Investigating the Effects of the Temporal Adaptation Approach in Children With ADHD

NCT06770725 | Completed

• 1 other identifier: 61351342 / ARALIK 2023-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the impact of temporal adaptation interventions on children with Attention Deficit Hyperactivity Disorder (ADHD), focusing on activity self-efficacy, time perception, daily activity routines, and executive functions. The intervention aims to address the challenges ADHD children face in time processing abilities, which include understanding the concept of time, being punctual, initiating and completing daily activities independently, planning and completing long-term projects, using a calendar, and hurrying when necessary. The research will be conducted at the Hacettepe University Faculty of Health Sciences Department of Occupational Therapy's educational and research units. Participants will be children diagnosed with ADHD by a Child and Adolescent Psychiatrist. These children will then be randomly assigned to control and training groups. A total of 60 individuals, 30 for each group, will be included in the study based on power analysis. The effectiveness of the study will be shared, and should it prove effective, the same study will be replicated with the control group. The intervention consists of activities designed to enhance temporal adaptation, adapted for ADHD from models in the literature. Over 10 weeks, the children will engage in weekly 60-minute sessions, each week focusing on different activities to improve temporal adaptation skills. Activities include teaching concepts of calendars and clocks, rhythm exercises with metronomes, time estimation games, daily and weekly planner preparation, time matching games, and exercises to improve time management and planning abilities. Data will be collected using various tools including a demographic information form, time perception threshold measurement tasks, temporal production tasks, Child Activity Self-Assessment Scale (COSA), and Executive Functions and Occupational Routines Scale (EFORTS). The study's hypotheses test the null hypothesis that temporal adaptation intervention does not affect activity self-efficacy, time perception, daily activity routine, and executive functions in children aged 9-12 with ADHD. This comprehensive approach aims to enhance the daily lives of children with ADHD by improving their ability to manage time effectively, thereby positively affecting their education, self-care, social relationships, and overall quality of life.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Temporal Adaptation; Time Management; Time Perception; Occupational self-efficacy; Executive Functions

Outcome Measures

Primary Outcomes (4)

• Time Perception Threshold Measurement

  Assesses the ability to discriminate between different durations.

  From enrollment to the end of treatment at 10 weeks

• Temporal Production Task

  Evaluates the accuracy of reproducing time intervals.

  From enrollment to the end of treatment at 10 weeks

• Child Occupational Self-Assessment Scale

  The Child Occupational Self-Assessment Scale measures perceived efficacy and importance in daily activities. The scale consists of 25 items that evaluate the children's perceived occupational performance and the importance of the occupations under seven areas. All questions are scored from 1 to 4. The scale yields 14 different sub-scores (a performance and an importance score for each area). The Communication and the Executive Functions sub-scores range between 6 and 24, the Motor Skills sub-scores range between 3 and 12, the Academic sub-scores range between 5 and 20 and the Self Regulation, Intrumental Activities of Daily Living and Activities of Daily Living sub-scores range between 2 and 8. For the performance sub-scores, a higher score indicate better perceived performance. For the importance sub-scores, a higher score indicate higher given importance.

  From enrollment to the end of treatment at 10 weeks

• Executive Functions and Occupational Routines Scale

  The scale ssesses executive functioning and daily routines. The scale consists of 30 items, divided into subscales based on everyday functional routines, scored from 1 (never) to 5 (always). The scale does not have a total score, rather, a mean score is calculated for each sub-scale as well as the total scale. The mean score ranges between 1 and 5, with with higher scores indicating better executive control.

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

The participants who are allocated to the Control Group arm will receive conventional occupational therapy interventions for the duration of the study.

Behavioral: Conventional Occupational Therapy

Experimental Group

EXPERIMENTAL

Participants allocated to the Experimental Group will receive Temporal Adaptation Intervention during the study.

Behavioral: Temporal Adaptation Intervention

Interventions

Temporal Adaptation Intervention BEHAVIORAL

The research on temporal adaptation intervention will be conducted through activities and individual sessions within the framework of temporal adaptation intervention. The activities included in the temporal adaptation intervention used in our research have been adapted for ADHD by referencing temporal adaptation training models in the literature.

Experimental Group

Conventional Occupational Therapy BEHAVIORAL

The control group will be given a 10-week-long conventional occupational therapy intervention by the investigator (Fatma Temizkan). The intervention will consist of occupational therapy approaches such as; obstacle courses, sensory integration, motor skills training, cognitive skills training, sequenced activities and so on.

Control Group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must be between 9 and 12 years of age.
• Clinical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
• Must be willing to participate and adhere to the study protocols

You may not qualify if:

• \* Additional psychiatric or developmental diagnoses that can interfere with the study outcomes

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Çankaya, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gonca Bumin, PhD.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: February 3, 2021
• Primary Completion: October 10, 2024
• Study Completion: January 31, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)