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Autism Spectrum DisorderNCT06862804

The Effect of Applied Group Training Given to Mothers With Children With Autism on Perceived Social Support, Depressive Symptoms and Self-compassion

A study testing practical group training in people with Autism Spectrum Disorder and Parent, run by Kastamonu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Autism Spectrum Disorder (ASD), which can also be defined as a type of special need, is a congenital neurodevelopmental disorder whose symptoms are observed in early childhood. ASD, which has deficits in social communication and interaction as well as limited-repetitive behaviour patterns, starts in the early… Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Autism Spectrum Disorder, Parent
What is being tested?
practical group training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2025to 2 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Being a parent of a child diagnosed with autism spectrum disorder between the ages of 1-18
  • To have assumed the responsibility of giving primary care to the child with autism,
  • Having provided care for at least 6 months,

Who cannot join

  • 1-Mental or physical disability, 2-Having participated in a similar training programme before

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kastamonu private educational institutions

    Kastamonu, Central, 37100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Applied Group Training Given to Mothers With Children With Autism on Perceived Social Support, Depressive Symptoms and Self-compassion: A Randomised Controlled Trial

Autism Spectrum Disorder (ASD), which can also be defined as a type of special need, is a congenital neurodevelopmental disorder whose symptoms are observed in early childhood. ASD, which has deficits in social communication and interaction as well as limited-repetitive behaviour patterns, starts in the early developmental stage and causes a significant impairment in areas of social functioning .

A child with autism causes serious anxiety and depression in the family for many reasons, including the uncertainty of the diagnosis, the severity and duration of the disorder, and the child's lack of compliance with social rules. ASD has devastating effects not only on the individual but also on carers . It is reported that mothers with a child with ASD experience psycho-social difficulties compared to parents with a normally developing child . Hyperactivity, mood problems, disturbances in sleep and eating patterns, obsessions and compulsive behaviours, and self-injurious behaviours of children with ASD make the parent-child relationship difficult. Due to the burden of care brought about by such findings and difficulties, the family begins to experience situations such as decreased quality of relationship between family members, educational problems, financial difficulties and future anxiety. There is a significant relationship between emotional and behavioural problems of children with ASD and anxiety and depression levels of their parents.

Read more

In addition to psychological symptoms, caregiver parents also experience limitations in daily life activities. The ability of mothers with children with autism to cope with unexpected situations is closely related to the social support they perceive. However, studies show that parents with children with autism have difficulties in entering and adapting to the society, and therefore, friends, neighbours and close environment relations from which they can get social support are weakened. Considering that supporting these families, especially mothers, both socially and spiritually can be important in alleviating the difficulties they experience and that mothers with autistic children are in a risk group in terms of receiving this support, it is understood how important the issue is.

Self-compassion is the individual's directing compassionate behaviours and attitudes towards himself/herself. Neff defines self-compassion as individuals being kind and compassionate towards themselves in difficult situations of inadequacy, failure and pain, accepting their negative emotions by being aware of them, and knowing that all kinds of challenging situations that can be experienced are related to being human. Self-compassion is recognised as one of the healthy ways of coping with difficult experiences and pain. It is stated that self-compassion is positively associated with coping strategies such as active coping, acceptance and reorganisation, and negatively associated with coping strategies such as mental-behavioural dissolution or rejection. In the findings of self-compassion-based studies conducted with parents who have children with disabilities in the literature, it was reported that as the level of self-compassion increases, parents' optimism levels increase, self-compassion has a negative relationship with burnout and a positive relationship with subjective well-being, and positive coping strategies increase as the level of self-compassion increases.

H0: The applied training programme has no effect on perceived social support, depressive symptoms and self-compassion.

H1: The applied training programme has an effect on perceived social support, depressive symptoms and self-compassion.

Sample of the research:The population of the study consists of caregivers who have children between the ages of 6-18 years with autism diagnosed with autism who are educated in 3 special education and rehabilitation centres in Kastamonu province and who undertake their primary care. Caregivers who brought their children to these centres for the purpose of education, who meet the research criteria and who voluntarily accept to participate in the research will be included in the sample. Power analysis was performed with the G*Power 3.1 programme to determine the number of people to be included in the sample, and it was planned to include 48 caregivers, 24 in the experimental group and 24 in the control group.

Read the detailed description
  • Data Collection Tool: Data collection tools consist of four parts.
  1. Descriptive characteristics form: It consists of eight questions about the descriptive characteristics of the child with autism and the caregiver, including questions about the caregiver's age, gender, education level, and problems encountered in care.
  2. Multidimensional Perceived Social Support Scale: The original form was developed by Zimet et al. (1988) in the United States of America and its adaptation to Turkish, reliability and validity study was conducted by Eker, Arkar, Yaldız (2001). With the Multidimensional Perceived Social Support Scale, the adequacy of social support received from three different sources is subjectively evaluated. The Likert-type scale, which is scored from 1 to 7, ranges from 4 to 28 for the sub-dimensions and from 12 to 84 for the total score of the scale. A high score indicates that the perceived social support is high.
  3. Beck Depression Inventory: It was developed in 1978 by Beck et al. to measure depression levels of individuals. Beck Depression Inventory is a frequently used inventory that measures emotional, physical, cognitive and motivational symptoms of depression. The purpose of the Beck Depression Inventory is not to diagnose but to objectively measure the depression level of the individual. Its Turkish validity and reliability was carried out by Durak and Palabıyıkoğlu in 1994. Each of the subcategories in the scale consists of 4 items and is graded with 0 to 3 points. A maximum score of 63 and a minimum score of 0 can be obtained. Scores between 0-9 points are considered as normal, 16-23 as moderate depression, 24-63 as severe depression.
  4. Self-Compassion Scale: It is a self-report scale developed by Neff (2003) and adapted to Turkish by Akın et al. (2007). It consists of a total of 6 sub-dimensions and 26 items: Self-Compassion, Self-Judgement, Awareness of Sharing, Isolation, Consciousness and Overidentification. The score of the 5-point Likert-type scale varies between 26 and 130. Since selfjudgement, isolation and overidentification are negative subscales, their items are reverse coded. The averages of the six subscales give the total mean of self-compassion. Mean scores between 1-2.5 indicate low level of self-compassion, scores between 2.5-3.5 indicate medium level of self-compassion and scores between 3.5-5 indicate high level of self-compassion. The internal consistency coefficients of the scale were found between .72 and .80. Data Collection Process The data will be collected face-to-face by the researchers when the caregivers bring their children to their institutions. In the preliminary preparation phase; the author (HK) will inform the unit managers of the centres where the study will be conducted about the aims of the study and the application processes, the personal data form and scales will be applied by the researcher in a quiet classroom environment, after the individuals to be included in the experimental and control groups are determined, the preliminary data will be collected from both groups before the training is given. The group training programme will be completed in six consecutive weeks, two per week, and the caregivers will be divided into two groups of 12 people with the support of the school administration according to their arrival to the school. The first group will be organised on Tuesday and the second group on Friday. For those who cannot attend both groups, weekly training will be given on Saturdays. Each group session will last 45-60 minutes, the first 10 minutes will be spent summarising the previous session, 40 minutes will be spent implementing the plan in line with the session topic, the last 10 minutes will be spent evaluating and summarising the session and ending the session by explaining the next session topic. No application will be made to the individuals in the control group during the study. The pretest scales will be applied individually by the researchers when the participants come to the unit to give information about the study and to obtain voluntary consent. The post-test will be administered six weeks after the pre-test at the same place and by the same researchers. Sessions <!-- -->
  5. Meeting with the group members, introduction of the group process, explanation of the session topics,
  6. Difficulties in caring for a child with autism and coping behaviours
  7. Self-Compassionate approach training practices
  8. I discover my strengths through painting activities for the recognition and expression of emotions.
  9. Gaining Positive Health Behaviours: Interpersonal communication and using supports, anger management
  10. Gaining Positive Health Behaviours: Managing Stress, Progressive relaxation techniques and taking questions
  • Data Analysis:

The data obtained in the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 programme. Number, percentage, mean, standard deviation will be used as descriptive statistical methods in the evaluation of the data. The homogeneity of the descriptive characteristics according to the groups will be analysed by chi-square and t-test. The kurtosis and skewness values related to the normal distribution of the scale scores will be examined and the reference value ranges (+2.0 and -2.0; George, \& Mallery, 2010) will be determined, the difference of the scale scores between the groups will be analysed by independent samples t-test and the change within the group will be analysed by dependent samples t-test (paired samples). Cronbach's alpha values will be calculated when calculating the reliability coefficients of the scales. For all statistical analyses, the significance level will be accepted as p<0.05.

Being tested
practical group training
Keywords
parents, special needs child, self-compassion, perceived social support, depressive symptoms, autism, autism spectrum disorder
Medical subject headings
Autism Spectrum Disorder, Depression, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • practical group trainingBehavioural

    It is understood how important the issue is when it is considered that supporting these families, especially mothers, both socially and psychologically can be important in alleviating the difficulties they experience and that mothers with children with autism are in a risk group in terms of receiving this support. The research was designed considering that the applied training we will provide will be effective in increasing social support and developing self-compassion for the primary caregivers of children and will reduce the level of depressive symptoms.

  • practical group trainingBehavioural

    practical group training

Study groups in NCT06862804
Study groupRoleWhat they receive
Those receiving group trainingExperimentalTThe group training programme will be completed in six consecutive weeks, two per week, and the caregivers will be divided into two groups of 12 people with the support of the school administration according to their attendance at the school. The first group will be organised on Tuesday and the second group on Friday. For those who cannot attend both groups, weekly training will be given on Saturdays. Each group session will last 45-60 minutes, the first 10 minutes will be spent summarising the previous session, 40 minutes will be spent implementing the plan in line with the session topic, the last 10 minutes will be spent evaluating and summarising the session and ending the session by explaining the next session topic. No application will be made to the individuals in the control group during the study. The pretest scales will be applied individually by the researchers when the participants come to the unit to give information about the study and to obtain voluntary consent.
Receives: Behavioral: practical group training
those who do not receive group trainingActive comparatorno intervetion
Receives: Behavioral: practical group training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of the implemented training program on Perceived Social Support will be measured.

    The effect of the implemented training program on Perceived Social Support and its level will be measured with the Perceived Social Support scale.

    Measured: Four Week

Secondary outcomes (1)
  1. The psychosocial status assessment level of parents will be measured with the Psychosocial Status Assessment Scale for Parents (1-3 years).

    The psychosocial status assessment level of parents will be measured with the Psychosocial Status Assessment Scale for Parents (1-3 years).

    Measured: Four Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start15 Feb 2025
  3. Primary completion28 Feb 2025
  4. Study completion2 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The data obtained in the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 programme. Number, percentage, mean, standard deviation will be used as descriptive statistical methods in the evaluation of the data. The homogeneity of the descriptive characteristics according to the groups will be analysed by chi-square and t-test. The kurtosis and skewness values related to the normal distribution of the scale scores will be examined and the reference value ranges (+2.0 and -2.0; George, \& Mallery, 2010) will be determined, the difference of the scale scores between the groups will be analysed by independent samples t-test and the change within the group will be analysed by dependent samples t-test (paired samples). Cronbach's alpha values will be calculated when calculating the reliability coefficients of the scales. For all statistical analyses, the significance level will be accepted as p\<0.05.
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06862804
Sponsor's protocol ID
2024-KAEK-117
Other IDs
2024-KAEK-117
Status last verified
Feb 2025
First submitted
14 Feb 2025
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing practical group training in people with Autism Spectrum Disorder and Parent, run by Kastamonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of the implemented training program on Perceived Social Support will be measured. (time frame: Four Week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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