- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05274282
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
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
48
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
No intervention
|
|
|
Experimental: Animation Therapy Group
10 sessions of Animation Therapy (1 session/week)
|
Stop-motion movie shooting process designed for improving attention skill and regulating hyperactive and impulsive behaviours.
|
What is the study measuring?
Primary Outcome Measures
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.
Collaborators
Investigators
- Principal Investigator: Özgün Belen, MSc, Kütahya 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)
May 15, 2023
Primary Completion (Actual)
February 9, 2024
Study Completion (Actual)
February 9, 2024
Study Registration Dates
First Submitted
February 15, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 10, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 2, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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