Children and Teens in Charge of Their Health

NCT03523806 | Unknown

• 1 other identifier: CATCH-17-752
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Spina Bifida; Cerebral Palsy; Health Behavior

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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)

Other Outcomes (7)

• Change in Habitual Activity Estimation Scale scores

  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)

• Change in Dietary Screener Questionnaire scores

  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)

• Change in Arc's Self-Determination Scale scores

  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)

Study Arms (2)

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.

Behavioral: Solution-Focused Coaching in Pediatric Rehabilitation

Control Group

NO INTERVENTION

Half of the participants (n=15) will not be receiving coaching

Interventions

Solution-Focused Coaching in Pediatric Rehabilitation BEHAVIORAL

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

Solution-Focused Coaching Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Primary caregiver to a study participant
• Can communicate in English and respond to questions requiring some reflection and insight

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Laval University: collaborator

Study Sites (2)

Thames Valley Children's Centre

London, Ontario, N6C 5Y6, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 30837255 DERIVED

MeSH Terms

Conditions

Spinal Dysraphism; Cerebral Palsy; Health Behavior

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Behavior

Study Officials

• Amy McPherson, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 14, 2018
• Study Start: March 23, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)