Intellectual Disability, MildNCT05167929
Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong
A study testing Self-determination Enhancement Group, Self-determination Enhancement Plus Group and Leisure activity group in people with Intellectual Disability, Mild, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intellectual Disability, Mild
- What is being tested?
- Self-determination Enhancement Group, Self-determination Enhancement Plus Group and Leisure activity group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those who demonstrate severe challenging behaviours will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Intellectual Disability, Mild
- Being tested
- Self-determination Enhancement Group, Self-determination Enhancement Plus Group, Leisure activity group
- Keywords
- Self-determination enhancement;, intellectual disability;, culturally-tailored group;, Chinese societies;, randomised controlled trial
- Medical subject headings
- Intellectual Disability, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-determination Enhancement GroupBehavioural
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.
Self-determination Enhancement Plus GroupBehavioural
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.
Leisure activity groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Self-determination Enhancement Group |
| Intervention PLUS Group | Experimental | Not described Receives: Behavioral: Self-determination Enhancement Plus Group |
| Comparison Group | Active comparator | Not described Receives: Behavioral: Leisure activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start1 Aug 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disability, MildStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong King Shui, Chinese University of Hong Kong
- Investigators
- Phyllis KS WONG, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167929
- Sponsor's protocol ID
- 24617019
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35162786
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05167929
- Acronym / sponsor ID
- 24617019
- Conditions
- Intellectual Disability, Mild
- Keywords
- Self-determination enhancement;, intellectual disability;, culturally-tailored group;, Chinese societies;, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who demonstrate severe challenging behaviours will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-determination Enhancement GroupThe self-determination enhancement group - Each group has eight participants. There will be 10 sessions per group and each session will last 1.5 hours. | Behavioural | Intervention Group |
| Self-determination Enhancement Plus GroupThe 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. | Behavioural | Intervention PLUS Group |
| Leisure activity groupLeisure 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. | Behavioural | Comparison Group |
Primary outcome
Changes of self-determination competence level
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)
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
1 secondary outcome
Changes of personal well-being questionnaire
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Derived from this study: PubMed 35162786Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phyllis KS WONG, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-determination Enhancement Group, Self-determination Enhancement Plus Group and Leisure activity group in people with Intellectual Disability, Mild, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of self-determination competence level (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.