Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity 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 Attention Deficit/Hyperactivity Disorder. 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 (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity 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 Strongest Families (formerly 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 Attention Deficit/Hyperactivity Disorder)

Conditions
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Attention Deficit/Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: FHPADHD
* Behavioral: ADHD Standard Care


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 attention deficit/hyperactivity symptomology Exclusion Criteria: severe attention deficit/hyperactivity 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: 8 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: Treatment<br>FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention | Behavioral: FHPADHD<br>* Evidence-based psychological and behavioural distance intervention<br>* Other names: Strongest Families (formerly Family Help Program):;|
| Active Comparator: Control<br>ADHD Standard Care 50% randomized to receive standard/usual care for ADHD | Behavioral: ADHD Standard Care<br> <br> |

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 followup | 
| 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 |