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Effects of Animation Therapy on Children With ADHD

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Animation Therapy
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention, Hyperactivity, Animation, Occupational Therapy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Animation Therapy Group

Control Group

Arm Description

10 sessions of Animation Therapy (1 session/week)

No intervention

Outcomes

Primary Outcome Measures

Conners Parents Rating Scale-Revised Long Form
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.
Conners Parents Rating Scale-Revised Long Form
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.
Conners Teachers Rating Scale-Revised Long
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.
Conners Teachers Rating Scale-Revised Long
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.
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
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.
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
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.
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
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.
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
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.

Secondary Outcome Measures

Full Information

First Posted
February 15, 2022
Last Updated
June 6, 2023
Sponsor
Kutahya Health Sciences University
Collaborators
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05274282
Brief Title
Effects of Animation Therapy on Children With ADHD
Official Title
Use of Animation in Therapy: Effects on Symptom Levels of Children With Attention Deficit and Hyperactivity Disorder, a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
Collaborators
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention, Hyperactivity, Animation, Occupational Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Animation Therapy Group
Arm Type
Experimental
Arm Description
10 sessions of Animation Therapy (1 session/week)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Animation Therapy
Intervention Description
Stop-motion movie shooting process designed for improving attention skill and regulating hyperactive and impulsive behaviours.
Primary Outcome Measure Information:
Title
Conners Parents Rating Scale-Revised Long Form
Description
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.
Time Frame
Baseline, pre-intervention
Title
Conners Parents Rating Scale-Revised Long Form
Description
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.
Time Frame
Immediately after the intervention
Title
Conners Teachers Rating Scale-Revised Long
Description
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.
Time Frame
Baseline, pre-intervention
Title
Conners Teachers Rating Scale-Revised Long
Description
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.
Time Frame
Immediately after the intervention
Title
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
Description
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.
Time Frame
Baseline, pre-intervention
Title
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - Home Rating Scale
Description
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.
Time Frame
Immediately after the intervention
Title
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
Description
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.
Time Frame
Baseline, pre-intervention
Title
the Scales for Diagnosing Attention-Deficit/Hyperactivity Disorder - School Rating Scale
Description
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.
Time Frame
Immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Özgün Belen, MSc
Organizational Affiliation
Kutahya Health Sciences University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burcu Semin Akel, Professor
Organizational Affiliation
İstanbul Kültür University
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Animation Therapy on Children With ADHD

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