Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder

Pediatric Disruptive Behaviour Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267579
• Other study ID #: 2234b
• Secondary ID: CIHR CAHR-43273
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2005
• Last updated: March 27, 2013
• Start date: October 2003
• Est. completion date: April 2008

Study information

• Verified date: March 2013
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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 Disruptive Behaviour symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

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 60 children (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior disorder 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 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 Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• child 3 to 7 years of age

• child had behavioural problems for 6 months or longer

• access to a telephone in the home

• speak and write english

• mild to moderate disruptive behaviour symptomology

Exclusion Criteria:

• severe disruptive behaviour symptomology

• received similar intervention within past 6 months

• Autism or Schizophrenia

• child has intellectual impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Mental Disorders
• Pediatric Disruptive Behaviour Disorder

Intervention

Behavioral:
• Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Evidence-based psychological and behavioural Distance Intervention

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. — View 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. — View 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. — View Citation

Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. — View 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. Review. — View 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. — View 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.		baseline, 120, 240 and 365 day follow-up	No
Secondary	Alabama Parenting Questionnaire		baseline, 120, 240 and 365 day follow-up	No
Secondary	Revised Disruptive Disorder Rating Scale		baseline, 120, 240 and 365 day follow-up	No
Secondary	Connors rating scale		baseline, 120, 240 and 365 day follow-up	No
Secondary	Disability Measure;		Weekly during treatment; baseline, 120, 240 and 365 day follow-up	No
Secondary	Child Health Questionnaire		baseline, 120, 240 and 365 day follow-up	No
Secondary	Economic Outcome assessment		baseline, 120, 240 and 365 day follow-up	No