NCT05693662

Brief Summary

Autistic Spectrum Disorder (ASD) is an important public health problem in our country as well as all over the world. The physical, psychological, social and economic problems and mood disorders experienced by the parents of these children can negatively affect not only themselves, but also the effectiveness of the intervention and treatment programs applied to the children. Therefore, many mindfulness-based intervention programs aim to improve stress reduction, resilience and well-being in parents. In this study, it is aimed to evaluate the effect of mindfulness-based self-compassion training given to parents of children with ASD on stress, resilience and well-being. The research will be carried out with the parents of children aged 7-12 years who applied to the Child and Adolescent Psychiatry Outpatient Clinic of Atatürk University Health Research and Application Center located in Erzurum city center between December 2022 and October 2024 and diagnosed with ASD. The sample of the study was determined by G-power analysis. With the power analysis, it was calculated that at least 68 parents should be included in the sample, in the calculation made at the level of α=0.05, the effect size of 150, 153 (d=0.8) and the power of the study to be 90%. Therefore, the sample size of this study is planned to be 68. In the collection of research data, an introductory information form containing the socio-demographic data of the child with ASD and the parent, prepared by the researcher in line with the literature, Parental Stress Scale (SIDS), Psychological Resilience Scale for Adults, Warwick-Edinburgh Mental Well-Being Scale, Self-Compassion Scale Short Form (SSS-F), Conscious Awareness Scale (CIFI) will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

27 days

First QC Date

January 12, 2023

Last Update Submit

June 3, 2024

Conditions

Keywords

Awareness, well-being, self-compassion, resilience, stress

Outcome Measures

Primary Outcomes (6)

  • Introductory Information Form

    The form consists of 15 questions containing information about the child and his/her parents, created by the researcher within the scope of the literature. The created form includes questions about mother's age, father's age, child's age, age at which the child was diagnosed with ASD, child's gender, child's education level, number of siblings of the child, mother's education level, father's educational status, information about the parents' relationship, and the parent's mental state.

    up to 24 hours

  • Parental Stress Scale (PASS)

    It was developed by Özmen and Özmen (2012) to measure the stress experienced by mothers and fathers in their relationships with their children in daily life. ABSQ consists of a single factor structure consisting of 16 items. The Cronbach alpha coefficient of the scale is .85. The scale is a four-point Likert type (Always=4, Often=3, Sometimes=2, Never=1). The lowest score that can be obtained from the scale is 16, and the highest score is 64. A high score from the scale indicates that parental stress is high.

    up to 24 hours

  • Resilience Scale for Adults

    The dimensions in the scale are called 'self-perception', 'perception of the future', 'structural style', 'social competence', 'family cohesion' and 'social resources'. In the scale, which includes a total of 33 items, a format is used in which positive and negative features are on different sides, and five separate boxes are used for answers in order to avoid biased evaluations in choosing the items. In the schematic evaluation, the scoring method was released in the high or low measurement of psychological resilience.Cronbach Alpha values calculated for the reliability of the scale; It was calculated as 0.76 for 'Self Perception', 0.75 for 'Future Perception', 0.84 for 'Social Competence', 0.89 for 'Family Cohesion', 0.80 for 'Social Resources' and 0.76 for 'Structural Style.

    up to 24 hours

  • Warwick-Edinburgh Mental Well-Being Scale

    Tennant et al. (2007) and adapted into Turkish by Keldal (2015). Consisting of 14 items and a single dimension, this scale covers psychological well-being and subjective well-being and deals with the positive mental health of individuals. The scale is a 5-point Likert type, with a scoring of 1 = strongly disagree, 2 = disagree, 3 = somewhat agree, 4 = agree, 5 = completely agree. A minimum of 14 and a maximum of 70 points are obtained from the scale. High scores obtained from the scale indicate high mental (psychological) well-being. All items of the scale are positive. Cronbach's Alpha internal consistency reliability coefficient was found to be 0.92.

    up to 24 hours

  • Self-Compassion Scale Short Form (STS-C)

    The scale developed by Neff (2003) was validated and reliable in Turkish by Yıldırım and Sarı in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. Neff (2014) used the scale he developed in parents with children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. SSS-F It is recommended to be used in studies where total score will be used to measure self-compassion.

    up to 24 hours

  • Conscious Awareness Scale (CIFS)

    It was developed by Brown and Ryan (2003) in order to evaluate the CP level of individuals. In the study of Ozgreen et al. (2011), its Turkish validity and reliability were performed. The scale is a one-dimensional, six-point Likert-type scale consisting of 15 questions. The Cronbach's alpha coefficient of the scale was found to be 0.80. The minimum and maximum points that individuals can get from the scale are between 15 and 90. High scores indicate a high BF level.

    up to 24 hours

Study Arms (10)

Session 1

EXPERIMENTAL

Educational About Autism Spectrum Disorder

Behavioral: Session 1

Session 2

EXPERIMENTAL

Mindfulness Based Self-Compassion information

Behavioral: Session 2

Session 3

EXPERIMENTAL

How We Evolved - Threat, Impulse, and Soothing Systems

Behavioral: Session 3

Session 4

EXPERIMENTAL

Threat and Self-Compassion

Behavioral: Session 4

Session 5

EXPERIMENTAL

Untying the Knots of Desires and Patterns

Behavioral: Session 5

Session 6

EXPERIMENTAL

Internalize compassion

Behavioral: Session 6

Session 7

EXPERIMENTAL

Me and others - Widening the circle

Behavioral: Session 7

Session 8

EXPERIMENTAL

Growing happiness

Behavioral: Session 8

Session 9

EXPERIMENTAL

Weaving Wisdom and Compassion into Daily Life

Behavioral: Session 9

Session 10

EXPERIMENTAL

Living with Heart

Behavioral: Session 10

Interventions

Session 1BEHAVIORAL

* Ensuring group interaction, allowing parents to meet each other, * Providing information in line with the "Awareness-Based Self-Compassion Training Booklet for Parents of Children with Autism Spectrum Disorder" prepared as training material,

Session 1
Session 2BEHAVIORAL

* Making explanations about the contents of the training sessions to be held with parents, * Teaching proper breathing techniques, * Visual demonstration and application of relaxation techniques

Session 2
Session 3BEHAVIORAL

* "Breathing break with kindness" application, * Thinking and evaluating how threat, impulse and soothing systems develop in individuals' own lives, * "Safe place" application, * Applying "kindness meditation",

Session 3
Session 4BEHAVIORAL

* "Breathing break with kindness" application, * The practice of "establishing a compassionate relationship with resistance", * "Kindness meditation: a do-gooder" application, * "A hand on the heart" application, * "A compassionate companion" application,

Session 4
Session 5BEHAVIORAL

* "Breathing break with kindness" application, * The practice of "establishing a compassionate relationship with desire", * "Guided meditation to discover the inner pattern" practice, * "Kindness meditation: a good friend" application,

Session 5
Session 6BEHAVIORAL

* "Pretending" practice regarding parents' awareness, * An expanded version of the practices carried out in previous sessions to raise awareness, the "internalizing compassion" practice, * "Kindness meditation: a neutral person", "kindness towards your body" and "walking with kindness" practices, which are based on mindfulness practices and increase body awareness and mindful movement,

Session 6
Session 7BEHAVIORAL

* A "compassionate letter" application, which is carried out by asking parents to think about a situation they have encountered recently or some time ago that still causes distress, * "Kindness meditation: the 'difficult' person", "compassion and breathing: yourself" and "compassionate breathing: others" practices, * Researching how parents can cope with difficulties and implementing a "compassionate breath break" without words,

Session 7
Session 8BEHAVIORAL

* "Revisiting the good" application to enable parents to experience the five senses in a pleasant way, * Practices of "self-forgiveness", "asking for forgiveness", "forgiving others", "gratitude", which can be a way of mending the cracks in parents' relationships with themselves and others, * Expanding the practice into "kindness meditation: groups and all beings",

Session 8
Session 9BEHAVIORAL

* The practice of allowing parents to choose a day in their lives for a few minutes to pause mindfully, * "A breather for wise and compassionate action" practice, * "Calmness meditation" application, * "Sharing the joy meditation" application,

Session 9
Session 10BEHAVIORAL

* Evaluating the entire education by telling parents about the practices they can use where help is needed to develop compassion towards self-healing skills, * "River of Life" application, which evaluates awareness in depth, * Saying goodbye.

Session 10

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be at least a primary school graduate.
  • Being the parent of a child whose age is 7-12 and diagnosed with ASD.
  • Willingness to participate in the study.
  • To be open to communication and cooperation.

You may not qualify if:

  • Parental psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • DİLEK KILIÇ

    Atatürk University, Faculty of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
It was not stated to the parents whether they were in the experimental or control group. It was performed in a single blind manner.The statistician is also blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: For randomization, parents were randomly assigned to experiment and control by using a computer program module used in randomized controlled studies (https://www.random.org/). Parents of children with ASD are numbered in the order in which they arrived at the hospital. This process was carried out until the experimental and control groups were completed. Parents of children with ASD included in the study were randomized using a single-blind randomization rule. Parents who met the sampling criteria for randomization were ranked up to 68.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

February 1, 2023

Primary Completion

February 28, 2023

Study Completion

March 5, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations