Cognitive-Based Behavior Change Training Program

May 14, 2025 updated by: SELMA HASANOĞLU, Uskudar University

The Effect of the 'Cognitive-Based Behavior Change Training Program' Applied to Parents of Preschool Children With Behavior Problems on Parents' Attitudes and Stress Levels Towards the Child and on the Problematic Behaviors of the Children

This study will be conducted to determine the effects of the Parent Education Program Based on the Cognitive Development of the Child, which is applied to the parents of preschool children with behavioral problems, on the attitudes and stress levels of the parents and the problematic behaviors of the children.

The purpose of this study has two dimensions;

Dimension 1: The 'Parent Education Program Based on the Cognitive Development of the Child', which is planned to be developed for the purpose of measuring the attitudes, stress levels of the parents and the effects on the problematic behaviors of the children.

The development of the program was based on Jean Piaget's theory of cognitive development.

Dimension: It is experimental. The aim is to reveal the effectiveness of the Parent Education Program, which will be applied to the parents of children with behavioral problems. There are parent training programs developed for children with behavioral problems in the preschool period. However, the lack of parent studies based on the child's cognitive development reveals the rationale and importance of this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gazi̇antep, Turkey
        • Gaziantep Municipality Kindergartens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children must be between the ages of 3-6
  • Participating in the study as a mother and father together
  • Not having attended any parent training

Exclusion Criteria:

  • Participating in the study as a single parent
  • The child must have been diagnosed in the special needs category

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Implementation of the 8-session parent study
Behavioral: Cognitive-Based Behavior Change Training Program

Parents will be given an 8-session parent training program.

Session 1: Establishing a trusting relationship and informing them about the study Session 2: Informing parents about the cognitive development of 3-6 year old children Theme: Children learn with 'numbers/scales/amounts' Session 3: Parents being consistent in their approach to children Theme: Children learn with the all/or nothing rule Session 4: Reinforcing positive behaviors in children Theme: Children Learn Laterally Session 5: Parents being positive models Theme: Children Learn by Imitation Session 6: Guidance of parents on the principle of 'learning by doing and experiencing' Theme: Children Learn by Action Session 7: This is the last session. Session 8: Application of final tests and saying goodbye.
No Intervention: Control groups
Group where parental work was not implemented

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Preschool Behavior Problems Screening Scale
Time Frame: One month prior to the intervention / One month following the intervention
The "Preschool Behavior Questionnaire" developed by Behar (1976; Cited in Kanlıkılıçer, 2005) is a Likert-type scale used to determine the behavioral problems of preschool children. The scale was adapted to Turkish by Kanlıkılıçer, and the propositions in the scale were converted into questions and used. The original Turkish version of the "Preschool Behavior Problems Screening Scale" consists of 30 items. After the factor analysis conducted for this study, items with item loading values below .50 were removed, so 15 items were used. The highest score a child can get from the "Preschool Behavior Problems Screening Scale" is "30", and the lowest score is "0".
One month prior to the intervention / One month following the intervention
Parent Stress Scale
Time Frame: One month prior to the intervention / One month following the intervention
The "Parenting Stress Scale" was developed to measure the stress experienced by parents of children with normal developmental characteristics regarding parenting. The scale consists of 18 items and has a single-dimensional structure that includes the parent, parent-child relationship, and the characteristics of the child. The Parenting Stress Scale is a Likert-type measurement tool evaluated from 0 (Does not describe at all) to 4 (Describes very well). The range of scores that can be obtained from the scale is between 0-72, with higher scores indicating the level of parenting stress. The scale is a measurement tool that can be easily applied to parents with at least one child with a primary school education level or higher.
One month prior to the intervention / One month following the intervention
Parent Attitude Scale
Time Frame: One month prior to the intervention / One month following the intervention

The Parental Attitude Scale was developed by Evren Karabulut Demir to measure the attitudes of parents with children aged 2 to 6 years, and its validity and reliability study was conducted in collaboration with Gül Erdil. The scale is designed to be applied to parents of children within this age range and consists of 46 items grouped under four subdimensions: Democratic, Authoritarian, Overprotective, and Permissive. The scale is structured in a 5-point Likert format, with each item offering five response options that vary based on frequency or degree of agreement. Participants are asked to indicate their level of agreement with each statement using the following options:

1 = Strongly disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, and 5 = Strongly agree.

This Likert-type rating system allows for a quantitative evaluation of parental attitudes across the specified subdimensions. Some items are negatively worded and are therefore reverse-coded prior to analysis. Higher scores within ea
One month prior to the intervention / One month following the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uskudar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-97105791-050.04-51964

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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