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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Pediatric Disruptive Behaviour Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment

Group Type EXPERIMENTAL

Strongest Families (formerly Family Help Program): Behaviour Disorder Program

Intervention Type BEHAVIORAL

Evidence-based psychological and behavioural Distance Intervention

Control

50% randomized to control group: standard/usual care for behaviour disorder

Group Type ACTIVE_COMPARATOR

Strongest Families (formerly Family Help Program): Behaviour Disorder Program

Intervention Type BEHAVIORAL

Evidence-based psychological and behavioural Distance Intervention

Interventions

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Strongest Families (formerly Family Help Program): Behaviour Disorder Program

Evidence-based psychological and behavioural Distance Intervention

Intervention Type BEHAVIORAL

Other Intervention Names

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Strongest Families (formerly Family Help Program):

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes