NCT05167929

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

November 22, 2021

Last Update Submit

March 7, 2022

Conditions

Keywords

Self-determination enhancement;intellectual disability;culturally-tailored group;Chinese societies;randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes of personal well-being questionnaire

    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)

Study Arms (3)

Intervention Group

EXPERIMENTAL
Behavioral: Self-determination Enhancement Group

Intervention PLUS Group

EXPERIMENTAL
Behavioral: Self-determination Enhancement Plus Group

Comparison Group

ACTIVE COMPARATOR
Behavioral: Leisure activity group

Interventions

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 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.

Intervention PLUS 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.

Comparison Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those who demonstrate severe challenging behaviours will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intellectual DisabilityLymphoma, Follicular

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Phyllis KS WONG, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 22, 2021

Study Start

August 1, 2021

Primary Completion

March 1, 2022

Study Completion

April 1, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations