Strongest Families Ontario (Formerly the Family Help Program)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oppositional Defiant Disorder, Behaviour Disorder

Intervention / Treatment
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* Behavioral: Strongest Families Intervention (formerly Family Help)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strongest Families Program + Usual care<br>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. | Behavioral: Strongest Families Intervention (formerly Family Help)<br>* Distance HEALTH education intervention focussed on skill learning for parents<br>* Other names: formerly the Family Help Program;|
| No Intervention: Usual care<br>50% randomized will not receive Strongest Families Intervention during the 22 month study phase, but will receive the usual care services available via the referring agency. At the end of the 22 month study period study participants will be offered the Strongest Families Intervention services. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Behaviour Checklist | Results will be analyzed as change from baseline over time | Baseline, 5, 10, 16, 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alabama Parenting questionnaire | Results will be analyzed as change from baseline over time | Baseline, 5, 10, 16, 22 months | 
| SCAPI (economic) | Results will be analyzed as change from baseline over time | Baseline,5, 10, 16, 22 | 
| DASS-21 | Results will be analyzed as change from baseline over time | Baseline,5, 10, 16, 22 | 
| Investigator designed Satisfaction measure | 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 | end of intervention | 
| Investigator designed disability measure | Results will be analyzed as change from baseline over time | weekly during intervention | 
| Discrete Conjoint Preference survey: Investigator designed | We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time. | baseline, 5, 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural intervention, Distance intervention, Parenting intervention