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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00267566
First received: December 19, 2005
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Anxiety Disorder
Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Anxiety)

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Diagnosis using KSADS [ Time Frame: baseline, 120, 240 and 365 day follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ] [ Designated as safety issue: No ]
  • Anxiety specific measure (MASC- self-report); [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Disability Measure; [ Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: August 2003
Study Completion Date: April 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
50% random assignment to receive Family Help Anxiety Treatment
Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program
Evidence-based psychological and behavioural distance intervention
Other Name: Strongest Families (formerly Family Help Program)
Experimental: Control
50% random assignment to control group to receive usual/standard care for anxiety
Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program
Evidence-based psychological and behavioural distance intervention
Other Name: Strongest Families (formerly Family Help Program)

Detailed 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267566

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J McGrath, PhD. IWK Health Centre
  More Information

Additional Information:
Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00267566     History of Changes
Other Study ID Numbers: 2234a, CIHR CAHR-43273
Study First Received: December 19, 2005
Last Updated: September 11, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014