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CompletedNCT03721913PBI-ASDUpdated Aug 26, 2022

Participation-based Intervention on Community Participation and Parent Empowerment for Children With ASD

An interventional study of participation-based intervention in Autism Spectrum Disorder, sponsored by Chang Gung University. Completed at 1 site in Taiwan. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by Chang Gung University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
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Study summary

Community participation of children with ASD is affected by child (including body function and personal factors), family and environmental factors. This study proposes an innovative Participation-based intervention based on the principles of self-determined, family-centered, strength-based, and solution-focused approaches. This intervention targets on promoting children's community participation, and forms solution strategies from analyzing the strength and needs of child, family, and environment. The aim of this study is to investigate the efficacy of participation-based intervention on community participation and family empowerment for children with ASD 6-10 years of age.

Read the detailed description

Children with Autism Spectrum Disorder (ASD) have social interaction and communication disorders, restricted interests and repetitive behaviors, which may further restrict daily activities and participation. Participation of children with ASD often are more restricted in the community than at home and school, due to problems such as environmental barriers and resources inadequacy. Research showed that school-age children with ASD participated less in social, leisure and sports activities than children with typical development, thus may result in loneness or social isolation and impact on long-term physical and psychological health.

Community participation of children with ASD is affected by child (including body function and personal factors), family and environmental factors. This study proposes an innovative Participation-based intervention based on the principles of self-determined, family-centered, strength-based, and solution-focused approaches. This intervention targets on promoting children's community participation, and forms solution strategies from analyzing the strength and needs of child, family, and environment. The aim of this study is to investigate the efficacy of participation-based intervention on community participation and family empowerment for children with ASD 6-10 years of age.

This study is proposed as a 2-year project that will use a stratified randomized controlled trial design to examine the efficacy of participation-based intervention (experimental group) in comparison to no additional intervention (control group). The study period includes 12-week intervention phase and 12-week follow-up phase, and 3 outcome measures: pre-test, post-test, and follow-up. The primary outcomes are children's community participation, the secondary outcomes are parental empowerment, family quality of life, and satisfaction with partnerships. This study will have great impact on promoting collaboration among child, family and therapists, and supporting full inclusion in society of children with ASD and their families.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Autism
  • participation-based intervention
  • community participation
  • family empowerment
  • randomized controlled trial
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In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 24 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Chang Gung University is the lead sponsor of 63 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children are elementary school students between the ages of 6 and 10
  • Diagnosed with Autism spectrum disorder by DSM-V with a medical certificate, and reached the cut-off score (7 points) of Autism Behavior Checklist-Taiwan version(ABC-T).
  • Children have an IQ of at least 70 (as measured by Wechsler Intelligence Scale for Children).
  • Parents agree to participate in this study and sign the consent form.
  • Children over 7 years should provide written consent form.

Exclusion criteria

Exclusion Criteria:

  • Children with unstable physical conditions within 3 months, such as cancer, having surgery, infection, or other active medical conditions.
  • Children have known genetic conditions (e.g., Down syndrome, Fragile X Syndrome).
  • Children have diagnosis associated with physical disability (e.g. cerebral palsy, congenital malformations, or musculoskeletal disorders)
  • Children have significant sensory impairments such as visual or hearing impairments.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Intervention group

    The participation-based intervention is a goal-orientated, family-centered, and self-determined approach that emphasize on solution strategies based on child and family-selected goals. Intervention strategies will be formed by analyzing the strength and needs of child, family, and environment, and implemented by collaboration between family and interventionists.

    Other: participation-based intervention

  • No intervention
    Control group

    The control group will not receive the intervention during the study.

Interventions

  • Otherparticipation-based intervention

    The participation-based intervention is a goal-orientated, family-centered, and self-determined approach that emphasize on solution strategies based on child and family-selected goals. Intervention strategies will be formed by analyzing the strength and needs of child, family, and environment, and implemented by collaboration between family and interventionists.

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What researchers measure

Primary outcomes

  1. Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores

    The COPM is a measure for identifying children's participation problems and prioritizing the goals. The parents will be asked to use a 10-point rating scales (1-10: higher scores indicating better performance and higher satisfaction) to rate their perception of performance and satisfaction of the goals.

    Time frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks

  2. Change in the Goal Attainment Scaling (GAS) scores

    The GAS is a measure for evaluating the goal attainment. It is a five level scale ranged from -2 to +2 where -2 represented the level of performance before intervention, 0 the expected level of attainment after intervention and +2 represented a level of attainment that exceeded expectations.

    Time frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks

Secondary outcomes

  1. Parent Empowerment and Efficacy Measure (PEEM)

    The PEEM is a 20-item questionnaire designed to measure parent functioning. The parents will be asked to use a 10-point scale to indicate how well each statement captures the way they feel about themselves in relation to their role as parent. A rating of 1 is used to indicate that the statement is a poor match for the way they feel and sounds nothing like them. A rating of 10 indicates that the statement is a perfect match and describes exactly how they feel. The total possible score ranges from 20 to 200.

    Time frame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks

  2. Family Quality of Life (FaQoL)

    The FaQoL(McWilliam, 2011) is a 40-item questionnaire rate on a 5-point scale (1-poor to 5-excellent) for parents to rate their perception of satisfaction.

    Time frame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks

  3. Chinese version of Family-Professional Partnership Scale (FPPS-P-C)

    (only for the intervention groups) The FPPS-P-C is a 18-item scale for assessing parents' perceptions of the importance of and their satisfaction with family-professional partnerships. The parents will be asked to indicate how important each item was for their partnership with a professional serving their child using a 5-point scale, ranging from 1 (not at all important) to 5 (very important).

    Time frame: post-intervention at 12 weeks and follow-up at 24 weeks

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Study locations

1 site
  • Chang Gung University
    Taoyuan, 333, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03721913
Lead sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital
Responsible party
Lin-Ju Kang (Assistant Professor, Chang Gung University) — Principal investigator
First posted
Oct 26, 2018
Start date
Oct 23, 2018
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020
Last update
Aug 26, 2022

Study contacts

Lin-Ju Kang, PhD
principal investigator · Chang Gung University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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