NCT07027319

Brief Summary

This project will be conducted in a private autism center in order to investigate the effects of Triple P training, which will be given to parents of children with Autism Spectrum Disorder, on the children's repetitive behaviors and the parents' burnout levels. The study is a randomized controlled trial and the study sample will consist of parents of children with Autism Spectrum Disorder. The children/parents included in the study sample will be numbered according to the order of arrival and 35 will be assigned to the intervention group and 35 will be assigned to the control group. During the randomization phase of the study, 70 children/parents with ASD will be randomly assigned to the intervention and control groups using Statistical Analysis Software. Data analysis will be performed using the Statistical Package for Social Sciences (SPSS v26.0, IBM Corp., Armonk, NY, USA). Descriptive data will be analyzed as mean, frequency and percentage. The conformity of quantitative data to normal distribution will be evaluated using the Kolmogorov-Smirnov test. Paired sample t-test will be used to compare dependent groups with normal distribution, independent sample t-test will be used to compare independent groups with normal distribution. P value will be considered significant if it is less than 0.05.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

April 22, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

May 1, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

Autismpositive parenting programparent educationpsychiatric nursing

Outcome Measures

Primary Outcomes (1)

  • General mental state of parents of children with autism spectrum disorder

    General Health Questionnaire-28-Will be used to evaluate the general mental state of parents of children with autism spectrum disorder. The scale, developed by Goldberg and utilizing the "GSA-type scoring" method, is used as a four-item scale in which the first two items are scored negatively and the last two items positively. Accordingly, items a and b are scored as "0" (zero), while items c and d are scored as "1" (one). The total score on the scale can range from a minimum of 0 to a maximum of 28. Individuals who score 4 or below are considered to be "normal" in terms of mental health, whereas those who score 5 or above are evaluated as being in the "at-risk group" regarding their mental health.

    T1: Baseline T2: 8 weeks T3: 3 months post-intervention

Other Outcomes (2)

  • Assessment of repetitive behaviors in children with autism spectrum disorders

    T1: Baseline T2: 8 weeks T3: 3 months post-intervention

  • Burnout levels of parents of children with autism spectrum disorder

    T1: Baseline T2: 8 weeks T3: 3 months post-intervention

Study Arms (2)

Control group

NO INTERVENTION

This group will not be given any training other than the training they receive from the institution.

Parenting Education

EXPERIMENTAL

The intervention group will receive 8 sessions of Triple P (positive parenting training).

Other: Parenting Education

Interventions

The intervention group will receive 8 sessions of Triple P (positive parenting training).

Also known as: Triple P (Positive Parenting Program)
Parenting Education

Eligibility Criteria

Age0 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Having a child diagnosed with Autism Spectrum Disorder between the ages of 0 and 12
  • Being willing to participate in the study
  • Parents who speak Turkish

You may not qualify if:

  • Parents of children with Autism Spectrum Disorder who are 13 years of age or older
  • Parents who do not speak Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University

Istanbul, Üsküdar, 34662, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Elçin Babaoğlu, Asst. Prof. Dr.

    Uskudar University

    STUDY DIRECTOR

Central Study Contacts

Elçin Babaoğlu, Asst. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

May 1, 2025

First Posted

June 18, 2025

Study Start

April 22, 2025

Primary Completion

July 31, 2025

Study Completion

October 31, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

It is planned to share the pre-test, post-test and 3-month follow-up results obtained in the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
It is planned to be opened for access on 15.10.2025.
Access Criteria
It will be shared with researchers who contact the researcher.

Locations