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

NCT03721913 | Completed

• 1 other identifier: 201800429A3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; participation-based intervention; community participation; family empowerment; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (3)

• Parent Empowerment and Efficacy Measure (PEEM)

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

• Family Quality of Life (FaQoL)

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

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

  post-intervention at 12 weeks and follow-up at 24 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

participation-based intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung University: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lin-Ju Kang, PhD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be masked for assessments of family empowerment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: October 23, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

TW (1)