Strongest Families Ontario (Formerly the Family Help Program)

NCT ID: NCT01473511

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Oppositional Defiant Disorder Behaviour Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Strongest Families Program + Usual care

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.

Group Type EXPERIMENTAL

Strongest Families Intervention (formerly Family Help)

Intervention Type BEHAVIORAL

Distance HEALTH education intervention focussed on skill learning for parents

Usual care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Strongest Families Intervention (formerly Family Help)

Distance HEALTH education intervention focussed on skill learning for parents

Intervention Type BEHAVIORAL

Other Intervention Names

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formerly the Family Help Program

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick J McGrath, PhD

Role: PRINCIPAL_INVESTIGATOR

Vice President of REsearch Services

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 17227604 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18632994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18025870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18632997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21572262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19270846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22024004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22170209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23370500 (View on PubMed)

Other Identifiers

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MCT-91030

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4839

Identifier Type: -

Identifier Source: org_study_id

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