NCT05877287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2025

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

May 15, 2023

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    Third assessment will take place average 4 weeks after the second assessment.

Secondary Outcomes (3)

  • Beck Hopelessness Scale (BUS)

    First assessment will be made at the baseline (pre-intervention)

  • Beck Hopelessness Scale (BUS)

    The second assessment will take place 8 weeks after the first assessment (after the program is completed).

  • Beck Hopelessness Scale (BUS)

    Third assessment will take place average 4 weeks after the second assessment.

Study Arms (2)

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.

Other: mindfulness-based stress reduction program

control group

NO INTERVENTION

No application will be made.

Interventions

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.

mindfulness-based stress reduction program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversity

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Emine GEÇKİL, Prof. Dr.

    Necmettin Erbakan Univercity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: parallel group (experiment-control) randomized controlled experimental
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 26, 2023

Study Start

June 1, 2023

Primary Completion

September 25, 2023

Study Completion

September 25, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations