NCT05407688

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

June 2, 2022

Last Update Submit

May 31, 2023

Conditions

Keywords

attention deficit hyperactivity disorderadolescentparticipationPEM-CY

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of ADHD symptoms

    Baseline

Study Arms (2)

ADHD group

Adolescents with ADHD

Health group

Adolescents without ADHD

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Adolescents with ADHD at 12-17 years old and their parents. Healthy adolescents at aged 7-12 years old and their parents.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • 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 2020 Jun 20.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

September 1, 2022

Primary Completion

April 15, 2023

Study Completion

May 29, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations