Spina BifidaCATCHNCT03523806
Children and Teens in Charge of Their Health
A study testing Solution-Focused Coaching in Pediatric Rehabilitation in people with Spina Bifida and Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
Trial summary
This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Spina Bifida, Cerebral Palsy, Health Behavior
- What is being tested?
- Solution-Focused Coaching in Pediatric Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Mar 2018to 31 Mar 2023
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Child Inclusion Criteria:
- Between the age of 10 - 18 years inclusive
- Diagnosis of SB or CP
- Has physical capability to execute independent body movement with or without device
- Cognitively able and willing to set PA or dietary goals
- Can communicate in English and respond to questions requiring some reflection and insight
- Home internet connection
- Lives within 2 hours driving distance from Toronto up to London, Ontario OR willing to travel to either HB or TVCC for first in-person coaching session if randomized into coaching group
Child exclusion criteria:
- Surgery in past 6 months or upcoming 12 months that may impact PA or dietary intake (e.g. orthopedic surgery or neurosurgery)
- Medical condition severely restricting diet
- Underweight (less than fifth percentile)
- Receiving specialist dietetic services
Parent inclusion criteria:
- Primary caregiver to a study participant
- Can communicate in English and respond to questions requiring some reflection and insight
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Thames Valley Children's Centre
London, Ontario, N6C 5Y6
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
About this study
Official title: Children and Teens in Charge of Their Health: A Feasibility Study of Solution-focused Coaching to Foster Healthy Lifestyles in Children and Young People With Physical Disabilities
This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD).
Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care and basic printed information about healthy lifestyles. In addition, 15 will receive a coaching intervention for the first six months. Pre-defined success criteria will assess the feasibility of trial processes.
Acceptability of trial participation and impact of coaching will be explored qualitatively. Health indicators and psychosocial outcomes will be assessed four times, at the start of the trial, immediately post-intervention and at three and six months post-intervention.
Read the detailed description
The World Health Organization's Global Strategy on Diet, Physical Activity (PA) and Health Promotion highlights that PA and dietary habits are central to disease prevention and lifelong health. Canadian children have increased health risks as their activity levels are drastically lower than recommendations and ~26% are classified as overweight or obese. The situation is even more critical for children with disabilities; 4.2% of Canadian children have disabilities and this number is rising. Due to complex and intersecting factors, children with physical disabilities (CWPD) are more sedentary, have lower PA rates and poorer quality diets than their non-disabled peers. Annual health care costs of obesity related to disability are estimated at $44 billion in the US, supporting the need to start health promotion activities early in life. Despite the serious proximal and distal consequences of this health profile, the investigators lack robust evidence on effective strategies to foster and sustain health habits for CWPD.
A new intervention paradigm that produces sustainable results without undue burden (on families or services) is therefore urgently required to address the health promotion needs of CWPD. The investigators propose that a strengths-based coaching approach may meet all of these requirements. Solution-Focused Coaching in Pediatric Rehabilitation (SFC-Peds) has been recommended as a coaching model for children with disabilities, for its strong theoretical basis and ability to be customized to children and families' resources, environmental settings, child age and developmental stage. Taking a strengths-based approach (such as SFC-Peds) is a departure from usual rehabilitation research and practice, which has largely been problem-focused (i.e. what a child can't do). A strengths-based approach can result in hope, motivation and action.
Given that the investigators will be the first to use SFC-Peds to promote healthy habits with CWPD, a feasibility and acceptability study is essential. Evidence of feasibility is a critical prerequisite for a RCT, especially for complex interventions that have multiple interacting components and/or target multiple behaviours (such as SFC-Peds). Feasibility studies rigorously examine the processes (e.g. recruitment and retention), resources (e.g. personnel, time required to complete measures), management (e.g. coordination of research personnel, quality of data entry) and science (e.g. appropriate methodology and outcomes) of the intended RCT. It is also critical to evaluate the acceptability of interventions for the target population (e.g. satisfaction with duration, intensity, level of interest, perceived impact), as well as those allocated to the control arm (e.g. acceptability of not receiving coaching, perceived burden of assessments). Examining all of these issues before the efficacy trial begins increases the likelihood of success. Feasibility studies such as the one the investigators are proposing help ensure that resources are invested in efficacy trials likely to generate clinically meaningful results and therefore have maximum impact on health care knowledge and outcomes.
Primary objective: To evaluate the feasibility (study design, methods, processes) and acceptability (family/child/clinician satisfaction, perceived usefulness) of conducting a randomized controlled trial (RCT) of a novel, brief, coaching intervention, solution-focused coaching in pediatric rehabilitation (SFC-Peds) for improving and sustaining physical activity (PA) and dietary habits in children with physical disabilities (CWPD).
Secondary objective: To determine the responsiveness of selected outcome measures to SFC-Peds coaching over 12 months.
Principal research question: "Is an efficacy trial to evaluate a 6 month SFC-Peds intervention to improve PA and dietary habits feasible to implement and acceptable to CWPD and families?"
Physical, environmental and psychosocial restrictions mean that children with physical disabilities (CWPD) are adopting worrying physical activity (PA) and dietary habits. Despite this, the investigators currently have limited evidence to inform interventions that may enhance lifelong health in CWPD. The investigators suggest that a paradigm shift is needed, one that moves beyond traditional prescriptive programs to a strengths-based approach where intervention strategies enable new health habits to be integrated seamlessly into children and families' everyday lifestyles for long-term sustainability.
Research such as our proposed study will ensure that this potentially transformative approach is rigorously examined and used in an evidence-based manner. As little is known about effective and acceptable behaviour change interventions for CWPD, this study's findings will make significant contributions to the field: i) Greater understanding of ecologically valid interventions that have the potential to enhance the long term health of CWPD; ii) Insight into how 2 different rehabilitation populations respond to SFC-Peds; and iii) Data on the responsiveness of outcome measures to a SFC-Peds intervention. These insights will enable us to design acceptable, feasible and rigorous interventions that will result in robust data for informing both research and clinical practice.
- Conditions
- Spina Bifida, Cerebral Palsy, Health Behavior
- Being tested
- Solution-Focused Coaching in Pediatric Rehabilitation
- Medical subject headings
- Spinal Dysraphism, Cerebral Palsy, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution-Focused Coaching in Pediatric RehabilitationBehavioural
A coaching model for children with disabilities, with a strong theoretical basis, and ability to be customized to children and families' resources, environmental settings, child age and developmental stage
| Study group | Role | What they receive |
|---|---|---|
| Solution-Focused Coaching Group | Experimental | Half of the participants (n=15) will be assigned a coach and receive coaching 8 times for up to 1 hour over 6 months. The first session will take place in the home and subsequent session will take place online using an online meeting tool. Receives: Behavioral: Solution-Focused Coaching in Pediatric Rehabilitation |
| Control Group | No intervention | Half of the participants (n=15) will not be receiving coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Canadian Occupational Performance Measure (COPM) scores
The COPM is an evidence-based outcome measure designed to capture a participant's self-perception of performance in everyday living, over time.
Participants will identify occupational performance problems in the areas of SELF-CARE (personal care, functional mobility, and community management), PRODUCTIVITY (paid or unpaid work, household management, and school and/or play), and LEISURE (quiet recreation, active recreation, and socialization).
They will then rate each one in terms of its IMPORTANCE in their life on a scale of 1 (not important at all) to 10 (extremely important). Respondents will pick 5 problems and for each problem rate:
PERFORMANCE (how would you rate the way that you do this activity now?) on a scale of 1 (not able to do it at all) to 10 (able to do it extremely well) SATISFACTION (How satisfied are you with the way you do this activity now?) on a scale of 1 (not satisfied at all) to 10 (extremely satisfied).
Measured: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
Secondary outcomes (1)
Change Goal Attainment Scaling (GAS) scores
A measure of participant goal attainment by defining five levels of goal attainment, thus ensuring that all attainment levels are mutually exclusive and measurable. This is an objective measure of behaviour change. Participants will provide a goal statement for each level.
Scale ranges from:
- 2 present level or much less than expected
- 1 somewhat less than expected 0 expected level or program goal
- 1 somewhat better than expected
- 2 much better than expected A single GAS score is identified for a goal from the above 5 levels. Higher scores indicate better goal attainment.
Measured: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start23 Mar 2018
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spina BifidaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Sponsor
- Investigators
- Amy McPherson, PhD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523806
- Sponsor's protocol ID
- CATCH-17-752
- Acronym
- CATCH
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McPherson AC, Biddiss E, Chen L, Church PT, de Groot JF, Keenan S, King G, Lui T, Maltais DB, Merette C, Moffet H, Moola F, Schwellnus H. Children and Teens in Charge of their Health (CATCH): A protocol for a feasibility randomised controlled trial of solution-focused coaching to foster healthy lifestyles in childhood disability. BMJ Open. 2019 Mar 4;9(3):e025119. doi: 10.1136/bmjopen-2018-025119.
PubMed 30837255
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Teens in Charge of Their Health: A Feasibility Study of Solution-focused Coaching to Foster Healthy Lifestyles in Children and Young People With Physical Disabilities
- ClinicalTrials.gov ID
- NCT03523806
- Acronym / sponsor ID
- CATCH / CATCH-17-752
- Conditions
- Spina Bifida, Cerebral Palsy, Health Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 14 May 2018 (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.
This three year study explores the feasibility and acceptability of conducting a full randomized controlled trial (RCT) of a promising coaching intervention for improving and sustaining physical activity (PA) and healthy dietary habits in children with physical disabilities (CWPD).
Thirty children (ages 10 - 18) will spend 12 months in the study. All will receive usual care and basic printed information about healthy lifestyles. In addition, 15 will receive a coaching intervention for the first six months. Pre-defined success criteria will assess the feasibility of trial processes.
Acceptability of trial participation and impact of coaching will be explored qualitatively. Health indicators and psychosocial outcomes will be assessed four times, at the start of the trial, immediately post-intervention and at three and six months post-intervention.
Detailed description
The World Health Organization's Global Strategy on Diet, Physical Activity (PA) and Health Promotion highlights that PA and dietary habits are central to disease prevention and lifelong health. Canadian children have increased health risks as their activity levels are drastically lower than recommendations and ~26% are classified as overweight or obese. The situation is even more critical for children with disabilities; 4.2% of Canadian children have disabilities and this number is rising. Due to complex and intersecting factors, children with physical disabilities (CWPD) are more sedentary, have lower PA rates and poorer quality diets than their non-disabled peers. Annual health care costs of obesity related to disability are estimated at $44 billion in the US, supporting the need to start health promotion activities early in life. Despite the serious proximal and distal consequences of this health profile, the investigators lack robust evidence on effective strategies to foster and sustain health habits for CWPD.
A new intervention paradigm that produces sustainable results without undue burden (on families or services) is therefore urgently required to address the health promotion needs of CWPD. The investigators propose that a strengths-based coaching approach may meet all of these requirements. Solution-Focused Coaching in Pediatric Rehabilitation (SFC-Peds) has been recommended as a coaching model for children with disabilities, for its strong theoretical basis and ability to be customized to children and families' resources, environmental settings, child age and developmental stage. Taking a strengths-based approach (such as SFC-Peds) is a departure from usual rehabilitation research and practice, which has largely been problem-focused (i.e. what a child can't do). A strengths-based approach can result in hope, motivation and action.
Given that the investigators will be the first to use SFC-Peds to promote healthy habits with CWPD, a feasibility and acceptability study is essential. Evidence of feasibility is a critical prerequisite for a RCT, especially for complex interventions that have multiple interacting components and/or target multiple behaviours (such as SFC-Peds). Feasibility studies rigorously examine the processes (e.g. recruitment and retention), resources (e.g. personnel, time required to complete measures), management (e.g. coordination of research personnel, quality of data entry) and science (e.g. appropriate methodology and outcomes) of the intended RCT. It is also critical to evaluate the acceptability of interventions for the target population (e.g. satisfaction with duration, intensity, level of interest, perceived impact), as well as those allocated to the control arm (e.g. acceptability of not receiving coaching, perceived burden of assessments). Examining all of these issues before the efficacy trial begins increases the likelihood of success. Feasibility studies such as the one the investigators are proposing help ensure that resources are invested in efficacy trials likely to generate clinically meaningful results and therefore have maximum impact on health care knowledge and outcomes.
Primary objective: To evaluate the feasibility (study design, methods, processes) and acceptability (family/child/clinician satisfaction, perceived usefulness) of conducting a randomized controlled trial (RCT) of a novel, brief, coaching intervention, solution-focused coaching in pediatric rehabilitation (SFC-Peds) for improving and sustaining physical activity (PA) and dietary habits in children with physical disabilities (CWPD).
Secondary objective: To determine the responsiveness of selected outcome measures to SFC-Peds coaching over 12 months.
Principal research question: "Is an efficacy trial to evaluate a 6 month SFC-Peds intervention to improve PA and dietary habits feasible to implement and acceptable to CWPD and families?"
Physical, environmental and psychosocial restrictions mean that children with physical disabilities (CWPD) are adopting worrying physical activity (PA) and dietary habits. Despite this, the investigators currently have limited evidence to inform interventions that may enhance lifelong health in CWPD. The investigators suggest that a paradigm shift is needed, one that moves beyond traditional prescriptive programs to a strengths-based approach where intervention strategies enable new health habits to be integrated seamlessly into children and families' everyday lifestyles for long-term sustainability.
Research such as our proposed study will ensure that this potentially transformative approach is rigorously examined and used in an evidence-based manner. As little is known about effective and acceptable behaviour change interventions for CWPD, this study's findings will make significant contributions to the field: i) Greater understanding of ecologically valid interventions that have the potential to enhance the long term health of CWPD; ii) Insight into how 2 different rehabilitation populations respond to SFC-Peds; and iii) Data on the responsiveness of outcome measures to a SFC-Peds intervention. These insights will enable us to design acceptable, feasible and rigorous interventions that will result in robust data for informing both research and clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solution-Focused Coaching Group | Experimental | Behavioral: Solution-Focused Coaching in Pediatric RehabilitationHalf of the participants (n=15) will be assigned a coach and receive coaching 8 times for up to 1 hour over 6 months. The first session will take place in the home and subsequent session will take place online using an online meeting tool. |
| Control Group | No intervention | –Half of the participants (n=15) will not be receiving coaching |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Solution-Focused Coaching in Pediatric RehabilitationA coaching model for children with disabilities, with a strong theoretical basis, and ability to be customized to children and families' resources, environmental settings, child age and developmental stage | Behavioural | Solution-Focused Coaching Group |
Primary outcome
Change in Canadian Occupational Performance Measure (COPM) scores
Time frame: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
The COPM is an evidence-based outcome measure designed to capture a participant's self-perception of performance in everyday living, over time. Participants will identify occupational performance problems in the areas of SELF-CARE (personal care, functional mobility, and community management), PRODUCTIVITY (paid or unpaid work, household management, and school and/or play), and LEISURE (quiet recreation, active recreation, and socialization). They will then rate each one in terms of its IMPORTANCE in their life on a scale of 1 (not important at all) to 10 (extremely important). Respondents will pick 5 problems and for each problem rate: PERFORMANCE (how would you rate the way that you do this activity now?) on a scale of 1 (not able to do it at all) to 10 (able to do it extremely well) SATISFACTION (How satisfied are you with the way you do this activity now?) on a scale of 1 (not satisfied at all) to 10 (extremely satisfied).
1 secondary outcome
Change Goal Attainment Scaling (GAS) scores
Time frame: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 30837255McPherson AC, Biddiss E, Chen L, Church PT, de Groot JF, Keenan S, King G, Lui T, Maltais DB, Merette C, Moffet H, Moola F, Schwellnus H. Children and Teens in Charge of their Health (CATCH): A protocol for a feasibility randomised controlled trial of solution-focused coaching to foster healthy lifestyles in childhood disability. BMJ Open. 2019 Mar 4;9(3):e025119. doi: 10.1136/bmjopen-2018-025119.
- Individual participant dataSharing planned: No
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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.
Amy McPherson, PhD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solution-Focused Coaching in Pediatric Rehabilitation in people with Spina Bifida and Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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) scores (time frame: At first coaching session (immediately post-study enrollment/randomization) and at Time 2 (immediately post-coaching), 3 (3 months post-coaching), 4 (6 months post-coaching)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523806, which also lists 1 linked publication.
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 11 Mar 2022.