Skip to main content
OpenTrials
Completed

NCT Number: NCT00267566

Strongest Families (Formerly Family Help Program): Pediatric Anxiety

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strongest Families (formerly Family Help Program): Anxiety Program

Behavioral

Evidence-based psychological and behavioural distance intervention

Other names: Strongest Families (formerly Family Help Program)

Primary outcomes

  1. Diagnosis using KSADS

    Time frame: baseline, 120, 240 and 365 day follow-up.

Secondary outcomes

  1. Symptomology frequency as evidenced by diary data;

    Time frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization

  2. Anxiety specific measure (MASC- self-report);

    Time frame: baseline, 120, 240 and 365 day follow-up

  3. Disability Measure;

    Time frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up

  4. Child Health Questionnaire

    Time frame: baseline, 120, 240 and 365 day follow-up

  5. Economic Outcome assessment

    Time frame: baseline, 120, 240 and 365 day follow-up

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Anxiety)

Acronym: FHP-ANX

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Dec 21, 2005
Registry last updated
Sep 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.