Effects of Animation Therapy on Children With ADHD

March 2, 2025 updated by: Ozgun Belen, Kutahya Health Sciences University

Use of Animation in Therapy: Effects on Symptom Levels of Children With Attention Deficit and Hyperactivity Disorder, a Randomized Trial

The aim of the study is to determine the effects of animation therapy on the main symptoms of Attention Deficit - Hyperactivity Disorder; hyperactivity, inattention and impulsivity.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

Attention Deficit and Hyperactivity Disorder (ADHD) is the most frequent childhood disorder, that is characterized with three main symptoms: inattention, hyperactivity, and impulsivity. Animation Therapy is the use of a stop-motion movie production process for therapeutic purposes. This new approach may have promising effect on attention because of its flow effect. Also, there is only one study on the effectiveness of Animation Therapy in literature. This study is planned to investigate the effects of Animation Therapy on the main symptoms of the disorder.

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.
48

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
      • Ankara, Turkey
        • Hacettepe University

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

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being at the age between 6-12 years.
  • Being diagnosed with ADHD by a psychiatrist.
  • Taking prescribed medication for treatment of ADHD.
  • Having no physical, visual or mental problems.

Exclusion Criteria:

  • Absence in pre- and post-intervention evaluations
  • Not completing 10-weeks of re-animation approach intervention process.
  • Discontinuation of medical treatment for ADHD.

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.
No Intervention: Control Group
No intervention
Experimental: Animation Therapy Group
10 sessions of Animation Therapy (1 session/week)
Other: Animation Therapy
Stop-motion movie shooting process designed for improving attention skill and regulating hyperactive and impulsive behaviours.

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
Conners Parents Rating Scale-Revised Long Form
Time Frame: Baseline, pre-intervention
Conners Parents Rating Scale-Revised Long Form is a 4-points-Likert-scale, consisting of 80 items. The given items are expressions defining the daily life behaviors of children at home setting due to ADHD. Parents mark a score between 0 (means "expression never suits my child's behavior) and 3 (means expression suits my child's behavior completely). It comprises of 14 behavioral categories: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious/Shy, Perfectionism, Social Problems, Psychosomatic, ADHD Index, Restless/Impulsive, Emotional Lability, Global Index, DSM-IV Inattention, DSM-IV Hyperactive/Impulsive, and DSM-IV Total. A higher score indicates more severe symptoms.
Baseline, pre-intervention
Conners Parents Rating Scale-Revised Long Form
Time Frame: Immediately after the intervention
Conners Parents Rating Scale-Revised Long Form is a 4-points-Likert-scale, consisting of 80 items. The given items are expressions defining the daily life behaviors of children at home setting due to ADHD. Parents mark a score between 0 (means "expression never suits my child's behavior) and 3 (means expression suits my child's behavior completely). It comprises of 14 behavioral categories: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious/Shy, Perfectionism, Social Problems, Psychosomatic, ADHD Index, Restless/Impulsive, Emotional Lability, Global Index, DSM-IV Inattention, DSM-IV Hyperactive/Impulsive, and DSM-IV Total. A higher score indicates more severe symptoms.
Immediately after the intervention
Conners Teachers Rating Scale-Revised Long
Time Frame: Baseline, pre-intervention
Conners Teachers Rating Scale-Revised Long is a 4-points-Likert-scale, consisting of 59 items. The items define the school life behaviors of children due to ADHD. The child's teacher marks a score from 0 (means "expression never suits child's behavior) to 3 (means expression suits child's behavior completely). It comprises 14 behavioral categories: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious/Shy, Perfectionism, Social Problems, ADHD Index - Inattention, ADHD Index - Hyperactivity, Restless/Impulsive, Emotional Lability, Global Index, DSM-IV Inattention, DSM-IV Hyperactive/Impulsive, and DSM-IV Total. A higher score indicates more severe symptoms.
Baseline, pre-intervention
Conners Teachers Rating Scale-Revised Long
Time Frame: Immediately after the intervention
Conners Teachers Rating Scale-Revised Long is a 4-points-Likert-scale, consisting of 59 items. The items define the school life behaviors of children due to ADHD. The child's teacher marks a score from 0 (means "expression never suits child's behavior) to 3 (means expression suits child's behavior completely). It comprises 14 behavioral categories: Oppositional, Cognitive Problems/Inattention, Hyperactivity, Anxious/Shy, Perfectionism, Social Problems, ADHD Index - Inattention, ADHD Index - Hyperactivity, Restless/Impulsive, Emotional Lability, Global Index, DSM-IV Inattention, DSM-IV Hyperactive/Impulsive, and DSM-IV Total. A higher score indicates more severe symptoms.
Immediately after the intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
Time Frame: Baseline, pre-intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale measures the levels of hyperactivity, impulsivity, and inattention from the parent's perspective. It is a 4-points-Likert-scale, consisting of 40 items. Each item describes a specific behavior correlated with ADHD and parents scores items due to the frequency of behavior described by the item, considering the behaviors of the child at home setting. A high score means high frequency and more severe symptoms.
Baseline, pre-intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
Time Frame: Immediately after the intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale measures the levels of hyperactivity, impulsivity, and inattention from the parent's perspective. It is a 4-points-Likert-scale, consisting of 40 items. Each item describes a specific behavior correlated with ADHD and parents scores items due to the frequency of behavior described by the item, considering the behaviors of the child at home setting. A high score means high frequency and more severe symptoms.
Immediately after the intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
Time Frame: Baseline, pre-intervention
A scale that measures the levels of hyperactivity, impulsivity, and inattention from the teachers' perspective. It is a 4-points-Likert-scale, consisting of 39 items. Each item describes a specific behavior correlated with ADHD and parents scores items due to the frequency of behavior described by the item, considering the behaviors of the child at home setting. A high score means high frequency and more severe symptoms.
Baseline, pre-intervention
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
Time Frame: Immediately after the intervention
A scale that measures the levels of hyperactivity, impulsivity and inattention on the perspective of the teachers. It is a 4-points-Likert-scale, consisting of 39 items. Each item describes a specific behavior correlated with ADHD and parents scores items due to frequency of behavior described by the item, considering the behaviors of the child at home setting. High score means high frequency and more severe symptom.
Immediately after 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.
Kutahya Health Sciences University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Özgün Belen, MSc, Kutahya Health Sciences University
  • Study Director: Burcu Semin Akel, Professor, Istanbul Kultur 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.
May 15, 2023

Primary Completion (Actual)

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.
February 9, 2024

Study Completion (Actual)

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.
February 9, 2024

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).
February 15, 2022

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.
March 1, 2022

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.
March 10, 2022

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.
March 25, 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.
March 2, 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.
March 1, 2025

More Information

Terms related to this study

Keywords

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.
  • GO 15/728-22

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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