Children With Developmental DelayNCT04385706
Joint Planning in Paediatric Rehabilitation
A study testing Applied Coaching Model in people with Children With Developmental Delay, run by Western University, Canada at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Children With Developmental Delay
- What is being tested?
- Applied Coaching Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Interventional
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Receiving care for developmental delay
Who cannot join
- Cannot speak or read english
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Children's Hospital - Early Childhood Rehabilitation
Calgary, Alberta, T3B6A8
About this study
Official title: 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.
- Conditions
- Children With Developmental Delay
- Being tested
- Applied Coaching Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Coaching ModelBehavioural
The Applied Coaching Model incorporates key learning opportunities and coaching strategies with evidence-based practices, approaches and theories and will serve as a tool for all healthcare providers wanting to implement coaching techniques within their practice.
| Study group | Role | What they receive |
|---|---|---|
| Applied Coaching Model | Experimental | One-group pre/post test Receives: Behavioral: Applied Coaching Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure (COPM)
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.
Measured: Change in COPM performance and satisfaction between baseline and 6-months.
Secondary outcomes (5)
Measure of Processes of Care (MPOC)
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.
Measured: Change in MPOC (satisfaction) between baseline and 6-months.
PedsQL Family Impact Module
Quality of life
Measured: Change in PedsQL Family Impact Module between baseline and 6-months
Parent Stress Index
Stress
Measured: Change in Parenting Stress Index between baseline and 6-months
Self-efficacy Visual Analog Scale
self efficacy rating of ability to carry out home exercises, 0-100mm line, higher equals more self-efficacy
Measured: Change in self-efficacy between baseline and 6-months
Therapist perceived parent efficacy Visual Analog Scale
Therapist rated parent efficacy rating of ability to carry out home exercises, 0-100mm line, higher equals more efficacy
Measured: Change in efficacy between baseline and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Sep 2020
- Primary completion30 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Developmental DelayStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group pre-test post-test design to evaluate a coaching model
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Brunton, Western University, Canada
- Investigators
- Laura K Brunton, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385706
- Sponsor's protocol ID
- 115539
- Status last verified
- Apr 2024
- First submitted
- 6 May 2020
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data can be requested from the PI and all requests will be considered on an individual basis
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Joint Planning in Paediatric Rehabilitation: Parent and Child Related Outcomes
- ClinicalTrials.gov ID
- NCT04385706
- Acronym / sponsor ID
- 115539
- Conditions
- Children With Developmental Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 May 2020 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group pre-test post-test design to evaluate a coaching model
| Arm | Type | Receives |
|---|---|---|
| Applied Coaching Model | Experimental | Behavioral: Applied Coaching ModelOne-group pre/post test |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Receiving care for developmental delay
Key exclusion criteria (1 listed)
- Cannot speak or read english
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 |
|---|---|---|
| Applied Coaching ModelThe Applied Coaching Model incorporates key learning opportunities and coaching strategies with evidence-based practices, approaches and theories and will serve as a tool for all healthcare providers wanting to implement coaching techniques within their practice. | Behavioural | Applied Coaching Model |
Primary outcome
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.
5 secondary outcomes
Measure of Processes of Care (MPOC)
Time frame: 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
Parent Stress Index
Time frame: 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
Therapist perceived parent efficacy Visual Analog Scale
Time frame: Change in efficacy between baseline and 6-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 29 Apr 2024.
- Individual participant dataSharing planned: No. Individual participant data can be requested from the PI and all requests will be considered on an individual basis
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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.
Laura K Brunton, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Coaching Model in people with Children With Developmental Delay, run by Western University, Canada 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 1 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 29 Apr 2024. 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.
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?
Change in Canadian Occupational Performance Measure (COPM) (time frame: Change in COPM performance and satisfaction between baseline and 6-months.). 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 29 Apr 2024.