Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intellectual Disability, Mild
• Intervention / Treatment: Behavioral: Self-determination Enhancement Group; Behavioral: Self-determination Enhancement Plus Group; Behavioral: Leisure activity group

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group	Behavioral: Self-determination Enhancement Group; 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.
Experimental: Intervention PLUS Group	Behavioral: Self-determination Enhancement Plus Group; 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.
Active Comparator: Comparison Group	Behavioral: Leisure activity group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Measures

Outcome Measure	Measure Description	Time Frame
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	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)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Phyllis KS WONG, PhD, Chinese University of Hong Kong

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomised controlled trial; Self-determination enhancement;; intellectual disability;; culturally-tailored group;; Chinese societies
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 24617019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No