Clinical trial NCT00267566: Strongest Families (Formerly Family Help Program): Pediatric Anxiety
Official title: Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Anxiety)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorder
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-12-21
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Diagnosis using KSADS
timeFrame: baseline, 120, 240 and 365 day follow-up.
Secondary outcomes:
measure: Symptomology frequency as evidenced by diary data;
timeFrame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
measure: Anxiety specific measure (MASC- self-report);
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Disability Measure;
timeFrame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
measure: Child Health Questionnaire
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Economic Outcome assessment
timeFrame: baseline, 120, 240 and 365 day follow-up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick J McGrath, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.