DEPRESSIONNCT05877287
Effect of Awareness-Based Stress Reducatıon Program Applıed to Parents Wıth A Chıld Wıth Autısm
A study testing mindfulness-based stress reduction program in people with DEPRESSION and ANXIETY, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to examine the effect of mindfulness-based stress reduction program applied to parents with autistic children on the level of depression, anxiety, stress and hopelessness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DEPRESSION, ANXIETY, STRESS
- What is being tested?
- mindfulness-based stress reduction program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 25 Sep 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a parent of a child with autism
- Being literate and able to communicate in Turkish
Who cannot join
- Having a diagnosed mental and mental health problem
- Having a chronic, mental and mental health problem other than autism in a child with autism
- Having previously participated in a mindfulness-based stress reduction program
- Having another disabled child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mındfulness-Based Stress Reductıon Program Applıed to Parents Wıth A Chıld Wıth Autısm on The Level Of Depressıon, Anxıety, Stress and Hopelessness: Randomızed Controlled Trıal
This research was planned to examine the effect of mindfulness-based stress reduction program applied to parents with autistic children on the level of depression, anxiety, stress and hopelessness.
Read the detailed description
The program applied to parents with children with autism will be carried out once a week for 60 minutes, for 8 weeks, in 8 sessions in total. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. In the table indicating the general operation of the sessions within the scope of the research; The purpose, target, teaching method, material place, time, session content and application steps of each session will be given to the participants. Awareness-Based Stress Reduction Program Applied to Parents with Children with Autism will be given to the participants in the first week, including the important points of the program, prepared by the researchers, and expert opinions will be taken.
- Conditions
- DEPRESSION, ANXIETY, STRESS, HOPELESSNESS, MİNDFULNESS
- Being tested
- mindfulness-based stress reduction program
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based stress reduction programOther
The FTSA program will be carried out once a week for 60 minutes, for 8 weeks, in a total of 8 sessions. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based stress reduction program | Experimental | The FTSA program will be carried out once a week for 60 minutes, for 8 weeks, in a total of 8 sessions. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. Receives: Other: mindfulness-based stress reduction program |
| control group | No intervention | No application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale (DASS-21)
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
Measured: First assessment will be made at the baseline (pre-intervention)
Depression, Anxiety and Stress Scale (DASS-21)
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
Measured: The second assessment will take place 8 weeks after the first assessment (after the program is completed).
Depression, Anxiety and Stress Scale (DASS-21)
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
Measured: Third assessment will take place average 4 weeks after the second assessment.
Secondary outcomes (3)
Beck Hopelessness Scale (BUS)
It was developed to determine the degree of pessimism of the individual for the future. The scale, which consists of a total of 20 items, is scored between 0-1 and is a self-assessment type scale. It can also be applied as a group. It is a scale that can be easily applied to literate children, young people and adults without time limit. The scale is evaluated in three sub-dimensions regarding the future (Future Emotions, Loss of Motivation, Future Expectations). 20 items in the scale are answered as "Yes and No", each inconsistent answer is scored with 0 and each compatible answer with 1 point. "yes" to eleven items (2, 4, 7, 9, 11, 12, 14, 16, 17, 18, 20) and 9 items (1, 3, 5, 6, 8, 10, 13, 15, 19) "no" answer is evaluated with 1 point. A high total score (in the range of 0-20) is considered as "high level of hopelessness".
Measured: First assessment will be made at the baseline (pre-intervention)
Beck Hopelessness Scale (BUS)
It was developed to determine the degree of pessimism of the individual for the future. The scale, which consists of a total of 20 items, is scored between 0-1 and is a self-assessment type scale. It can also be applied as a group. It is a scale that can be easily applied to literate children, young people and adults without time limit. The scale is evaluated in three sub-dimensions regarding the future (Future Emotions, Loss of Motivation, Future Expectations). 20 items in the scale are answered as "Yes and No", each inconsistent answer is scored with 0 and each compatible answer with 1 point. "yes" to eleven items (2, 4, 7, 9, 11, 12, 14, 16, 17, 18, 20) and 9 items (1, 3, 5, 6, 8, 10, 13, 15, 19) "no" answer is evaluated with 1 point. A high total score (in the range of 0-20) is considered as "high level of hopelessness".
Measured: The second assessment will take place 8 weeks after the first assessment (after the program is completed).
Beck Hopelessness Scale (BUS)
It was developed to determine the degree of pessimism of the individual for the future. The scale, which consists of a total of 20 items, is scored between 0-1 and is a self-assessment type scale. It can also be applied as a group. It is a scale that can be easily applied to literate children, young people and adults without time limit. The scale is evaluated in three sub-dimensions regarding the future (Future Emotions, Loss of Motivation, Future Expectations). 20 items in the scale are answered as "Yes and No", each inconsistent answer is scored with 0 and each compatible answer with 1 point. "yes" to eleven items (2, 4, 7, 9, 11, 12, 14, 16, 17, 18, 20) and 9 items (1, 3, 5, 6, 8, 10, 13, 15, 19) "no" answer is evaluated with 1 point. A high total score (in the range of 0-20) is considered as "high level of hopelessness".
Measured: Third assessment will take place average 4 weeks after the second assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jun 2023
- Primary completion25 Sep 2023
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DEPRESSIONStudies 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
- parallel group (experiment-control) randomized controlled experimental
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selverhan Yurttutan, Necmettin Erbakan University
- Investigators
- Emine GEÇKİL, Prof. Dr., Study director, Necmettin Erbakan Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877287
- Sponsor's protocol ID
- 2023/410:13610
- Status last verified
- Aug 2026
- First submitted
- 15 May 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mındfulness-Based Stress Reductıon Program Applıed to Parents Wıth A Chıld Wıth Autısm on The Level Of Depressıon, Anxıety, Stress and Hopelessness: Randomızed Controlled Trıal
- ClinicalTrials.gov ID
- NCT05877287
- Acronym / sponsor ID
- 2023/410:13610
- Conditions
- DEPRESSION, ANXIETY, STRESS, HOPELESSNESS, MİNDFULNESS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 26 May 2023 (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.
This research was planned to examine the effect of mindfulness-based stress reduction program applied to parents with autistic children on the level of depression, anxiety, stress and hopelessness.
Detailed description
The program applied to parents with children with autism will be carried out once a week for 60 minutes, for 8 weeks, in 8 sessions in total. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. In the table indicating the general operation of the sessions within the scope of the research; The purpose, target, teaching method, material place, time, session content and application steps of each session will be given to the participants. Awareness-Based Stress Reduction Program Applied to Parents with Children with Autism will be given to the participants in the first week, including the important points of the program, prepared by the researchers, and expert opinions will be taken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- parallel group (experiment-control) randomized controlled experimental
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based stress reduction program | Experimental | Other: mindfulness-based stress reduction programThe FTSA program will be carried out once a week for 60 minutes, for 8 weeks, in a total of 8 sessions. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. |
| control group | No intervention | –No application will be made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being a parent of a child with autism
- Being literate and able to communicate in Turkish
Key exclusion criteria (4 listed)
- Having a diagnosed mental and mental health problem
- Having a chronic, mental and mental health problem other than autism in a child with autism
- Having previously participated in a mindfulness-based stress reduction program
- Having another disabled child
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 |
|---|---|---|
| mindfulness-based stress reduction programThe FTSA program will be carried out once a week for 60 minutes, for 8 weeks, in a total of 8 sessions. The program will be conducted in face-to-face groups. Sessions will be held in a suitable area in the practice area. In each 60-minute session, it is planned to be 20 minutes of narration on the subject of the session, accompanied by a power point presentation, and the remaining 40 minutes of exercise, meditation practices and sharing experiences. | Other | mindfulness-based stress reduction program |
Primary outcome
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: First assessment will be made at the baseline (pre-intervention)
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: The second assessment will take place 8 weeks after the first assessment (after the program is completed).
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Third assessment will take place average 4 weeks after the second assessment.
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension (Sarıçam, 2018).
3 secondary outcomes
Beck Hopelessness Scale (BUS)
Time frame: First assessment will be made at the baseline (pre-intervention)
Beck Hopelessness Scale (BUS)
Time frame: The second assessment will take place 8 weeks after the first assessment (after the program is completed).
Beck Hopelessness Scale (BUS)
Time frame: Third assessment will take place average 4 weeks after the second assessment.
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 26 Aug 2026.
- Publication of the results of this clinical trialLink provided by the sponsor.
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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.
Emine GEÇKİL, Prof. Dr. study director
Necmettin Erbakan Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based stress reduction program in people with DEPRESSION and ANXIETY, run by Necmettin Erbakan 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 2 inclusion and 4 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 26 Aug 2026. 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?
Depression, Anxiety and Stress Scale (DASS-21) (time frame: First assessment will be made at the baseline (pre-intervention)). The study lists 3 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 26 Aug 2026.