Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Compatibility of Participation Levels of Adolescents With Attention Deficit and Hyperactivity Disorder in Terms of Adolescent and Parent Perspectives
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 |
Verified date | May 2023 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
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
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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