- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379443
Rehabilitation of Children With Multiple Disabilities
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Parental reports of their children
Parental report of family-centered processes of care (MPOC) Parent mental health Parent perceived social support
|
Parental reports on the quality of life of their children and service needs
|
|
No Intervention: Integration of service provider teams
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental reports in the Quality of Life of Children and Youth
Time Frame: 12 and 24 month
|
Parent report of family centred processes of care (MPOC) Parent mental health Parent perceived social support
|
12 and 24 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Integration of teams amongst service providers. Integration was measured at two levels using the Integration of Human Services Measure.
Time Frame: 12 months and 24 months
|
The measure evaluates observed and expected depth of integration among service providers. CEO or senior manager participation in the Network was measured. |
12 months and 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sandy Thurston, Children's Treatment Network
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Brain Damage, Chronic
- Genetic Diseases, Inborn
- Craniocerebral Trauma
- Trauma, Nervous System
- Intellectual Disability
- Abnormalities, Multiple
- Chromosome Disorders
- Cerebral Palsy
- Brain Injuries
- Down Syndrome
Other Study ID Numbers
- 2008H00766
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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