Clinical trial NCT03721913: Participation-based Intervention on Community Participation and Parent Empowerment for Children With ASD
Official title: Efficacy of Participation-based Intervention on Community Participation and Parent Empowerment for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
participation-based intervention
community participation
family empowerment
randomized controlled trial
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2018-10-26
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores
timeFrame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks
measure: Change in the Goal Attainment Scaling (GAS) scores
timeFrame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks
Secondary outcomes:
measure: Parent Empowerment and Efficacy Measure (PEEM)
timeFrame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks
measure: Family Quality of Life (FaQoL)
timeFrame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks
measure: Chinese version of Family-Professional Partnership Scale (FPPS-P-C)
timeFrame: post-intervention at 12 weeks and follow-up at 24 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
affiliation: Chang Gung University
name: Lin-Ju Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References: