search
Back to results

Strongest Families Ontario (Formerly the Family Help Program) (SF-ON)

Primary Purpose

Oppositional Defiant Disorder, Behaviour Disorder

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Strongest Families Intervention (formerly Family Help)
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring Behavioural intervention, Distance intervention, Parenting intervention

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Strongest Families Program + Usual care

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child Behaviour Checklist
Results will be analyzed as change from baseline over time

Secondary Outcome Measures

Alabama Parenting questionnaire
Results will be analyzed as change from baseline over time
SCAPI (economic)
Results will be analyzed as change from baseline over time
DASS-21
Results will be analyzed as change from baseline over time
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
Investigator designed disability measure
Results will be analyzed as change from baseline over time
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.

Full Information

First Posted
July 22, 2011
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT01473511
Brief Title
Strongest Families Ontario (Formerly the Family Help Program)
Acronym
SF-ON
Official Title
Delivering Intervention for Pediatric Behaviour Problems at a Distance: a Randomized Trial of Strongest Families Ontario
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Behaviour Disorder
Keywords
Behavioural intervention, Distance intervention, Parenting intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strongest Families Program + Usual care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strongest Families Intervention (formerly Family Help)
Other Intervention Name(s)
formerly the Family Help Program
Intervention Description
Distance HEALTH education intervention focussed on skill learning for parents
Primary Outcome Measure Information:
Title
Child Behaviour Checklist
Description
Results will be analyzed as change from baseline over time
Time Frame
Baseline, 5, 10, 16, 22 months
Secondary Outcome Measure Information:
Title
Alabama Parenting questionnaire
Description
Results will be analyzed as change from baseline over time
Time Frame
Baseline, 5, 10, 16, 22 months
Title
SCAPI (economic)
Description
Results will be analyzed as change from baseline over time
Time Frame
Baseline,5, 10, 16, 22
Title
DASS-21
Description
Results will be analyzed as change from baseline over time
Time Frame
Baseline,5, 10, 16, 22
Title
Investigator designed Satisfaction measure
Description
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
Time Frame
end of intervention
Title
Investigator designed disability measure
Description
Results will be analyzed as change from baseline over time
Time Frame
weekly during intervention
Title
Discrete Conjoint Preference survey: Investigator designed
Description
We will examine if discrete choice data collected at baseline predicts participation, adherence and outcome. We will also explore changes in preferences over time.
Time Frame
baseline, 5, 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J McGrath, PhD
Organizational Affiliation
Vice President of REsearch Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate summary data would be made available but not individual data.
Citations:
PubMed Identifier
17227604
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.
Results Reference
background
PubMed Identifier
18632994
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.
Results Reference
background
PubMed Identifier
18025870
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.
Results Reference
background
PubMed Identifier
18632997
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.
Results Reference
background
PubMed Identifier
21572262
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.
Results Reference
background
PubMed Identifier
19270846
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.
Results Reference
background
PubMed Identifier
22024004
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.
Results Reference
background
PubMed Identifier
22170209
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.
Results Reference
background
PubMed Identifier
23370500
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.
Results Reference
background

Learn more about this trial

Strongest Families Ontario (Formerly the Family Help Program)

We'll reach out to this number within 24 hrs