Rehabilitation of Children With Multiple Disabilities

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379443
• Other study ID #: 2008H00766
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2011
• Last updated: June 22, 2011
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2011
• Source: Children's Treatment Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Autism
• Brain Injury
• Cerebral Palsy
• Down Syndrome
• Down's Syndrome

Intervention

Other:
• CTN model of care for children and their families
Parental reports on the quality of life of their children and service needs

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Children's Treatment Network	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 and 24 month	No
Secondary	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.	12 months and 24 months	No