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

Primary Purpose

Pediatric Disruptive Behaviour Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Disruptive Behaviour Disorder

Eligibility Criteria

3 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment

Control

Arm Description

50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment

50% randomized to control group: standard/usual care for behaviour disorder

Outcomes

Primary Outcome Measures

Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.

Secondary Outcome Measures

Alabama Parenting Questionnaire
Revised Disruptive Disorder Rating Scale
Connors rating scale
Disability Measure;
Child Health Questionnaire
Economic Outcome assessment

Full Information

First Posted
December 19, 2005
Last Updated
March 27, 2013
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00267579
Brief Title
Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder
Official Title
Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
April 2008 (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
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Disruptive Behaviour Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment
Arm Title
Control
Arm Type
Active Comparator
Arm Description
50% randomized to control group: standard/usual care for behaviour disorder
Intervention Type
Behavioral
Intervention Name(s)
Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Other Intervention Name(s)
Strongest Families (formerly Family Help Program):
Intervention Description
Evidence-based psychological and behavioural Distance Intervention
Primary Outcome Measure Information:
Title
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Time Frame
baseline, 120, 240 and 365 day follow-up
Secondary Outcome Measure Information:
Title
Alabama Parenting Questionnaire
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Revised Disruptive Disorder Rating Scale
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Connors rating scale
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Disability Measure;
Time Frame
Weekly during treatment; baseline, 120, 240 and 365 day follow-up
Title
Child Health Questionnaire
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Economic Outcome assessment
Time Frame
baseline, 120, 240 and 365 day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. McGrath, PhD.
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

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
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
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
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
result
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
result
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
result

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

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