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

IWK Health Centre

Status and phase: Completed; Phase 2

Conditions: Pediatric Disruptive Behaviour Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00267579

2234b

CIHR CAHR-43273

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Treatment

Experimental group

Description:

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

Treatment:

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

Control

Active Comparator group

Description:

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

Treatment:

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