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Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096430
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Neurodevelopmental Disorders Cerebral Palsy Behavioral: ENGAGE approach (child-oriented goal-setting) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will use a pragmatic, cluster randomized controlled trial (RCT) design with therapists randomized to one of two groups; the ENGAGE intervention group or the usual care control group.
Masking: Single (Outcomes Assessor)
Masking Description: Trained assessors, blinded to group allocation, will complete the measures with families. Family members will be blinded to all initial responses on the measures.
Primary Purpose: Treatment
Official Title: Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ENGAGE approach (child-oriented goal-setting)
Therapists will receive training on our principles-based goal setting approach and strategies in the goal setting toolbox. Training will include an overview of tools and strategies including the Perceived Efficacy and Goal Setting Tool (PEGS) and the Pediatric Activity Card Sort (PACS). In addition, we will provide training on Goal Attainment Scaling and administration of the Canadian Occupational Performance Measure (COPM). We will introduce simple strategies to assist children in identifying goals and to ensure ongoing focus on goals using principles of motivational interviewing, strategies to assess and nurture perceived competence (self-efficacy), and child-friendly feedback strategies on goal-related performance.
Behavioral: ENGAGE approach (child-oriented goal-setting)
See description of experimental arm.

No Intervention: Usual care
The control group will comprise of usual care.



Primary Outcome Measures :
  1. Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days of completing therapy), and 3) at 3-months post-treatment ]
    Change in the COPM will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. The COPM is an interview style measure in which a child is asked by an assessor to identify goal areas and then rate their current level on a 1 to 10 scale as far as importance, satisfaction and performance. A higher score represents a more favorable outcome.


Secondary Outcome Measures :
  1. Child engagement in therapy will be measured using the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-SP). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in the (PRIME-SP) will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment.

  2. Perceived confidence will be measured using the Belief in Goal Self-Competence Scale [BiGSS]. [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in the BIGSS will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. BIGSS assess percieved using a 10-point Likert scale ("How confident do you feel that you can do this activity?). A higher score represents a more favorable outcome.

  3. Goal related performance will be measured using the Goal Attainment Scaling (GAS). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in GAS will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment.

  4. Participation for young children will be measured using the Participation and Environment Measure for Children & Youth (PEM-CY). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in the PEM-CY will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. This questionnaire is completed by a child (if 8 years or older) or parent. The participant responds to whether they have performed the activity in the last few weeks, who they did it with, where they did it and how much they enjoyed it.

  5. Quality of life for children will be measured using the KIDSCREEN-27. [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in the KIDSCREEN-27 will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. The KIDSCREEN-27 contains 27 items covering five dimensions: physical well-being (5 items), psychological well-being (7 items), parent relations and autonomy (7 items), social support and peers (4 items), and school (4 items). Each item rates frequency of behaviours/feelings or intensity of attitudes on a 5-point scale, with a higher score reflecting a more favorable outcome.

  6. Caregiver quality of life will be measured with the Caregiver Quality of Life (CarerQol-7D). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in CarerQol-7D will be examined between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. CarerQol is a 7-item questionnaire that evaluates the subjective burden experienced by caregivers across seven dimensions, including fulfillment, relational problems, mental health, daily activities, financial, physical health and support along with overall well-being on a VAS scale.

  7. Functional abilities will be measured with the Pediatric Evaluation of Disability Inventory (PEDI-CAT). [ Time Frame: 1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment ]
    Change in the PEDI-CAT will be examined between between baseline (pre-treatment) and post-treatment (within 10 days of completing therapy), and post-treatment (within 10 days of completing therapy) and 3-months post-treatment. The PEDI-CA T includes domains that align with the I CF-CY domains of activity (daily activities, mobility, social/cognitive) and participation. A parent of each participant will complete the content-balanced version of the PEDI-CA T using iPads at each site. An algorism based on item response theory selects items to minimizes the number ofresponses required, so parents answer up to -30 items/domain.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria are children with a diagnosed disability who:

  1. are between the ages of 5-12 years
  2. are able to engage in the goal-setting process (determined by therapists)
  3. are referred to PT and/or OT for a period of direct treatment
  4. speak English.

Children will be excluded from the trial if:

  1. the parent or guardian who attends therapy does not speak English
  2. the child has a diagnosis that suggests developmental regression
  3. the child has uncontrolled seizures (i.e., seizure within the past 2 months).

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): NCT04096430


Contacts
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Contact: Lesley Pritchard-Wiart, PhD 780-492-2971 lwiart@ualberta.ca
Contact: Sandy Thompson-Hodgetts, PhD 780-492-8416 sandy.hodgetts@ualberta.ca

Locations
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Canada, Alberta
Renfrew Educational Services
Calgary, Alberta, Canada, T2E 6S5
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-8416    sandy.hodgetts@ualberta.ca   
Society for Treatment of Autism
Calgary, Alberta, Canada, T2J 0E8
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-8416    sandy.hodgetts@ualberta.ca   
Children's Rehabilitation Services, Alberta Health Services
Camrose, Alberta, Canada
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-8416    sandy.hodgetts@ualberta.ca   
Centre for Autism Services Alberta
Edmonton, Alberta, Canada, T6E 5H5
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-2971    sandy.hodgetts@ualberta.ca   
Children's Rehabilitation Services, Alberta Health Services
Grande Prairie, Alberta, Canada
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-8416    sandy.hodgetts@ualberta.ca   
Children's Rehabilitation Services, Alberta Health Services
Red Deer, Alberta, Canada
Contact: Lesley Wiart, PhD    780-492-2971    lwiart@ualberta.ca   
Contact: Sandy Hodgetts, PhD    780-492-8416    sandy.hodgetts@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Alberta Health Services
Investigators
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Principal Investigator: Lesley Pritchard-Wiart, PhD University of Alberta, Faculty of Rehabilitation Medicine

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04096430    
Other Study ID Numbers: Pro00090963
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 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
Disease
Autism Spectrum Disorder
Neurodevelopmental Disorders
Pathologic Processes
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Child Development Disorders, Pervasive
Mental Disorders