Rehabilitation of Children With Multiple Disabilities
Primary Purpose
Cerebral Palsy, Autism, Down's Syndrome
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
CTN model of care for children and their families
Sponsored by
About this trial
This is an interventional health services research trial for Cerebral Palsy focused on measuring Children, Rehabilitation, Family Functioning, Mental Health, Costs, Integration
Eligibility Criteria
Inclusion Criteria:
- Children and youth up to 19 years of age
- living in Simcoe-York.
- English speaking
- multi-need family
- children on agency service wait lists
- children under the care of Children's Aid Societies
- Families with more than 1 disabled child
Exclusion Criteria:
-youth over 19 years.
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Parental reports of their children
Integration of service provider teams
Arm Description
Parental report of family-centered processes of care (MPOC) Parent mental health Parent perceived social support
Network co-alition teams were measured using the Integration of Human Services Measure, the Partnership Synergy Measure and a Network Capacity Measure were employed at the CEO level.
Outcomes
Primary Outcome Measures
Parental reports in the Quality of Life of Children and Youth
Parent report of family centred processes of care (MPOC) Parent mental health Parent perceived social support
Secondary Outcome Measures
Integration of teams amongst service providers. Integration was measured at two levels using the Integration of Human Services Measure.
The measure evaluates observed and expected depth of integration among service providers.
CEO or senior manager participation in the Network was measured.
Full Information
NCT ID
NCT01379443
First Posted
June 14, 2011
Last Updated
June 22, 2011
Sponsor
Children's Treatment Network
Collaborators
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT01379443
Brief Title
Rehabilitation of Children With Multiple Disabilities
Official Title
The Comparative Effect and Expense of More and Less Integration of Services That Provide Treatment and Rehabilitation for Children With Multiple Disabilities: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Children's Treatment Network
Collaborators
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to compare the usual care and treatment of children and youth (0-19 years) with multiple developmental delays and disabilities and their families in Simcoe York with a co-ordinated, navigated approach to care using the Children's Treatment Network (CTN) services.
Detailed Description
The Children's Treatment Network (CTN)links existing children's services rather than creating a new Centre. The purpose of the evaluation is to compare the effectiveness and efficiency of this service with the usual care that people receive. 500 Children will be randomized to receive either usual care (250) or the co-ordinated, navigated care from CTN (250). The primary question to be addressed is whether the more integrated CTN model of service improves family-centered services, parent mental health, parenting, family function and the quality of the child's life and the families resource needs as well as reduce expenditures for the families' use of all other health and social services compared to the outcomes of usual care alone. What children and families with what characteristics and circumstances most benefit from which approach to the treatment of childhood disability in Simcoe-York? At what cost?
Agencies providing services to children will be evaluated as to how effective their integration of teams are functioning, their partnership with each other and capacity building in the community.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Autism, Down's Syndrome, Brain Injury
Keywords
Children, Rehabilitation, Family Functioning, Mental Health, Costs, Integration
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parental reports of their children
Arm Type
Active Comparator
Arm Description
Parental report of family-centered processes of care (MPOC) Parent mental health Parent perceived social support
Arm Title
Integration of service provider teams
Arm Type
No Intervention
Arm Description
Network co-alition teams were measured using the Integration of Human Services Measure, the Partnership Synergy Measure and a Network Capacity Measure were employed at the CEO level.
Intervention Type
Other
Intervention Name(s)
CTN model of care for children and their families
Intervention Description
Parental reports on the quality of life of their children and service needs
Primary Outcome Measure Information:
Title
Parental reports in the Quality of Life of Children and Youth
Description
Parent report of family centred processes of care (MPOC) Parent mental health Parent perceived social support
Time Frame
12 and 24 month
Secondary Outcome Measure Information:
Title
Integration of teams amongst service providers. Integration was measured at two levels using the Integration of Human Services Measure.
Description
The measure evaluates observed and expected depth of integration among service providers.
CEO or senior manager participation in the Network was measured.
Time Frame
12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children and youth up to 19 years of age
living in Simcoe-York.
English speaking
multi-need family
children on agency service wait lists
children under the care of Children's Aid Societies
Families with more than 1 disabled child
Exclusion Criteria:
-youth over 19 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandy Thurston
Organizational Affiliation
Children's Treatment Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Rehabilitation of Children With Multiple Disabilities
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