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

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ClinicalTrials.gov Identifier: NCT03721913
Recruitment Status : Enrolling by invitation
First Posted : October 26, 2018
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Lin-Ju Kang, Chang Gung University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: participation-based intervention Not Applicable

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.


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Study Type : Interventional
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will be masked for assessments of family empowerment
Primary Purpose: Treatment
Official Title: Efficacy of Participation-based Intervention on Community Participation and Parent Empowerment for Children With Autism Spectrum Disorder
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : April 23, 2019
Estimated Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

No Intervention: Control group
The control group will not receive the intervention during the study.



Primary Outcome Measures :
  1. Change in the Canadian Occupational Performance Measure (COPM) performance and satisfaction scores [ Time Frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks ]
    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.

  2. Change in the Goal Attainment Scaling (GAS) scores [ Time Frame: From baseline to post-intervention at 12 weeks and follow-up at 24 weeks ]
    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 :
  1. Parent Empowerment and Efficacy Measure (PEEM) [ Time Frame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks ]
    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.

  2. Family Quality of Life (FaQoL) [ Time Frame: Baseline, post-intervention at 12 weeks and follow-up at 24 weeks ]
    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.

  3. Chinese version of Family-Professional Partnership Scale (FPPS-P-C) [ Time Frame: post-intervention at 12 weeks and follow-up at 24 weeks ]
    (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).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721913


Locations
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Taiwan
Chang Gung University
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung University
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Lin-Ju Kang, PhD Chang Gung University

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Responsible Party: Lin-Ju Kang, Assistant Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT03721913     History of Changes
Other Study ID Numbers: 201800429A3
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lin-Ju Kang, Chang Gung University:
Autism
participation-based intervention
community participation
family empowerment
randomized controlled trial

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders