorder
• Interventions: Behavioral: Strongest Families Intervention (formerly Family Help)

• Registration Number: NCT01473511
• Lead Sponsor: IWK Health Centre

Brief 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.

Detailed Description

Our project is designed to help families and children with mild or moderate symptoms early, before problems become worse and more difficult to treat.

The Strongest Families Program is a distance parenting program that was developed at the Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most families are able to manage these problems if they are given the skills to do so. The Strongest Families "Parenting the Active Child" Distance Program is done over the telephone; families do not have to travel to a centre to receive help. This program includes a handbook, videos and weekly phone calls between the parent and non-professional'coach'. The coach provides support to families, answer questions and guide parents as they learn the skills. Strongest Families has helped hundreds of families in Nova Scotia.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-11-14
• Study First Posted: 2011-11-17
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

Male or female individuals who meet all the following criteria are eligible for this trial:

• Child is aged 6 to 12 years and
• Completed and signed referral form from a participating intake site is received and
• Parent/legal guardian provides verbal, telephone consent to participate and
• Ability of participant to read and understand English (at a Grade 5 level) and
• There must be the reasonable intention that for the study duration the child will remain in the direct care of the participant and at the same address as the participant (2 years) and o Child presents with significant levels of disruptive behaviour based on the BCFPI results at the referring agent end and clinical evaluation of the corroborative study assessment measures.

Exclusion Criteria

Participants meeting one or more of the following criteria cannot be selected:

• Child is in the care of a child protective agency or currently being investigated by a child protective agency
• Child has received any form of behavioural treatment in the past 6 months
• Child is at an imminent risk of harm to themselves or others
• In the judgment of the investigator or delegate, any condition that may interfere with effective delivery of the study protocol/intervention program (i.e., High parental DASS-21 score, complex child symptomology, families who are unmotivated or are in complete chaos)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strongest Families Program + Usual care	Strongest Families Intervention (formerly Family Help)	50% randomized to receive Strongest Families intervention immediately as well as the usual care services available via the referring agency for the 22 month study period.

Primary Outcome Measures

Name	Time	Method
Child Behaviour Checklist	Baseline, 5, 10, 16, 22 months	Results will be analyzed as change from baseline over time

Secondary Outcome Measures

Name	Time	Method
Alabama Parenting questionnaire	Baseline, 5, 10, 16, 22 months	Results will be analyzed as change from baseline over time
SCAPI (economic)	Baseline,5, 10, 16, 22	Results will be analyzed as change from baseline over time
DASS-21	Baseline,5, 10, 16, 22	Results will be analyzed as change from baseline over time
Investigator designed disability measure	weekly during intervention	Results will be analyzed as change from baseline over time
Discrete Conjoint Preference survey: Investigator designed	baseline, 5, 16 months	We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.
Investigator designed Satisfaction measure	end of intervention	Participant satisfaction with this psychological intervention will be measured at the end of intervention that varies between participants, but on average is about 5 months post-randomization

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada