PsychoeducationNCT06412328
Psychoeducation Program for Parents of Children with Duchenne Muscular Dystrophy
A study testing Psychoeducation in people with Psychoeducation and Parents, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Having and caring for a child with disabilities brings emotional, social and economic difficulties for many families. Families may experience many physiological and psychological problems due to the stress and anxiety they experience. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychoeducation, Parents, Psychological Wellness
- What is being tested?
- Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jun 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a child diagnosed with DMD
- Volunteering to participate in the study and reading and signing the informed consent form
Who cannot join
- Having previously or currently participated in any psychoeducation program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Lokman Hekim Universiyt
Ankara, Cankaya, 06510
About this study
Official title: The Effect of Psychosocial Support-based Psychoeducation Program on Psychiatric Symptoms, Stress Coping Styles and Social Support Perceptions of Families of Children and Adolescents Diagnosed with Duchenne Muscular Dystrophy
Having and caring for a child with disabilities brings emotional, social and economic difficulties for many families. Families may experience many physiological and psychological problems due to the stress and anxiety they experience. In addition, it is seen that families with children with disabilities give up their existing roles, reduce their participation in social activities, and reach stagnation in their social lives. Mothers are affected psychologically more than fathers and feel lonely. It is stated that mothers believe that they cannot afford everything in the face of the responsibilities they carry and accordingly, they experience emotional and psychological problems such as stress, anxiety, depression, absent-mindedness, forgetfulness and tantrums.
Living with a child with a disability causes family members to experience different emotions as mentioned above; families may frequently experience fear, anxiety, guilt, anger and depression. It is reported that mothers of children with DMD experience depression, anxiety about the future and uncertainty more than mothers of healthy children. Families of children with DMD reported that they felt tired and fatigued during the process of caring for the child and had difficulties in participating in social activities and allocating time for themselves. Most of these families stated that they needed psychological and social support. Therefore, it is important to address the psychiatric aspects of families with children with DMD during the disease process. Parental health contributes positively to the health and adaptation of the family in general. Examining the psychiatric symptoms caused by the problems experienced by families related to DMD and how they cope with this stress will be useful in evaluating and addressing these families. In addition, the social support that families with children with disabilities receive from their immediate environment and institutions is also an important issue. It has been reported that social support from relatives, friends, neighbors, organizations and communities increases the psychological resilience levels of families, they feel that they are not alone in the face of problems, and their anxiety levels decrease. In the literature, it is generally mentioned that when the culture of pediatric care is supportive and family-oriented, the care of the patient will undergo a change when transitioning from pediatric care to the adult period. However, studies evaluating the problems experienced by families in the care of patients with DMD, psychiatric symptoms, ways of coping with stress and perceived social support are insufficient. It is important to evaluate the problems experienced by parents in the families of children with DMD in developing skills to cope with the disease process and disease-related problems, and then to provide training in these areas. Because if parents, who are in the role of caregivers, are equipped with knowledge and skills in this context, they will provide better care and be more useful to their children with DMD.
In line with this information, the aim of this study was to evaluate the problems experienced by parents of children with DMD, psychiatric symptoms, coping skills with stress and the level of social support they perceive and to implement a psychosocial support-based psychoeducation program related to these areas.
- Being tested
- Psychoeducation
- Medical subject headings
- Psychological Well-Being, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationOther
The psychoeducation program based on psychosocial support is a total of 8 sessions. Families participating in the study received the psychoeducation program over 4 weeks, with two sessions per week, each session lasting 60 minutes. Parents were included in group work during the psychoeducation program.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The parents in the control group did not receive any psychoeducation program |
| Intervention group | Experimental | The parents in the intervention group received an 8-session psychoeducation program Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic information form
Measured: pre-intervention
Brief Symptom Inventory
It consists of five sub-dimensions (anxiety, depression, negative self, somatization and hostility) and 53 items. A high score in each sub-dimension indicates an increased level of discomfort in the person.
Measured: pre-intervention and immediately after the intervention
Coping with stress scale
The scale has five sub-dimensions: "self-confident approach", "optimistic approach", "helpless approach", "submissive approach" and "social support seeking approach". The scale consists of 30 items in total and is scored between 0-3. Each sub-dimension is scored separately. In the evaluation of the scale, an increase in the scores obtained from self-confident, optimistic and social support seeking approach means that effective stress coping methods are used, while an increase in the scores of helpless and submissive approach means that ineffective stress coping methods are used.
Measured: pre-intervention and immediately after the intervention
Multidimensional Scale of Perceived Social Support MSPSS
The scale consists of 12 items in total and has three sub-dimensions: "family support, friend support and special person support". The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score that can be obtained as a total scale score is 12 and the highest score is 84. A high score obtained from the scale means that the perceived social support is also high.
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start21 Jun 2023
- Primary completion29 Aug 2024
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychoeducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Pre-test - post-test, parallel, randomized controlled
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Başak Çağla Arslan, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412328
- Sponsor's protocol ID
- 2023109
- Status last verified
- Mar 2025
- First submitted
- 7 May 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be published in an article, but participants' information will be kept confidential. It will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychosocial Support-based Psychoeducation Program on Psychiatric Symptoms, Stress Coping Styles and Social Support Perceptions of Families of Children and Adolescents Diagnosed with Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT06412328
- Acronym / sponsor ID
- 2023109
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Having and caring for a child with disabilities brings emotional, social and economic difficulties for many families. Families may experience many physiological and psychological problems due to the stress and anxiety they experience. In addition, it is seen that families with children with disabilities give up their existing roles, reduce their participation in social activities, and reach stagnation in their social lives. Mothers are affected psychologically more than fathers and feel lonely. It is stated that mothers believe that they cannot afford everything in the face of the responsibilities they carry and accordingly, they experience emotional and psychological problems such as stress, anxiety, depression, absent-mindedness, forgetfulness and tantrums.
Living with a child with a disability causes family members to experience different emotions as mentioned above; families may frequently experience fear, anxiety, guilt, anger and depression. It is reported that mothers of children with DMD experience depression, anxiety about the future and uncertainty more than mothers of healthy children. Families of children with DMD reported that they felt tired and fatigued during the process of caring for the child and had difficulties in participating in social activities and allocating time for themselves. Most of these families stated that they needed psychological and social support. Therefore, it is important to address the psychiatric aspects of families with children with DMD during the disease process. Parental health contributes positively to the health and adaptation of the family in general. Examining the psychiatric symptoms caused by the problems experienced by families related to DMD and how they cope with this stress will be useful in evaluating and addressing these families. In addition, the social support that families with children with disabilities receive from their immediate environment and institutions is also an important issue. It has been reported that social support from relatives, friends, neighbors, organizations and communities increases the psychological resilience levels of families, they feel that they are not alone in the face of problems, and their anxiety levels decrease. In the literature, it is generally mentioned that when the culture of pediatric care is supportive and family-oriented, the care of the patient will undergo a change when transitioning from pediatric care to the adult period. However, studies evaluating the problems experienced by families in the care of patients with DMD, psychiatric symptoms, ways of coping with stress and perceived social support are insufficient. It is important to evaluate the problems experienced by parents in the families of children with DMD in developing skills to cope with the disease process and disease-related problems, and then to provide training in these areas. Because if parents, who are in the role of caregivers, are equipped with knowledge and skills in this context, they will provide better care and be more useful to their children with DMD.
In line with this information, the aim of this study was to evaluate the problems experienced by parents of children with DMD, psychiatric symptoms, coping skills with stress and the level of social support they perceive and to implement a psychosocial support-based psychoeducation program related to these areas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-test - post-test, parallel, randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The parents in the control group did not receive any psychoeducation program |
| Intervention group | Experimental | Other: PsychoeducationThe parents in the intervention group received an 8-session psychoeducation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a child diagnosed with DMD
- Volunteering to participate in the study and reading and signing the informed consent form
Key exclusion criteria (1 listed)
- Having previously or currently participated in any psychoeducation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoeducationThe psychoeducation program based on psychosocial support is a total of 8 sessions. Families participating in the study received the psychoeducation program over 4 weeks, with two sessions per week, each session lasting 60 minutes. Parents were included in group work during the psychoeducation program. | Other | Intervention group |
Primary outcome
Demographic information form
Time frame: pre-intervention
Brief Symptom Inventory
Time frame: pre-intervention and immediately after the intervention
It consists of five sub-dimensions (anxiety, depression, negative self, somatization and hostility) and 53 items. A high score in each sub-dimension indicates an increased level of discomfort in the person.
Coping with stress scale
Time frame: pre-intervention and immediately after the intervention
The scale has five sub-dimensions: "self-confident approach", "optimistic approach", "helpless approach", "submissive approach" and "social support seeking approach". The scale consists of 30 items in total and is scored between 0-3. Each sub-dimension is scored separately. In the evaluation of the scale, an increase in the scores obtained from self-confident, optimistic and social support seeking approach means that effective stress coping methods are used, while an increase in the scores of helpless and submissive approach means that ineffective stress coping methods are used.
Multidimensional Scale of Perceived Social Support MSPSS
Time frame: pre-intervention and immediately after the intervention
The scale consists of 12 items in total and has three sub-dimensions: "family support, friend support and special person support". The lowest score that can be obtained from the subscales is 4 and the highest score is 28. The lowest score that can be obtained as a total scale score is 12 and the highest score is 84. A high score obtained from the scale means that the perceived social support is also high.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No. The results of the study will be published in an article, but participants' information will be kept confidential. It will not be shared with other researchers.
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Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Psychoeducation and Parents, run by Lokman Hekim 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 2 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: enrolling by invitation, as of the sponsor's last update on 28 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?
This study is still under way. Results are not available in the source record yet.
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?
Demographic information form (time frame: pre-intervention). The study lists 4 primary outcomes in all. 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 28 Mar 2025.