Strongest Families (Formerly Family Help Program): Pediatric Anxiety (FHP-ANX)

IWK Health Centre

Status and phase: Completed; Phase 2

Conditions: Anxiety Disorder

Treatments: Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program

Study type: Interventional

Funder types: Other

Identifiers

NCT00267566

2234a

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 Anxiety symptomology. This is a single-center trial based at the IWK Health Center. 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 128 children (6-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric anxiety 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 Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.

Enrollment: 91 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• child 6 to 12 years of age
• child had Anxiety symptoms for 6 months or longer
• access to a telephone in the home
• speak and write english
• mild to moderate anxiety symptomology

Exclusion criteria

• severe anxiety symptomology
• received similar intervention within past 6 months
• excessive anxiety following a significant traumatic event

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Treatment

Experimental group

Description:

50% random assignment to receive Family Help Anxiety Treatment

Treatment:

Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program

Control

Experimental group

Description:

50% random assignment to control group to receive usual/standard care for anxiety

Treatment:

Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program