Strongest Families Ontario (Formerly the Family Help Program)

NCT01473511 | Completed Phase 3 DMC

• 2 other identifiers: 4839MCT-91030
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oppositional Defiant Disorder; Behaviour Disorder

Keywords

Behavioural intervention; Distance intervention; Parenting intervention

Outcome Measures

Primary Outcomes (1)

• Child Behaviour Checklist

  Results will be analyzed as change from baseline over time

  Baseline, 5, 10, 16, 22 months

Secondary Outcomes (6)

• Alabama Parenting questionnaire

  Baseline, 5, 10, 16, 22 months

• SCAPI (economic)

  Baseline,5, 10, 16, 22

• DASS-21

  Baseline,5, 10, 16, 22

• Investigator designed Satisfaction measure

  end of intervention

• Investigator designed disability measure

  weekly during intervention

Study Arms (2)

Strongest Families Program + Usual care

EXPERIMENTAL

50% randomized to receive Strongest Families intervention immediately as well as the usual care services available via the referring agency for the 22 month study period.

Behavioral: Strongest Families Intervention (formerly Family Help)

Usual care

NO INTERVENTION

50% randomized will not receive Strongest Families Intervention during the 22 month study phase, but will receive the usual care services available via the referring agency. At the end of the 22 month study period study participants will be offered the Strongest Families Intervention services.

Interventions

Strongest Families Intervention (formerly Family Help) BEHAVIORAL

Distance HEALTH education intervention focussed on skill learning for parents

Also known as: formerly the Family Help Program

Strongest Families Program + Usual care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

Related 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. doi: 10.1258/135763306779378690.

  PMID: 17227604 BACKGROUND

• 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.

  PMID: 18632994 BACKGROUND

• 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.

  PMID: 18025870 BACKGROUND

• 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.

  PMID: 18632997 BACKGROUND

• 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.

  PMID: 21572262 BACKGROUND

• 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.

  PMID: 19270846 BACKGROUND

• 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.

  PMID: 22024004 BACKGROUND

• 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.

  PMID: 22170209 BACKGROUND

• 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.

  PMID: 23370500 BACKGROUND

MeSH Terms

Conditions

Oppositional Defiant Disorder; Mental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Patrick J McGrath, PhD

  Vice President of REsearch Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2011
• First Posted: November 17, 2011
• Study Start: February 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)