AutismNCT06629974
The Effects of an Empowerment Program for Parents of Children With Autism
A study testing Parental empowerment program in people with Autism and Parenting, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of an empowerment program that includes both parent training and motivational interviewing for parents of children with autism, supporting their competence in the care of their children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autism, Parenting, Motivational Interviewing
- What is being tested?
- Parental empowerment program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2020to 23 Dec 2022
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion criteria were having a child diagnosed with ASD between the ages of 6 and 14, being literate, and volunteering to participate in the study.
Who cannot join
- Having a child with a concomitant disability or disease (e.g., epilepsy, attention deficit, and hyperactivity disorder, other physical or mental disabilities), previous participation in an education program with similar content, or parents who did not participate in at least two-thirds of the empowerment training program or did not attend all motivational interview sessions were excluded from the study, and their data were not included in the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of an Empowerment Program for Parents of Children With Autism: A Randomised Controlled Trial
This study aims to evaluate the effectiveness of an empowerment program that includes both parent training and motivational interviewing for parents of children with autism, supporting their competence in the care of their children.
Read the detailed description
This study was conducted to evaluate the effectiveness of an empowerment program for parents of children with autism to support their competence in caring for their children. This randomized controlled study was conducted in Manisa city center/Turkey, in 2022. A total of 69 parents (intervention: 34, control: 35) were included in this unblinded, two-group randomized controlled interventional study. A parent empowerment program, including four parental training sessions and two motivational interview sessions, were applied to the parents in the intervention group. The Parental Self-Efficacy Scale, Zarit Care Burden Scale, Perceived Stress Scale, and Family Empowerment Scale were used to evaluate the effectiveness of the empowerment program.
- Conditions
- Autism, Parenting, Motivational Interviewing
- Being tested
- Parental empowerment program
- Keywords
- Autism, Parent training, Empowerment, Parental self-efficacy, Parental stress, Care burden
- Medical subject headings
- Autistic Disorder, Empowerment, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental empowerment programBehavioural
The empowerment program consisted of two parts: the empowerment training program for parents and motivational interviews.
The empowerment training program was prepared to enable parents to carry out the care process more effectively in areas where parents have difficulties caring for their children with autism. Within the scope of the empowerment training program, parents were trained on the importance of play and communication, problems and management in the field of nutrition, sleep problems and management, safety and protection from accidents, and problems and management in the field of self-care.
Ten days after the empowerment training program, two face-to-face motivational interviews were conducted with each participant in the intervention group. Each participant had a one-week break between the first and second motivational interviews. Each motivational interview session lasted approximately 25-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this group were administered the pre-intervention introductory information form, The Parental Self-Efficacy Scale, the Zarit Care Burden Scale, the Perceived Stress Scale and the Family Empowerment Scale. Then, a group empowerment training program consisting of four sessions in total was applied to the participants. Two motivational interview sessions were conducted with each participant in the intervention group 10 days after the empowerment training program. One month after the motivational interview sessions were completed, post-test data were collected. Receives: Behavioral: Parental empowerment program |
| Control group | No intervention | No intervention was applied to the control group. The data collection tools applied to the intervention group in the pre-test and post-test were also applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The parental self-efficacy scale scores
The scale was developed by Guimond et al. (2005) to measure the self-efficacy of parents of children with disabilities regarding parenting skills (Guimond et al., 2005). The Turkish adaptation of the scale was first made by Diken (2007) and then by Cavkaytar et al. (2014) (Cavkaytar et al., 2014; Diken, 2007). The Parental Self-Efficacy Scale is a seven-point Likert-type rating scale consisting of 17 items. The lowest and highest values that can be taken from the scale are 17 and 119. Higher scores indicate higher self-efficacy perceptions. The Cronbach Alpha internal consistency coefficient value of the scale was calculated as 0.95 (Cavkaytar et al., 2014). The Cronbach's Alpha internal consistency coefficient value of the scale in this study is 0.96.
Measured: Three months
The zarit care burden scale scores
The Zarit Care Burden Scale was developed by Zarit et al. in 1980 and adapted to Turkish by Inci and Erdem (2006). The scale is a 22-item, five-point Likert-type scale used to evaluate the stress experienced by caregivers of individuals in need of care. A minimum score of 0 and a maximum score of 88 can be obtained from the scale. The higher the score obtained from the scale, the higher the care burden felt. The Cronbach's Alpha internal consistency coefficient value of the scale was found to be 0.75 in the original study (Inci and Erdem, 2006; Zarit et al., 1980) and 0.89 in this study.
Measured: Three months
The perceived stress scale scores
The Perceived Stress Scale was developed by Cohen et al. (1983) and adapted into Turkish by Eskin et al. This 14-item, five-point Likert-type scale has two sub-dimensions: inadequate self-efficacy perception and stress/discomfort perception. Higher scores indicate higher levels of perceived stress. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.90, with the sub-dimensions scoring 0.86 and 0.83, respectively (Cohen et al., 1983; Eskin et al., 2013). In this study, the Cronbach's alpha internal consistency coefficient was found to be 0.75 for the overall scale and 0.73 and 0.75 for the sub-dimensions, respectively.
Measured: Three months
The family empowerment scale scores
The Family Empowerment Scale, developed by Singh et al. (1995) and adapted into Turkish by Karakul et al. (2018), consists of 34 questions and three sub-dimensions, rated on a four-point Likert scale. Higher scores indicate stronger family empowerment. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.89. The sub-dimensions had the following Cronbach's alpha values: 0.79 for the Family subdimension, 0.83 for the Service system subdimension, and 0.79 for the Community/Political sub-dimension (Karakul et al., 2018; Singh et al., 1995). In this study, Cronbach's alpha coefficient was 0.79 for the overall scale, 0,83 for the family dimension, 0,89 for the services sub-dimension and 0,85 the community/political sub-dimension.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Sep 2020
- Primary completion30 Sep 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- This unblinded, randomized controlled interventional study with two parallel groups involved parents of children diagnosed with autism. Participants were stratified according to their educational status, and each participant was assigned a number. Participants within each stratum were assigned to either the intervention or control groups using simple randomization with a table of random numbers.The study was completed with a total of 69 participants: 34 in the intervention group and 35 in the control group.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damla Şahin Büyük, Phd, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629974
- Sponsor's protocol ID
- MCBU-SBF-RK-01
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data may be shared with individual researchers upon request after the study has been completed and published; however, for data security reasons, sharing the data prior to publication is not being considered.
Publications
Karakul, A., Akgül, E. A., Doğan, P., Sarı, H. Y., 2018. Psychometric properties of the family empowerment scale in Turkish. Izmir Katip Celebi Univ. J. Health Sci. 3(3) 111.
Singh, N. N., Curtis, W. J., Ellis, C. R., Nicholson, M. W., Villani, T. M., Wechsler, H. A., 1995. Psychometric analysis of the family empowerment scale. J. Emotion. Behav. Disord. 3, 85-91.
Eskin, M., Harlak, H., Demirkıran, F., Dereboy, Ç., 2013. Adaptation of the perceived stress scale into Turkish: reliability and validity analysis. New Symp. J. 51, 132-140.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Inci, F., Erdem, M., 2006. Adaptation of the Caregiving Burden Scale into Turkish, its validity and reliability. Anatol. J. Nurs. Health Sci. 11, 85-95.
Guimond, A., Moore, H., Aier, D., Maxon, E., Diken, I., 2005. Parental self-efficacy instrument for children with disabilities (PSICD): Short version. Unpublished scale. Arizona: Arizona State University.
Diken, I. H., 2007.Turkish mothers' self-efficacy beliefs and styles of interactions with their children with language delays. Early Child Dev. Care 179, 425-436.
Cavkaytar, A., Aksoy, V., & Ardıç, A., 2014. Updating the validity and reliability study of the parent self-efficacy scale. Anadolu J. Educ. Sci. Int. 4, 69-76.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
PubMed 7203086Sahin Buyuk D, Ozmen D. Effectiveness of a Parent Empowerment Program for Parents of Children with Autism: A Randomized Controlled Trial. Child Care Health Dev. 2025 Sep;51(5):e70148. doi: 10.1111/cch.70148.
PubMed 40751565
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Empowerment Program for Parents of Children With Autism: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06629974
- Acronym / sponsor ID
- MCBU-SBF-RK-01
- Conditions
- Autism, Parenting, Motivational Interviewing
- Keywords
- Autism, Parent training, Empowerment, Parental self-efficacy, Parental stress, Care burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 8 Oct 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.
This study aims to evaluate the effectiveness of an empowerment program that includes both parent training and motivational interviewing for parents of children with autism, supporting their competence in the care of their children.
Detailed description
This study was conducted to evaluate the effectiveness of an empowerment program for parents of children with autism to support their competence in caring for their children. This randomized controlled study was conducted in Manisa city center/Turkey, in 2022. A total of 69 parents (intervention: 34, control: 35) were included in this unblinded, two-group randomized controlled interventional study. A parent empowerment program, including four parental training sessions and two motivational interview sessions, were applied to the parents in the intervention group. The Parental Self-Efficacy Scale, Zarit Care Burden Scale, Perceived Stress Scale, and Family Empowerment Scale were used to evaluate the effectiveness of the empowerment program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This unblinded, randomized controlled interventional study with two parallel groups involved parents of children diagnosed with autism. Participants were stratified according to their educational status, and each participant was assigned a number. Participants within each stratum were assigned to either the intervention or control groups using simple randomization with a table of random numbers.The study was completed with a total of 69 participants: 34 in the intervention group and 35 in the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Parental empowerment programParticipants in this group were administered the pre-intervention introductory information form, The Parental Self-Efficacy Scale, the Zarit Care Burden Scale, the Perceived Stress Scale and the Family Empowerment Scale. Then, a group empowerment training program consisting of four sessions in total was applied to the participants. Two motivational interview sessions were conducted with each participant in the intervention group 10 days after the empowerment training program. One month after the motivational interview sessions were completed, post-test data were collected. |
| Control group | No intervention | –No intervention was applied to the control group. The data collection tools applied to the intervention group in the pre-test and post-test were also applied to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were having a child diagnosed with ASD between the ages of 6 and 14, being literate, and volunteering to participate in the study.
Key exclusion criteria (1 listed)
- Having a child with a concomitant disability or disease (e.g., epilepsy, attention deficit, and hyperactivity disorder, other physical or mental disabilities), previous participation in an education program with similar content, or parents who did not participate in at least two-thirds of the empowerment training program or did not attend all motivational interview sessions were excluded from the study, and their data were not included in the analysis.
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 |
|---|---|---|
| Parental empowerment programThe empowerment program consisted of two parts: the empowerment training program for parents and motivational interviews. The empowerment training program was prepared to enable parents to carry out the care process more effectively in areas where parents have difficulties caring for their children with autism. Within the scope of the empowerment training program, parents were trained on the importance of play and communication, problems and management in the field of nutrition, sleep problems and management, safety and protection from accidents, and problems and management in the field of self-care. Ten days after the empowerment training program, two face-to-face motivational interviews were conducted with each participant in the intervention group. Each participant had a one-week break between the first and second motivational interviews. Each motivational interview session lasted approximately 25-30 minutes. | Behavioural | Intervention group |
Primary outcome
The parental self-efficacy scale scores
Time frame: Three months
The scale was developed by Guimond et al. (2005) to measure the self-efficacy of parents of children with disabilities regarding parenting skills (Guimond et al., 2005). The Turkish adaptation of the scale was first made by Diken (2007) and then by Cavkaytar et al. (2014) (Cavkaytar et al., 2014; Diken, 2007). The Parental Self-Efficacy Scale is a seven-point Likert-type rating scale consisting of 17 items. The lowest and highest values that can be taken from the scale are 17 and 119. Higher scores indicate higher self-efficacy perceptions. The Cronbach Alpha internal consistency coefficient value of the scale was calculated as 0.95 (Cavkaytar et al., 2014). The Cronbach's Alpha internal consistency coefficient value of the scale in this study is 0.96.
The zarit care burden scale scores
Time frame: Three months
The Zarit Care Burden Scale was developed by Zarit et al. in 1980 and adapted to Turkish by Inci and Erdem (2006). The scale is a 22-item, five-point Likert-type scale used to evaluate the stress experienced by caregivers of individuals in need of care. A minimum score of 0 and a maximum score of 88 can be obtained from the scale. The higher the score obtained from the scale, the higher the care burden felt. The Cronbach's Alpha internal consistency coefficient value of the scale was found to be 0.75 in the original study (Inci and Erdem, 2006; Zarit et al., 1980) and 0.89 in this study.
The perceived stress scale scores
Time frame: Three months
The Perceived Stress Scale was developed by Cohen et al. (1983) and adapted into Turkish by Eskin et al. This 14-item, five-point Likert-type scale has two sub-dimensions: inadequate self-efficacy perception and stress/discomfort perception. Higher scores indicate higher levels of perceived stress. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.90, with the sub-dimensions scoring 0.86 and 0.83, respectively (Cohen et al., 1983; Eskin et al., 2013). In this study, the Cronbach's alpha internal consistency coefficient was found to be 0.75 for the overall scale and 0.73 and 0.75 for the sub-dimensions, respectively.
The family empowerment scale scores
Time frame: Three months
The Family Empowerment Scale, developed by Singh et al. (1995) and adapted into Turkish by Karakul et al. (2018), consists of 34 questions and three sub-dimensions, rated on a four-point Likert scale. Higher scores indicate stronger family empowerment. The Cronbach's alpha internal consistency coefficient for the entire scale was 0.89. The sub-dimensions had the following Cronbach's alpha values: 0.79 for the Family subdimension, 0.83 for the Service system subdimension, and 0.79 for the Community/Political sub-dimension (Karakul et al., 2018; Singh et al., 1995). In this study, Cronbach's alpha coefficient was 0.79 for the overall scale, 0,83 for the family dimension, 0,89 for the services sub-dimension and 0,85 the community/political sub-dimension.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- BackgroundKarakul, A., Akgül, E. A., Doğan, P., Sarı, H. Y., 2018. Psychometric properties of the family empowerment scale in Turkish. Izmir Katip Celebi Univ. J. Health Sci. 3(3) 111.
- BackgroundSingh, N. N., Curtis, W. J., Ellis, C. R., Nicholson, M. W., Villani, T. M., Wechsler, H. A., 1995. Psychometric analysis of the family empowerment scale. J. Emotion. Behav. Disord. 3, 85-91.
- BackgroundEskin, M., Harlak, H., Demirkıran, F., Dereboy, Ç., 2013. Adaptation of the perceived stress scale into Turkish: reliability and validity analysis. New Symp. J. 51, 132-140.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundInci, F., Erdem, M., 2006. Adaptation of the Caregiving Burden Scale into Turkish, its validity and reliability. Anatol. J. Nurs. Health Sci. 11, 85-95.
- BackgroundGuimond, A., Moore, H., Aier, D., Maxon, E., Diken, I., 2005. Parental self-efficacy instrument for children with disabilities (PSICD): Short version. Unpublished scale. Arizona: Arizona State University.
- BackgroundDiken, I. H., 2007.Turkish mothers' self-efficacy beliefs and styles of interactions with their children with language delays. Early Child Dev. Care 179, 425-436.
- BackgroundCavkaytar, A., Aksoy, V., & Ardıç, A., 2014. Updating the validity and reliability study of the parent self-efficacy scale. Anadolu J. Educ. Sci. Int. 4, 69-76.
- Results publication: PubMed 7203086Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Derived from this study: PubMed 40751565Sahin Buyuk D, Ozmen D. Effectiveness of a Parent Empowerment Program for Parents of Children with Autism: A Randomized Controlled Trial. Child Care Health Dev. 2025 Sep;51(5):e70148. doi: 10.1111/cch.70148.
- Individual participant dataSharing planned: No. The data may be shared with individual researchers upon request after the study has been completed and published; however, for data security reasons, sharing the data prior to publication is not being considered.
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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. This study is not recruiting at the moment.
Damla Şahin Büyük, Phd principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental empowerment program in people with Autism and Parenting, run by Manisa Celal Bayar 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 1 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 8 Oct 2024. 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 parental self-efficacy scale scores (time frame: Three months). 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?
On the ClinicalTrials.gov record for NCT06629974, which also lists 10 linked publications.
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 8 Oct 2024.