Strongest Families Ontario (Formerly the Family Help Program)

Oppositional Defiant Disorder Clinical Trial

— SF-ON  

Official title:

Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473511
• Other study ID #: 4839
• Secondary ID: MCT-91030
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2011
• Last updated: September 1, 2016
• Start date: February 2010
• Est. completion date: December 2015

Study information

• Verified date: September 2016
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Strongest Families (formerly Family Help)is an evidence-based, distance health education model for families who have children with behavioural difficulties. The principal research question is "Does Strongest Families, a 12-week, home-based program of interactive readings, instructional videos, homework projects, and weekly "coaching" telephone calls out perform the care families typically experience when referred to a mental health service?". The investigators hypothesize that children randomized to Strongest Families intervention will show a significantly greater reduction in externalizing behaviour problems than those randomized to a Control (usual care). In addition, parents randomized to Family Help will report a greater improvement in parenting skills and a greater reduction in symptoms of emotional distress (i.e., feeling of anxiety, depression, and stress) than parents in the Control condition. Finally, families randomized to Family Help will use fewer mental health services than Controls.

Description:

Our project is designed to help families and children with mild or moderate symptoms early, before problems become worse and more difficult to treat.

The Strongest Families Program is a distance parenting program that was developed at the Centre for Research in Family Health at the IWK Health Centre in Halifax, Nova Scotia. Most families are able to manage these problems if they are given the skills to do so. The Strongest Families "Parenting the Active Child" Distance Program is done over the telephone; families do not have to travel to a centre to receive help. This program includes a handbook, videos and weekly phone calls between the parent and non-professional'coach'. The coach provides support to families, answer questions and guide parents as they learn the skills. Strongest Families has helped hundreds of families in Nova Scotia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

Male or female individuals who meet all the following criteria are eligible for this trial:

• Child is aged 6 to 12 years and

• Completed and signed referral form from a participating intake site is received and

• Parent/legal guardian provides verbal, telephone consent to participate and

• Ability of participant to read and understand English (at a Grade 5 level) and

• There must be the reasonable intention that for the study duration the child will remain in the direct care of the participant and at the same address as the participant (2 years) and o Child presents with significant levels of disruptive behaviour based on the BCFPI results at the referring agent end and clinical evaluation of the corroborative study assessment measures.

Exclusion Criteria:

Participants meeting one or more of the following criteria cannot be selected:

• Child is in the care of a child protective agency or currently being investigated by a child protective agency

• Child has received any form of behavioural treatment in the past 6 months

• Child is at an imminent risk of harm to themselves or others

• In the judgment of the investigator or delegate, any condition that may interfere with effective delivery of the study protocol/intervention program (i.e., High parental DASS-21 score, complex child symptomology, families who are unmotivated or are in complete chaos)

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
• Behaviour Disorder
• Disease
• Mental Disorders
• Oppositional Defiant Disorder

Intervention

Behavioral:
• Strongest Families Intervention (formerly Family Help)
Distance HEALTH education intervention focussed on skill learning for parents

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 (9)

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, Andreou P. Barriers to mental health care: perceived delivery system differences. ANS Adv Nurs Sci. 2013 Jan-Mar;36(1):51-61. doi: 10.1097/ANS.0b013e31828077eb. — 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. Development and initial validation of the treatment barrier index scale: a content validity study. ANS Adv Nurs Sci. 2011 Apr-Jun;34(2):151-62. doi: 10.1097/ANS.0b013e3182186cc0. — 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 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Behaviour Checklist	Results will be analyzed as change from baseline over time	Baseline, 5, 10, 16, 22 months	No
Secondary	Alabama Parenting questionnaire	Results will be analyzed as change from baseline over time	Baseline, 5, 10, 16, 22 months	No
Secondary	SCAPI (economic)	Results will be analyzed as change from baseline over time	Baseline,5, 10, 16, 22	No
Secondary	DASS-21	Results will be analyzed as change from baseline over time	Baseline,5, 10, 16, 22	No
Secondary	Investigator designed Satisfaction measure	Participant satisfaction with this psychological intervention will be measured at the end of intervention that varies between participants, but on average is about 5 months post-randomization	end of intervention	No
Secondary	Investigator designed disability measure	Results will be analyzed as change from baseline over time	weekly during intervention	No
Secondary	Discrete Conjoint Preference survey: Investigator designed	We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.	baseline, 5, 16 months	No