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

December 19, 2005
September 11, 2013
August 2003
September 2007   (final data collection date for primary outcome measure)
Diagnosis using KSADS [ Time Frame: baseline, 120, 240 and 365 day follow-up. ] [ Designated as safety issue: No ]
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Complete list of historical versions of study NCT00267566 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Symptomology frequency as evidenced by diary data;
  • Anxiety specific measure (MASC- self-report);
  • Disability Measure;
  • Child Health Questionnaire
  • Economic Outcome assessment
  • gathered at baseline, 120, 240 and 365 day follow-up.
Not Provided
Not Provided
 
Strongest Families (Formerly Family Help Program): Pediatric Anxiety
Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Anxiety Disorder
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: Treatment
    50% random assignment to receive Family Help Anxiety Treatment
    Intervention: Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program
  • Experimental: Control
    50% random assignment to control group to receive usual/standard care for anxiety
    Intervention: Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
April 2008
September 2007   (final data collection date for primary outcome measure)

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
Both
6 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00267566
2234a, CIHR CAHR-43273
No
IWK Health Centre
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Patrick J McGrath, PhD. IWK Health Centre
IWK Health Centre
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP