Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong
Primary Purpose
Intellectual Disability, Mild
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-determination Enhancement Group
Self-determination Enhancement Plus Group
Leisure activity group
Sponsored by
About this trial
This is an interventional other trial for Intellectual Disability, Mild focused on measuring Self-determination enhancement;, intellectual disability;, culturally-tailored group;, Chinese societies;, randomised controlled trial
Eligibility Criteria
Inclusion Criteria:
- Chinese people who have mild intellectual disability (i.e., assessed in their most recent psychological report)
- Aged 18 or above
- Able to master basic comprehension and verbal communication skills
- Willing to complete the group intervention.
Exclusion Criteria:
- Those who demonstrate severe challenging behaviours will be excluded
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intervention Group
Intervention PLUS Group
Comparison Group
Arm Description
Outcomes
Primary Outcome Measures
Changes of self-determination competence level
The AIR Self-Determination Scale: the Chinese Version (AIR SDS-C) (Wong, Wong, Zhuang & Liu, 2017) will be used. This is a 24-items, 5-point Likert-scale questionnaire to measure the self-determination of people with intellectual disability
Secondary Outcome Measures
Changes of personal well-being questionnaire
The Personal Well-being: Intellectual Disability (Cantonese) 3rd Edition (PWI-C). This is an 8-item, 5-point Likert-scale questionnaire used to measure the subjective well-being of people with intellectual disability
Full Information
NCT ID
NCT05167929
First Posted
November 22, 2021
Last Updated
March 7, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05167929
Brief Title
Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong
Official Title
Effects of a Culturally-tailored Personal Self-Determination Enhancement Intervention for People With Mild Intellectual Disabilities and Their Caregivers in Hong Kong - A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Background Self-determination is regarded as an adult outcome for people with intellectual disability (ID). Students with ID in western countries learn self-determination knowledge and skills through the systematic curriculum in schools. However, the curriculum for adults with ID is still underdeveloped in the West. In Hong Kong, the self-determination curriculum is rarely available in any setting.
Objective The proposed study aims to develop a culturally-tailored self-determination enhancement group intervention for adults with ID and to evaluate its effectiveness.
Method The proposed study will consist of two phases. Phase one will develop the protocol for the self-determination enhancement intervention and establish its implementation fidelity through a panel review and pilot study. This phase will last eight months. Phase two will adopt a randomised controlled trial with pre-test, post-test and three-month follow-up. A total of 120 participants will be randomly assigned to three conditions: Self-determination enhancement group, Self-determination enhancement PLUS group (+ parents' involvement) and leisure activity group as a control condition. Five groups will be organised for each of the three conditions over 18 months. There will be 10 sessions per group covering the self-determination core components such as self-understanding, goal-setting and attaining, self-regulating and plan adjusting. Components for parents include understanding self-determination and skills in supporting people with ID to exercise self-determination through positive interaction. Validated instruments in Chinese will be filled in by participants. Statistical analyses will be conducted to examine if the effectiveness of this group intervention can be found and sustained over a three-month period, and the magnitude of change in self-determination competencies and quality of life.
Implications The proposed study is the first evidence-based local study aimed at examining a culturally-tailored self-determination enhancement intervention for people with ID. If the intervention demonstrated as effective, it will be used or modified for use with Chinese-speaking people with ID in different parts of the world.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability, Mild
Keywords
Self-determination enhancement;, intellectual disability;, culturally-tailored group;, Chinese societies;, randomised controlled trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Intervention PLUS Group
Arm Type
Experimental
Arm Title
Comparison Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Self-determination Enhancement Group
Intervention Description
The self-determination enhancement group - Each group has eight participants. There will be 10 sessions per group and each session will last 1.5 hours.
Intervention Type
Behavioral
Intervention Name(s)
Self-determination Enhancement Plus Group
Intervention Description
The self-determination enhancement PLUS group - Each group has eight participants and their caregivers. There will be 10 sessions per group and each session will last 1.5 hours. Meanwhile, their caregivers will attend four sessions separately and each session will last 1.5 hours.
Intervention Type
Behavioral
Intervention Name(s)
Leisure activity group
Intervention Description
Leisure activity group - Leisure activity group is the comparison group. Each group will consist of eight adults with mild intellectual disability. There will be 10 sessions for the group and each session will last for 1.5 hours.
Primary Outcome Measure Information:
Title
Changes of self-determination competence level
Description
The AIR Self-Determination Scale: the Chinese Version (AIR SDS-C) (Wong, Wong, Zhuang & Liu, 2017) will be used. This is a 24-items, 5-point Likert-scale questionnaire to measure the self-determination of people with intellectual disability
Time Frame
Pretest (T0) - baseline; posttest (T1) - after the completion of the intervention (3 months later from the pretest); and follow-up test (T2) (3 months later from the posttest)
Secondary Outcome Measure Information:
Title
Changes of personal well-being questionnaire
Description
The Personal Well-being: Intellectual Disability (Cantonese) 3rd Edition (PWI-C). This is an 8-item, 5-point Likert-scale questionnaire used to measure the subjective well-being of people with intellectual disability
Time Frame
Pretest (T0) - baseline; posttest (T1) - after the completion of the intervention (3 months later from the pretest); and follow-up test (T2) (3 months later from the posttest)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese people who have mild intellectual disability (i.e., assessed in their most recent psychological report)
Aged 18 or above
Able to master basic comprehension and verbal communication skills
Willing to complete the group intervention.
Exclusion Criteria:
Those who demonstrate severe challenging behaviours will be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phyllis KS WONG, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35162786
Citation
Wong PKS. Study Protocol for a Randomized Controlled Trial Evaluating the Effectiveness of a Group-Based Self-Determination Enhancement Intervention for Adults with Mild Intellectual Disability and Their Caregivers. Int J Environ Res Public Health. 2022 Feb 4;19(3):1763. doi: 10.3390/ijerph19031763.
Results Reference
derived
Learn more about this trial
Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong
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