Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder

Study Overview
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Brief Summary
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The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Disruptive Behaviour symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

Detailed Description
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The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior disorder will be randomized. The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional coach who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team. Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Official Title
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Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)

Conditions
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Pediatric Disruptive Behaviour Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child 3 to 7 years of age child had behavioural problems for 6 months or longer access to a telephone in the home speak and write english mild to moderate disruptive behaviour symptomology Exclusion Criteria: severe disruptive behaviour symptomology received similar intervention within past 6 months Autism or Schizophrenia child has intellectual impairment

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 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: Treatment<br>50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment | Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program<br>* Evidence-based psychological and behavioural Distance Intervention<br>* Other names: Strongest Families (formerly Family Help Program):;|
| Active Comparator: Control<br>50% randomized to control group: standard/usual care for behaviour disorder | Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program<br>* Evidence-based psychological and behavioural Distance Intervention<br>* Other names: Strongest Families (formerly Family Help Program):;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. |  | baseline, 120, 240 and 365 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alabama Parenting Questionnaire |  | baseline, 120, 240 and 365 day follow-up | 
| Revised Disruptive Disorder Rating Scale |  | baseline, 120, 240 and 365 day follow-up | 
| Connors rating scale |  | baseline, 120, 240 and 365 day follow-up | 
| Disability Measure; |  | Weekly during treatment; baseline, 120, 240 and 365 day follow-up | 
| Child Health Questionnaire |  | baseline, 120, 240 and 365 day follow-up | 
| Economic Outcome assessment |  | baseline, 120, 240 and 365 day follow-up |