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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05407688
Other study ID # 2021/339
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date May 29, 2023

Study information

Verified date May 2023
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to assess the agreement between the outcomes of adolescents with attention deficit hyperactivity disorder (ADHD) who participated in Participation and Environment Measurement Child & Youth (PEM-CY) by the adolescent and primary caregiver. There are a few studies in the literature that look at the participation of teenagers with ADHD, but none that look at the participation of adolescents with ADHD from both the perspective of the adolescents and the primary caregivers. The primary caregiver's measurement results and the adolescents' measurements do not concur, according to this study's hypothesis.


Description:

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in childhood. In addition to fundamental symptoms like inattention and hyperactivity/impulsivity, ADHD can be accompanied by a variety of diseases. Adolescents with ADHD are less likely to participate in activities at home, school, or in the community as a result of this. In comparison to children without ADHD, Shimoni et al. found that children with ADHD participate less frequently in most leisure activities, like formal leisure activities less, and have a lower desire for participation in specific leisure activities, such as physical and social leisure activities. Adolescents and their primary caregivers have disagreements on a variety of topics. This disagreement is also likely to arise when it comes to choose who will participate. Furthermore, while measuring the level of engagement, the need of gathering information from various sources is clear. The Participation and Environment Measurement-Children and Youth (PEM-CY) is a scale that evaluates parents' or caregivers' involvement with children and young people in the home, school, and community. Adolescents with ADHD had lower levels of participation in the home, school, and community than control groups, according to research. However, no study analyzing this level of bidirectional participation could be found in the existing literature (adolescent-primary caregivers). As a result, the primary goal of this study is to examine the participation of adolescents with ADHD from the perspectives of adolescents and primary caregivers using The Participation and Environment Measure for Children and Youth (PEM-CY), as well as to demonstrate the agreement between these two evaluations. Furthermore, it will be compared to healthy controls in terms of participation and agreement rates.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date May 29, 2023
Est. primary completion date April 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria: - Age between 7 years and 12 years; - Diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) by a child and adolescent health psychiatrist, regardless of subtype, according to DSM-V criteria - Have cognitive ability to follow instructions for assessment measures Exclusion Criteria: - Children have any other psychiatric diagnosis like autism spectrum disorder, psychotic symptoms, depression, etc. - Children have any neurological or orthopedic disorders like head injury, cerebral palsy, epileptic seizure, visual and speech disorder.

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Disease
  • Hyperkinesis

Locations

Country Name City State
Turkey Akdeniz University Antalya

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Dada S, Andersson AK, May A, Andersson EE, Granlund M, Huus K. Agreement between participation ratings of children with intellectual disabilities and their primary caregivers. Res Dev Disabil. 2020 Sep;104:103715. doi: 10.1016/j.ridd.2020.103715. Epub 202 — View Citation

Kaya Kara O, Turker D, Kara K, Yardimci-Lokmanoglu BN. Psychometric properties of the Turkish version of Participation and Environment Measure for Children and Youth. Child Care Health Dev. 2020 Nov;46(6):711-722. doi: 10.1111/cch.12801. Epub 2020 Aug 19. — View Citation

Klassen AF, Miller A, Fine S. Agreement between parent and child report of quality of life in children with attention-deficit/hyperactivity disorder. Child Care Health Dev. 2006 Jul;32(4):397-406. doi: 10.1111/j.1365-2214.2006.00609.x. — View Citation

Shimoni M, Engel-Yeger B, Tirosh E. Participation in leisure activities among boys with attention deficit hyperactivity disorder. Res Dev Disabil. 2010 Nov-Dec;31(6):1234-9. doi: 10.1016/j.ridd.2010.07.022. Epub 2010 Aug 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of participation Participation and Environment Measurement Child & Youth (PEM-CY) is a parent-report questionnaire to assess participation and environment factors in the home, at school, and within community settings. The participation sections included 10 activities in the home setting, five activities in the school setting and 10 in the community setting. For each activity, parents are asked to determine the participation frequency (how frequently has the child participates with eight options: daily to never), participation involvement (how involved the child is while participating in the activity rated on a five-point scale: very involved to minimally involved) and whether change is desired (do the parents want to see change in the child's participation in this type of activity: no or yes, with five different types of change). baseline
Secondary Evaluation of ADHD symptoms The Conners' Ratin Scale - Revised (CRS-R) was designed to address the need for a multimodal assessment of children and adolescents' behavioral difficulties and contains a parent form, a teacher form, and an adolescent self report form. The parent form, the CPRS-R, is appropriate for use with parents of children and adolescents ages 3 through 17. The Long Form contains 80 items and can be completed by most parents/guardians in approximately 20 minutes. Baseline
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