NCT06862804

Brief 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 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

February 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 15, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2025

Enrollment Period

13 days

First QC Date

February 14, 2025

Last Update Submit

March 3, 2025

Conditions

Keywords

parentsspecial needs childself-compassionperceived social supportdepressive symptomsautismautism spectrum disorder

Outcome Measures

Primary Outcomes (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.

    Four Week

Secondary Outcomes (1)

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

    Four Week

Other Outcomes (2)

  • The severity of depressive symptoms will be measured with the Beck Depression Inventory for the effect of applied group training given to mothers of children with autism on depressive symptoms.

    four week

  • The self-compassion level of parents of autistic children will be measured with the self-compassion scale.

    Four Week

Study Arms (2)

Those receiving group training

EXPERIMENTAL

TThe 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.

Behavioral: practical group training

those who do not receive group training

ACTIVE COMPARATOR

no intervetion

Behavioral: practical group training

Interventions

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.

Those receiving group training

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kastamonu private educational institutions

Kastamonu, Central, 37100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum DisorderDepressionAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Havva KAÇAN, ASSOCIATE PROFESSOR DOCTOR

    Kastamonu University

    PRINCIPAL INVESTIGATOR
  • Şevval YEYİT, Research Assistant

    Kastamonu University

    STUDY CHAIR
  • Vasfiye Bayram Değer, ASSOCIATE PROFESSOR DOCTOR

    Mardin Artuklu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 6, 2025

Study Start

February 15, 2025

Primary Completion

February 28, 2025

Study Completion

March 2, 2025

Last Updated

March 6, 2025

Record last verified: 2025-02

Locations