Child-Oriented Goal-Setting for Pediatric Rehabilitation

Recruiting at 5 trial locations

Overseen By Sandy Thompson-Hodgetts, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Developmental regression, Uncontrolled seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-8 weeks

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a child-focused goal-setting approach called ENGAGE (child-oriented goal-setting) can improve therapy outcomes for children with disabilities. The study will compare results from those using ENGAGE with those receiving usual care, focusing on goal achievement, daily life impact, and family satisfaction. It will also assess whether ENGAGE is more cost-effective than traditional methods. Children diagnosed with a disability, who speak English, and are referred for physical or occupational therapy are eligible to participate. As an unphased trial, this study provides a unique opportunity for families to contribute to innovative research that could enhance therapy for children with disabilities.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your child has uncontrolled seizures, they cannot participate in the trial.

What prior data suggests that the ENGAGE approach is safe for children in pediatric rehabilitation?

Research has shown that the ENGAGE approach, which focuses on setting goals for children in rehabilitation, is generally well-received. Related studies indicate that children, parents, and therapists find this approach boosts motivation and involvement in therapy. Major reports of negative effects linked to the ENGAGE method have not emerged, suggesting it is safe for children with developmental disabilities. However, it is important to note that this method involves setting goals and strategies rather than serving as a medical treatment, which typically means it is less likely to cause physical side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENGAGE approach for pediatric rehabilitation because it centers on child-oriented goal-setting, making it distinct from traditional methods. Unlike standard treatments that might focus more on therapist-directed goals, ENGAGE empowers children by involving them directly in the goal-setting process using tools like the Perceived Efficacy and Goal Setting Tool (PEGS) and the Pediatric Activity Card Sort (PACS). This approach also incorporates motivational interviewing and strategies to boost self-efficacy, which can foster a child's perceived competence and engagement. The personalized and motivational nature of ENGAGE could potentially improve the effectiveness of rehabilitation by aligning goals with the child's own aspirations and capabilities.

What evidence suggests that the ENGAGE approach is effective for pediatric rehabilitation?

Research has shown that the ENGAGE approach, tested in this trial, involves children in setting their own therapy goals and can greatly improve results in pediatric rehabilitation. Participants in this trial may receive the ENGAGE approach. Studies have found that when children help set their own goals, they become more motivated and involved in their therapy. This method identifies goals that excite children, leading to better participation and satisfaction with their progress. Early findings suggest that this approach can improve children's abilities and quality of life, making it a promising strategy in rehabilitation settings. ^{1 2 3 4 5}

Who Is on the Research Team?

Lesley Pritchard-Wiart, PhD

Principal Investigator

University of Alberta, Faculty of Rehabilitation Medicine

Are You a Good Fit for This Trial?

This trial is for children aged 5-12 with neurodevelopmental disabilities like autism or cerebral palsy, who are referred to physical or occupational therapy and can participate in goal-setting. They must speak English, as should their guardian. Children with developmental regression or uncontrolled seizures are excluded.

Inclusion Criteria

My child can participate in setting therapy goals.

My child is between 5-12 years old and has a diagnosed disability.

My child has been referred for physical or occupational therapy.

Exclusion Criteria

My child has been diagnosed with developmental regression.

My child has had a seizure in the last 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. Treatment block lengths vary from 3-8 sessions over 2-8 weeks.

2-8 weeks

Post-treatment Assessment

Identical assessments are conducted within 10 days of completing therapy to evaluate goal performance, satisfaction, and other outcomes.

Within 10 days

Follow-up

Participants are monitored for changes in goal performance, satisfaction, and quality of life at 3 months post-treatment.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ENGAGE approach (child-oriented goal-setting)

Trial Overview

The ENGAGE approach focuses on child-oriented goal-setting in pediatric rehabilitation. The study compares the effectiveness of ENGAGE against usual therapy practices by assessing improvements in children's abilities, participation levels, and quality of life for both the child and family.

How Is the Trial Designed?

Group I: ENGAGE approach (child-oriented goal-setting) Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

The control group will comprise of usual care.

ENGAGE approach (child-oriented goal-setting) is already approved in Canada for the following indications:

Approved in Canada as ENGAGE approach for:

• Paediatric rehabilitation for neurodevelopmental disabilities

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Published Research Related to This Trial

In a study of 122 children with severe acquired brain injury, families prioritized goals related to mobility, self-care, and communication during rehabilitation, highlighting the importance of child- and family-centered goal setting.

Therapists accurately predicted the expected levels of achievement for only 46% of the goals set, indicating a significant challenge in setting realistic outcomes, which families should be aware of during discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using child- and family-centred goal setting as an outcome measure in residential rehabilitation for children and youth with acquired brain injuries: The challenge of predicting expected levels of achievement. Kelly, G., Dunford, C., Forsyth, R., et al.[2020]

The ENGAGE approach to goal-setting in pediatric rehabilitation aims to enhance child motivation and engagement, potentially leading to better therapy outcomes compared to usual care, with a total of 96 children aged 5-12 participating in the trial.

This study will not only assess the effectiveness of the ENGAGE method but also explore its cost-effectiveness and identify barriers to implementation, providing valuable insights for improving child-focused rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-center, pragmatic, effectiveness-implementation (hybrid I) cluster randomized controlled trial to evaluate a child-oriented goal-setting approach in paediatric rehabilitation (the ENGAGE approach): a study protocol. Pritchard-Wiart, L., Thompson-Hodgetts, S., McKillop, AB., et al.[2023]

Collaborative goal setting between clinicians and families is crucial in pediatric rehabilitation, as it leads to more individualized interventions and actively engages families in the therapy process.

Evidence from four studies indicates that effective collaborative goal setting is linked to positive rehabilitation outcomes, justifying the investment of time and resources to implement it in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the challenges of collaborative goal setting with children and their families. Brewer, K., Pollock, N., Wright, FV.[2022]

The scoping review analyzed 62 articles and found that while family-centered care is emphasized in pediatric rehabilitation, established theoretical frameworks for goal setting are rarely utilized, indicating a gap in the literature.

Only a few studies evaluated the outcomes of goal setting, with the primary focus being on creating meaningful goals for families, suggesting a need for more research on the effectiveness of goal setting processes and their impact on rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal setting in paediatric rehabilitation for children with motor disabilities: a scoping review. Pritchard-Wiart, L., Phelan, SK.[2019]

Health care providers (HCPs) recognize the importance of solution-focused coaching (SFC) for goal-setting in pediatric rehabilitation, but they face significant challenges in implementing it effectively.

Key difficulties include a lack of individual skills and experience with SFC, insufficient preparation for clients to engage in goal-sharing, and inadequate organizational support within their teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the capability, opportunity, and motivation model of behaviour to assess provider perception of implementing solution-focused goal-setting in paediatric rehabilitation. Crawford, L., Colquhoun, H., Kingsnorth, S., et al.[2023]

Involving children in setting their own rehabilitation goals leads to increased motivation and a sense of being valued, as reported by both the children and their parents in a study with 9 children aged 5 to 12 years.

Parents and clinicians recognized the importance of collaboration in goal setting, suggesting that a relational autonomy approach, which emphasizes teamwork and shared decision-making, may enhance the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child, parent, and clinician experiences with a child-driven goal setting approach in paediatric rehabilitation. Pritchard, L., Phelan, S., McKillop, A., et al.[2022]

A review of various goal-setting theories highlights their importance in pediatric rehabilitation, emphasizing the need for a structured approach that considers the evolving roles of parents, siblings, and caregivers as well as the child's developmental capacity.

Key implications for practice include the necessity of setting specific and meaningful goals for children, enhancing self-efficacy, and adapting goal-setting processes to accommodate changing family dynamics over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of goal setting theories relevant to goal setting in paediatric rehabilitation. Pritchard-Wiart, L., Thompson-Hodgetts, S., McKillop, AB.[2022]

Parents' active involvement in setting and implementing rehabilitation goals for their preschoolers with cerebral palsy enhances their sense of competence and partnership with professionals, leading to better outcomes.

Concrete, family-centered goals that reflect parents' preferences and concerns are effective in promoting functional task practice in everyday home environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-setting in paediatric rehabilitation: perceptions of parents and professional. Øien, I., Fallang, B., Østensjø, S.[2010]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35764983/

A multi-center, pragmatic, effectiveness-implementation ...

This study will evaluate the effects of collaborative goal-setting in pediatric rehabilitation and inform effective implementation of child-focused goal- ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05017363

Evaluation of the Effectiveness of Child-oriented Goal ...

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 ...

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bmcpediatr.biomedcentral.com

bmcpediatr.biomedcentral.com/articles/10.1186/s12887-022-03381-4

A multi-center, pragmatic, effectiveness-implementation ...

Child-oriented goal-setting in pediatric rehabilitation may improve child motivation, engagement in therapy, child outcomes related to ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04096430

Evaluation of Effectiveness of Child-oriented Goal-setting ...

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32650674/

Child, parent, and clinician experiences with a child-driven ...

Conclusions: Engagement in goal setting resulted in the identification of functional goals that were perceived as motivating for children.