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

Primary Purpose

DEPRESSION, ANXIETY, STRESS

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
mindfulness-based stress reduction program
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for DEPRESSION

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Necmettin Erbakan ÜniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mindfulness-based stress reduction program

control group

Arm Description

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 application will be made.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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".
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".
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".

Full Information

First Posted
May 15, 2023
Last Updated
August 4, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05877287
Brief Title
Effect of Awareness-Based Stress Reducatıon Program Applıed to Parents Wıth A Chıld Wıth Autısm
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 25, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DEPRESSION, ANXIETY, STRESS, HOPELESSNESS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel group (experiment-control) randomized controlled experimental
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mindfulness-based stress reduction program
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No application will be made.
Intervention Type
Other
Intervention Name(s)
mindfulness-based stress reduction program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
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).
Time Frame
First assessment will be made at the baseline (pre-intervention)
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
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).
Time Frame
The second assessment will take place 8 weeks after the first assessment (after the program is completed).
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
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).
Time Frame
Third assessment will take place average 4 weeks after the second assessment.
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale (BUS)
Description
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".
Time Frame
First assessment will be made at the baseline (pre-intervention)
Title
Beck Hopelessness Scale (BUS)
Description
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".
Time Frame
The second assessment will take place 8 weeks after the first assessment (after the program is completed).
Title
Beck Hopelessness Scale (BUS)
Description
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".
Time Frame
Third assessment will take place average 4 weeks after the second assessment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine GEÇKİL, Prof. Dr.
Organizational Affiliation
Necmettin Erbakan Univercity
Official's Role
Study Director
Facility Information:
Facility Name
Necmettin Erbakan Üniversity
City
Konya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selverhan Yurttutan, research
Phone
0905072834903
Email
selverhan@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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