Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are between the ages of 5-12 years
are able to engage in the goal-setting process (determined by therapists)
are referred to PT and/or OT for a period of direct treatment
speak English.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
ENGAGE approach (child-oriented goal-setting)
BehavioralSee description of experimental arm.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: ENGAGE approach (child-oriented goal-setting)Experimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Goal performance and satisfaction will be measured using the Canadian Occupational Performance Measure (COPM).
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.
Time frame
1) baseline (pre-treatment), 2) post-treatment (within 10 days of completing therapy), and 3) at 3-months post-treatmentSecondary outcomes
1
Child engagement in therapy will be measured using the Pediatric Rehabilitation Intervention Measure of Engagement (PRIME-SP).
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.
Time frame
1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment2
Perceived confidence will be measured using the Belief in Goal Self-Competence Scale [BiGSS].
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.
Time frame
1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment3
Goal related performance will be measured using the Goal Attainment Scaling (GAS).
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.
Time frame
1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatment4
Participation for young children will be measured using the Participation and Environment Measure for Children & Youth (PEM-CY).
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.
Time frame
1) baseline (pre-treatment), 2) post-treatment (within 10 days), and 3) at 3-months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Alberta Health services
Collaborator
Source ClinicalTrials.gov