NCT06624527

Brief Summary

The aim of this study was planned to determine the changes that cognitive behavior therapy-based psycho-education against the negativities brought by the disease in the long term of children diagnosed with Attention Deficit Hyperactivity Disorder will create changes in the child's quality of life, anxiety and depression status and disease symptoms. As a result of this study, if cognitive behavior-based psycho-education has a positive effect on anxiety, depression and quality of life of children with Attention Deficit Hyperactivity Disorder, it is thought to contribute positively to the development of the disease for the sick child and parents by organizing psycho-education programs with the training to be given to child health nurses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

September 26, 2024

Last Update Submit

March 11, 2025

Conditions

Keywords

Child,Attention deficit Hyperactivity disorderCognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Psycho-educational application based on Cognitive Behavioral Therapy

    This study will investigate how cognitive behavior-based psychoeducation given to children diagnosed with Attention Deficit Hyperactivity Disorder will affect the child's quality of life, anxiety, and depression. Two scales will be used to measure the results of the interventions made in the research. These scales are: 1-Child Anxiety and Depression Scale; consists of 47 items. 2.Quality of life scale for children consists of 23 items.

    4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

No intervention will be made to the control group. This group will be given a first test using the scales specified in the data collection, and a final test will be given 30 days later using the same scales.

Intervention group

EXPERIMENTAL

After the first test application with the scales specified in the data collection, 8 sessions of Cognitive Behavior Therapy-based psycho-education sessions will be applied to the intervention group. At the end of the 8 sessions (which will last 30 days on average), a final test will be applied.

Other: Psychoeducation based on Cognitive Behavioral Therapy

Interventions

A psycho-educational application based on Cognitive Behavior Therapy consisting of a total of 8 sessions prepared by the researcher.

Intervention group

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children who are diagnosed with ADHD according to DSM-V diagnostic criteria,
  • Do not have another psychiatric disorder not specific to ADHD,
  • Do not have a mental disability,
  • Do not seek pharmacological treatment,
  • Are between the ages of 8-16,
  • Can read and write,
  • Can communicate and cooperate,
  • Agree to participate in the study (parents and/or themselves) are included in the study.

You may not qualify if:

  • Those with another psychiatric disorder not specific to ADHD,
  • Those with mental retardation,
  • Those receiving pharmacological treatment,
  • Those between the ages of 8-16,
  • Those who cannot read or write,
  • Those who request to withdraw from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital

Kahramanmaraş, OnikiŞubat, 46500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • vedat Argın, lecturer

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In this study, the sample group was determined in the masking process. The sample group was divided into a control group and an intervention group using a random sampling method. It was not disclosed which group the participants were in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was planned as a pre-test/post-test, single blind randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 3, 2024

Study Start

September 25, 2023

Primary Completion

December 15, 2024

Study Completion

January 3, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations