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

February 29, 2024 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

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

96

Phase

  • 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

  • Turkey
      • Konya, Turkey
        • Necmettin Erbakan University

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

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
Intervention / Treatment
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

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

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

Necmettin Erbakan University

Investigators

  • Study Director: Emine GEÇKİL, Prof. Dr., Necmettin Erbakan Univercity

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)

June 1, 2023

Primary Completion (Actual)

September 25, 2023

Study Completion (Estimated)

September 25, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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