- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06629974
The Effects of an Empowerment Program for Parents of Children With Autism
The Effects of an Empowerment Program for Parents of Children With Autism: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Manisa, Turkey, 45000
- Manisa Celal Bayar University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
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.
|
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. |
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Three months
|
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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.
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Three months
|
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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.
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Three months
|
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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.
|
Three months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Damla Şahin Büyük, Phd, Manisa Celal Bayar University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Inci, 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU-SBF-RK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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