NCT06629974

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 4, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

AutismParent trainingEmpowermentParental self-efficacyParental stressCare burden

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Three months

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, 45000, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 6668417BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

  • Sahin 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.

MeSH Terms

Conditions

Autistic DisorderEmpowermentCaregiver Burden

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehaviorStress, PsychologicalBehavioral Symptoms

Study Officials

  • Damla Şahin Büyük, Phd

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

September 30, 2020

Primary Completion

September 30, 2022

Study Completion

December 23, 2022

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations