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Children and Teens in Charge of Their Health (CATCH)

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ClinicalTrials.gov Identifier: NCT03523806
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Laval University
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief 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).

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.


Condition or disease Intervention/treatment Phase
Spina Bifida Cerebral Palsy Health Behavior Behavioral: Solution-Focused Coaching in Pediatric Rehabilitation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : March 23, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Solution-Focused Coaching Group
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.
Behavioral: Solution-Focused Coaching in Pediatric Rehabilitation
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

No Intervention: Control Group
Half of the participants (n=15) will not be receiving coaching



Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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) ]

    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.


Other Outcome Measures:
  1. Change in Habitual Activity Estimation Scale scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]

    A child questionnaire estimating percent of time spent inactive, somewhat inactive, somewhat active, and very active on a typical school day and Saturday. Each question represents 1 time point in the day. Estimated percent ranging from 0-100% for all 4 activity levels must add up to 100% per question.

    Activity Level Description

    • Inactive - lying down, resting
    • Somewhat inactive - activities that are mostly done sitting down.
    • Somewhat active - walking, shopping, light chores, playing with pet
    • Very active - require lots of movement and make you breathe/sweat hard

    The questionnaire also asks participants to rate their:

    • Overall level of activity (very inactive to very active) on a typical school day/Saturday
    • How typical the school day/Saturday described was in the last 6 months (very much like most days to very different from most days)
    • Changes in a participant's activity level from 6 months on a school day/weekend (choice of much less active to much more active)

  2. Change in Dietary Screener Questionnaire scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]

    A child questionnaire assessing dietary intake over the past 30 days and is validated against 24 hour multiple recall.

    The questionnaire asks participants they had specific types of foods and beverages in the last month as well as the type of milk and cereals consumed.

    For beverages, the scale ranges are:

    • Never
    • 1 time last month
    • 2 - 3 times last month
    • 1 time per week
    • 2 times per week
    • 3 - 4 times per week
    • 5 - 6 times per week
    • 1 time per day
    • 2 - 3 times per day
    • 6 or more times per day

    For food, the scale ranges are:

    • Never
    • 1 time last month
    • 2 - 3 times last month
    • 1 time per week
    • 2 times per week
    • 3 - 4 times per week
    • 5 - 6 times per week
    • 1 time per day
    • 2 or more times per day

  3. Change in Arc's Self-Determination Scale scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]

    A child questionnaire assessing self-determination. Only multiple choice domains 1 (autonomy), 3 (psychological empowerment), and 4 (self-realization) will used.

    Domain 1 scores range from 0 ("I don't even have a chance) to 3 (I do every time I have a chance) for each question (21 questions) and summed (max. score of 96). Higher scores indicate higher levels or autonomy.

    Domain 2 scores are 0 or 1 (16 points total) depending on response. Answers reflecting psychological empowerment (e.g. beliefs in ability, perceptions of control, and expectations of success) are scored 1 and those that do not reflect a psychologically empowered belief or attitude are scored 0. Higher scores indicate more psychological empowerment.

    Domain 3 scores are 0 (answer not reflecting positive self-awareness/knowledge) or 1 (answer reflecting positive self-awareness/knowledge) based on response (total 15 points). Higher scores represent greater self-realization.


  4. Change in Physical Activity Self-efficacy Scale scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]
    A child questionnaire assessing confidence in the ability to be physically active when faced with challenges. Participants will rate each physical activity self-efficacy statement with either a "yes" or "no" (e.g. I think I can ask my parents or another adult to sign me up for a physical activity - yes or no?). Higher number of "yes" responses indicate higher physical activity self-efficacy.

  5. Change in Self-Efficacy for Healthy Eating scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]

    A child questionnaire assessing participants' feelings of competence for making healthy food choices in: social, emotional, and typical situations.

    Participants rate each self-efficacy statement for healthy eating (e.g. If you wanted to, how sure are you that you could eat healthy foods when you are… at the mall.. with your friends..etc.) on a scale ranging from:

    • Not sure at all
    • Not sure
    • Neither sure nor unsure
    • Fairly sure
    • Very sure Higher scores indicate higher self-efficacy for healthy eating.

  6. Change in BMI [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]
    Weight will be measured in kg and height will be measured in cm to determine BMI calculated based on height and weight in kg/m^2

  7. Change in the Family Eating and Activity Habits Questionnaire scores [ Time Frame: Time 1 Baseline (upon study enrollment), Time 2 (6 months post-baseline or immediately post-coaching), 3 (9 months post-baseline or 3 months post coaching), 4 (12 months post-baseline or 6 months post-coaching) ]

    This is a 32-item parent-report assessment to assess the health behaviours of family members as well as the nature of the home environment. Respondent rates each eating and activity habit for the participant and both parents as applicable. There are 4 sub-scales: Physical activity, eating habits and style, hunger and satiety cues, and obesogenic environment-exposure.

    Individual scores range from 0 - 4. Sub-scale scores are calculated by summing individual scores in the sub-scale for each family member. A total score was generated by summing all individual scores for each family member. The total score is considered an index of overall inappropriateness of eating patterns, and the higher the score, the more obesogenic the environment.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523806


Contacts
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Contact: Amy McPherson, PhD 416-425-6220 ext 6378 amcpherson@hollandbloorview.ca
Contact: Toni Lui, MSW 416-425-6220 ext 6521 tlui@hollandbloorview.ca

Locations
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Canada, Ontario
Thames Valley Children's Centre Not yet recruiting
London, Ontario, Canada, N6C 5Y6
Contact: Toni Lui, MSW    416-425-6220 ext 6521    tlui@hollandbloorview.ca   
Principal Investigator: Amy McPherson, PhD         
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G1R8
Contact: Amy McPherson, PhD    416-425-6220 ext 6378    amcpherson@hollandbloorview.ca   
Principal Investigator: Amy McPherson, PhD         
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Laval University
Investigators
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Principal Investigator: Amy McPherson, PhD Holland Bloorview Kids Rehabilitation Hospital
  Study Documents (Full-Text)

Documents provided by Holland Bloorview Kids Rehabilitation Hospital:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03523806     History of Changes
Other Study ID Numbers: CATCH-17-752
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cerebral Palsy
Spinal Dysraphism
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Pharmaceutical Solutions