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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
participation-based intervention
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, participation-based intervention, community participation, family empowerment, randomized controlled trial

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang Gung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
October 22, 2018
Last Updated
August 24, 2022
Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03721913
Brief Title
Participation-based Intervention on Community Participation and Parent Empowerment for Children With ASD
Acronym
PBI-ASD
Official Title
Efficacy of Participation-based Intervention on Community Participation and Parent Empowerment for Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University
Collaborators
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism, participation-based intervention, community participation, family empowerment, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be masked for assessments of family empowerment
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive the intervention during the study.
Intervention Type
Other
Intervention Name(s)
participation-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores
Description
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
Title
Change in the Goal Attainment Scaling (GAS) scores
Description
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 Outcome Measure Information:
Title
Parent Empowerment and Efficacy Measure (PEEM)
Description
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
Title
Family Quality of Life (FaQoL)
Description
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
Title
Chinese version of Family-Professional Partnership Scale (FPPS-P-C)
Description
(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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Ju Kang, PhD
Organizational Affiliation
Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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

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