Cerebral PalsyPhase 1NCT01379443
Rehabilitation of Children With Multiple Disabilities
A Phase 1 study testing CTN model of care for children and their families in people with Cerebral Palsy and Autism, run by Children's Treatment Network at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 19 years
- Conditions the study is for
- Cerebral Palsy, Autism, Down's Syndrome
- What is being tested?
- CTN model of care for children and their families
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- -youth over 19 years.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy, Autism, Down's Syndrome, Brain Injury
- Being tested
- CTN model of care for children and their families
- Keywords
- Children, Rehabilitation, Family Functioning, Mental Health, Costs, Integration
- Medical subject headings
- Cerebral Palsy, Autistic Disorder, Down Syndrome, Brain Injuries, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTN model of care for children and their familiesOther
Parental reports on the quality of life of their children and service needs
| Study group | Role | What they receive |
|---|---|---|
| Parental reports of their children | Active comparator | Parental report of family-centered processes of care (MPOC) Parent mental health Parent perceived social support Receives: Other: CTN model of care for children and their families |
| Integration of service provider teams | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 and 24 month
Secondary outcomes (1)
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.
Measured: 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startApr 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Treatment Network
- Sponsor type
- Research network
- Collaborators
- McMaster University
- Investigators
- Sandy Thurston, Principal investigator, Children's Treatment Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379443
- Sponsor's protocol ID
- 2008H00766
- Status last verified
- Jun 2011
- First submitted
- 14 Jun 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01379443
- Acronym / sponsor ID
- 2008H00766
- Conditions
- Cerebral Palsy, Autism, Down's Syndrome, Brain Injury
- Keywords
- Children, Rehabilitation, Family Functioning, Mental Health, Costs, Integration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Children's Treatment NetworkResearch network
- Collaborators
- McMaster University
- Study start
- Apr 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parental reports of their children | Active comparator | Other: CTN model of care for children and their familiesParental report of family-centered processes of care (MPOC) Parent mental health Parent perceived social support |
| Integration of service provider teams | No intervention | –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. |
Who may qualify
- Ages
- 1 minute to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Children and youth up to 19 years of age
- living in Simcoe-York.
- English speaking
- multi-need family
- children on agency service wait lists
Key exclusion criteria (1 listed)
- -youth over 19 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTN model of care for children and their familiesParental reports on the quality of life of their children and service needs | Other | Parental reports of their children |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandy Thurston principal investigator
Children's Treatment Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTN model of care for children and their families in people with Cerebral Palsy and Autism, run by Children's Treatment Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental reports in the Quality of Life of Children and Youth (time frame: 12 and 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.