Effect of Awareness-Based Stress Reducatıon Program Applıed to Parents Wıth A Chıld Wıth Autısm

August 24, 2026 updated by: Selverhan Yurttutan, Necmettin Erbakan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

  • Being a parent of a child with autism
  • Being literate and able to communicate in Turkish

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mindfulness-based stress reduction program
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.
Other: mindfulness-based stress reduction program
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.
No Intervention: control group
No application will be made.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
First assessment will be made at the baseline (pre-intervention)
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).
The second assessment will take place 8 weeks after the first assessment (after the program is completed).
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).
Third assessment will take place average 4 weeks after the second assessment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Hopelessness Scale (BUS)
Time Frame: First assessment will be made at the baseline (pre-intervention)
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".
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).
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".
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.
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".
Third assessment will take place average 4 weeks after the second assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Necmettin Erbakan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Emine GEÇKİL, Prof. Dr., Necmettin Erbakan Univercity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/410:13610

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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