Intellectual DisabilityNCT05587647
The Effect of Transition to Adulthood Education Program on Family Quality of Life and Perceived Stress Level
A study testing Transition to Adulthood Education Program in people with Intellectual Disability, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. It has been found that parents who care for their children with intellectual disability (ID) for a long time have difficulties in coping with stress and their quality of life is adversely affected. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Transition to Adulthood Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Sep 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Whose child is registered with the disability center,
- Have a young adult child between the ages of 20 and 35 with moderate and severe mental disabilities,
- Speaking Turkish and literate Turkish,
- Not visually and speech impaired,
- Mothers who volunteered to participate in the study will be included.
Who cannot join
- Mothers who did not volunteer to participate in the study and were illiterate in Turkish were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Transition to Adulthood Education Program Given to Mothers of Children With Intellectual Disability on Family Quality of Life and Perceived Stress Level
Negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. It has been found that parents who care for their children with intellectual disability (ID) for a long time have difficulties in coping with stress and their quality of life is adversely affected. However, families play a key role in maintaining the care of their children with ID, so it is very important that parents are supported in the matters they need.
Read the detailed description
Mothers are generally the people who take on a large part of the burden of care for their children with intellectual disability (ID) in the family and are most affected by the negativities brought by the conditions. Providing support to mothers for the care and future planning of their children who have just passed into adult life and for their future planning is important both in terms of maintaining family well-being and creating positive effects in the lives of individuals with mental disabilities.
With this study, it is aimed to increase the quality of life of mothers and to reduce perceived stress levels with the training (YEGEP) modules to be given for the changing care needs of individuals with ID who have reached adulthood or are in transition. In addition, it is expected that the health risks of young adults with ID will be determined at an early stage, and their health will be improved and protected.
- Conditions
- Intellectual Disability
- Being tested
- Transition to Adulthood Education Program
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition to Adulthood Education ProgramOther
Also called There is no other intervention
YEGEP was developed by the authors based on the information in the literature, based on the needs of mothers of children who have reached adulthood or are going through. Three training modules are planned in line with current requirements. Education will also be supported by audio-visual and written materials. It is planned that the trainings, which will last for 3 weeks in total, for 1 hour a week for each group, in the form of 3 sessions of 1 hour with these contents, will be held at a disabled center. Titles of training modules:
- Developmental Period Characteristics of Young Adults with Intellectual Disabilities (Transition to Adulthood, Future Planning / Social Life (employment, peers, etc.)
- Protecting and Sustaining the Health of Young Adult with Intellectual Disabilities
- Coping with Stress
| Study group | Role | What they receive |
|---|---|---|
| Experimental: YEGEP group/Intervention | Experimental | Mothers will be informed about the program and invited to work. In the phone call, information will be given about the purpose, duration, requirements and volunteering of the study. The planned training schedule will be applied to these mothers. Receives: Other: Transition to Adulthood Education Program |
| Control group | No intervention | Annual care trainings are given to parents at the disabled center where the study will be conducted. There is no similar practice to these mothers on the same dates. place in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
The personal information form consists of various socio-demographic questions about the participant and the mentally handicapped child, such as gender, age and educational status.
Measured: All mothers will be asked to fill in 1 hour before the training.
Beach Center Family Quality of Life (BCFQOL) Scale
The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.
Measured: Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
Beach Center Family Quality of Life (BCFQOL) Scale
The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.
Measured: One month after the training is completed, mothers will be asked to complete this scale to evaluate the effectiveness of the training.
Perceived Stress Scale
The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.
Measured: Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
Perceived Stress Scale
The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.
Measured: Immediately afteImmediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.r the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2023
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587647
- Sponsor's protocol ID
- Eyşan Umac
- Status last verified
- Jan 2024
- First submitted
- 17 Oct 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transition to Adulthood Education Program Given to Mothers of Children With Intellectual Disability on Family Quality of Life and Perceived Stress Level
- ClinicalTrials.gov ID
- NCT05587647
- Acronym / sponsor ID
- Eyşan Umac
- Conditions
- Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 20 Oct 2022 (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.
Negative emotions experienced during life processes and the burden of caregiving affect the quality of life of parents. It has been found that parents who care for their children with intellectual disability (ID) for a long time have difficulties in coping with stress and their quality of life is adversely affected. However, families play a key role in maintaining the care of their children with ID, so it is very important that parents are supported in the matters they need.
Detailed description
Mothers are generally the people who take on a large part of the burden of care for their children with intellectual disability (ID) in the family and are most affected by the negativities brought by the conditions. Providing support to mothers for the care and future planning of their children who have just passed into adult life and for their future planning is important both in terms of maintaining family well-being and creating positive effects in the lives of individuals with mental disabilities.
With this study, it is aimed to increase the quality of life of mothers and to reduce perceived stress levels with the training (YEGEP) modules to be given for the changing care needs of individuals with ID who have reached adulthood or are in transition. In addition, it is expected that the health risks of young adults with ID will be determined at an early stage, and their health will be improved and protected.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Experimental: YEGEP group/Intervention | Experimental | Other: Transition to Adulthood Education ProgramMothers will be informed about the program and invited to work. In the phone call, information will be given about the purpose, duration, requirements and volunteering of the study. The planned training schedule will be applied to these mothers. |
| Control group | No intervention | –Annual care trainings are given to parents at the disabled center where the study will be conducted. There is no similar practice to these mothers on the same dates. place in the control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Whose child is registered with the disability center,
- Have a young adult child between the ages of 20 and 35 with moderate and severe mental disabilities,
- Speaking Turkish and literate Turkish,
- Not visually and speech impaired,
- Mothers who volunteered to participate in the study will be included.
Key exclusion criteria (1 listed)
- Mothers who did not volunteer to participate in the study and were illiterate in Turkish were not included in the study.
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 |
|---|---|---|
| Transition to Adulthood Education ProgramAlso: There is no other interventionYEGEP was developed by the authors based on the information in the literature, based on the needs of mothers of children who have reached adulthood or are going through. Three training modules are planned in line with current requirements. Education will also be supported by audio-visual and written materials. It is planned that the trainings, which will last for 3 weeks in total, for 1 hour a week for each group, in the form of 3 sessions of 1 hour with these contents, will be held at a disabled center. Titles of training modules: 1. Developmental Period Characteristics of Young Adults with Intellectual Disabilities (Transition to Adulthood, Future Planning / Social Life (employment, peers, etc.) 2. Protecting and Sustaining the Health of Young Adult with Intellectual Disabilities 3. Coping with Stress | Other | Experimental: YEGEP group/Intervention |
Primary outcome
Personal Information Form
Time frame: All mothers will be asked to fill in 1 hour before the training.
The personal information form consists of various socio-demographic questions about the participant and the mentally handicapped child, such as gender, age and educational status.
Beach Center Family Quality of Life (BCFQOL) Scale
Time frame: Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.
Beach Center Family Quality of Life (BCFQOL) Scale
Time frame: One month after the training is completed, mothers will be asked to complete this scale to evaluate the effectiveness of the training.
The scale, developed by University of Kansas Beach Center on Family and Disability (2006) (Beach Center on Disability at the University of Kansas in partnership with families, 2006) and adapted into Turkish by Meral et al. (2012), consists of 25 questions, five sub-dimensions and 5 It is a data collection tool consisting of likert-type responses. The scale aims to determine the quality of life of families with children with special needs.
Perceived Stress Scale
Time frame: Immediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.
Perceived Stress Scale
Time frame: Immediately afteImmediately after the training is completed (average of 5 minutes), mothers will be asked to complete this scale.r the training is completed (average of 5 minutes), mothers will be asked to complete this scale.
The scale developed by Cohen, Kamarck, and Mermelstein (1983) to measure how individuals evaluate stressful life events as unpredictable, uncontrollable and difficult to cope with in the last month consists of 10 items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition to Adulthood Education Program in people with Intellectual Disability, run by Koç University at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 11 Jan 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Personal Information Form (time frame: All mothers will be asked to fill in 1 hour before the training.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.