Strongest Families (Formerly Family Help Program): Pediatric Anxiety (FHP-ANX)
September 11, 2013 updated by: IWK Health Centre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
50% random assignment to receive Family Help Anxiety Treatment
|
Evidence-based psychological and behavioural distance intervention
Other Names:
|
|
Experimental: Control
50% random assignment to control group to receive usual/standard care for anxiety
|
Evidence-based psychological and behavioural distance intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diagnosis using KSADS
Time Frame: baseline, 120, 240 and 365 day follow-up.
|
baseline, 120, 240 and 365 day follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child Health Questionnaire
Time Frame: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
|
Economic Outcome assessment
Time Frame: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
|
Symptomology frequency as evidenced by diary data;
Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
|
daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
|
|
Disability Measure;
Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
|
weekly during treatment; baseline, 120, 240 and 365 day follow-up
|
|
Anxiety specific measure (MASC- self-report);
Time Frame: baseline, 120, 240 and 365 day follow-up
|
baseline, 120, 240 and 365 day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Patrick J McGrath, PhD., IWK Health Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
- Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
- McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
- McGrath PJ, Lingley-Pottie P, Thurston C, MacLean C, Cunningham C, Waschbusch DA, Watters C, Stewart S, Bagnell A, Santor D, Chaplin W. Telephone-based mental health interventions for child disruptive behavior or anxiety disorders: randomized trials and overall analysis. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1162-72. doi: 10.1016/j.jaac.2011.07.013. Epub 2011 Sep 3.
- Lingley-Pottie P, Janz T, McGrath PJ, Cunningham C, MacLean C. Outcome progress letter types: parent and physician preferences for letters from pediatric mental health services. Can Fam Physician. 2011 Dec;57(12):e473-81.
- Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
- Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 19, 2005
First Submitted That Met QC Criteria
December 19, 2005
First Posted (Estimate)
December 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 12, 2013
Last Update Submitted That Met QC Criteria
September 11, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2234a
- CIHR CAHR-43273 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.