NCT05274282

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 15, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2024

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

February 15, 2022

Last Update Submit

March 2, 2025

Conditions

Keywords

AttentionHyperactivityAnimationOccupational Therapy

Outcome Measures

Primary Outcomes (8)

  • 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.

    Baseline, pre-intervention

  • 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.

    Immediately after the intervention

  • 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.

    Baseline, pre-intervention

  • 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.

    Immediately after the intervention

  • 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.

    Baseline, pre-intervention

  • 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.

    Immediately after the intervention

  • 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.

    Baseline, pre-intervention

  • 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.

    Immediately after the intervention

Study Arms (2)

Animation Therapy Group

EXPERIMENTAL

10 sessions of Animation Therapy (1 session/week)

Other: Animation Therapy

Control Group

NO INTERVENTION

No intervention

Interventions

Stop-motion movie shooting process designed for improving attention skill and regulating hyperactive and impulsive behaviours.

Animation Therapy Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasm

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Özgün Belen, MSc

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR
  • Burcu Semin Akel, Professor

    İstanbul Kültür University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2022

First Posted

March 10, 2022

Study Start

May 15, 2023

Primary Completion

February 9, 2024

Study Completion

February 9, 2024

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations