- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385706
Joint Planning in Paediatric Rehabilitation
July 13, 2022 updated by: Laura Brunton, Western University, Canada
The Effectiveness of Joint Planning in Paediatric Rehabilitation: Parent and Child Related Outcomes
We will use one group, pretest-posttest research design.
The intervention will have a 6-month timeframe.
Up to 18 participants will be selected from active caseloads of the three to six participating healthcare providers in the Early Childhood Rehabilitation Program at the Alberta Children's Hospital, Child Development Centre site in Calgary Alberta.
All data will be collected in Alberta using remote measures.
Parents and therapists will complete surveys in an online portal.
One measure needs to be completed in conjunction with the therapist and parent and will be done in person using an online portal.
The researchers will have a local investigator (Debra Teitelbaum) in Calgary who works on-site to help manage data collection and recruitment in person if necessary.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T3B6A8
- Alberta Children's Hospital - Early Childhood Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Receiving care for developmental delay
Exclusion Criteria:
- Cannot speak or read english
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Canadian Occupational Performance Measure (COPM)
Time Frame: Change in COPM performance and satisfaction between baseline and 6-months.
|
An evidence-based measure designed to capture a client's/familie's self-perception of performance in everyday living, their satisfaction with their performance, and changes in performance/satisfaction over time.
It is one method of setting and measuring achievement of individualized therapeutic goals.
|
Change in COPM performance and satisfaction between baseline and 6-months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of Processes of Care (MPOC)
Time Frame: Change in MPOC (satisfaction) between baseline and 6-months.
|
Satisfaction with healthcare services - the MPOC is a self-report measure of parents' perceptions of the extent to which the health services they and their child(ren) receive are family-centred.
|
Change in MPOC (satisfaction) between baseline and 6-months.
|
PedsQL Family Impact Module
Time Frame: Change in PedsQL Family Impact Module between baseline and 6-months
|
Quality of life
|
Change in PedsQL Family Impact Module between baseline and 6-months
|
Parent Stress Index
Time Frame: Change in Parenting Stress Index between baseline and 6-months
|
Stress
|
Change in Parenting Stress Index between baseline and 6-months
|
Self-efficacy Visual Analog Scale
Time Frame: Change in self-efficacy between baseline and 6-months
|
self efficacy rating of ability to carry out home exercises, 0-100mm line, higher equals more self-efficacy
|
Change in self-efficacy between baseline and 6-months
|
Therapist perceived parent efficacy Visual Analog Scale
Time Frame: Change in efficacy between baseline and 6-months
|
Therapist rated parent efficacy rating of ability to carry out home exercises, 0-100mm line, higher equals more efficacy
|
Change in efficacy between baseline and 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura K Brunton, PhD, Western University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
May 6, 2020
First Submitted That Met QC Criteria
May 8, 2020
First Posted (Actual)
May 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 18, 2022
Last Update Submitted That Met QC Criteria
July 13, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 115539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual participant data can be requested from the PI and all requests will be considered on an individual basis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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