Attention Deficit Hyperactivity DisorderNCT05407688
Compatibility of Participation Levels of Adolescents With Attention Deficit and Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 29 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents with ADHD at 12-17 years old and their parents. Healthy adolescents at aged 7-12 years old and their parents.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compatibility of Participation Levels of Adolescents With Attention Deficit and Hyperactivity Disorder in Terms of Adolescent and Parent Perspectives
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.
Read the detailed 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, adolescent, participation, PEM-CY
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Adolescents with ADHD | |
| Health group | Adolescents without ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Sep 2022
- Primary completion15 Apr 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgun Kaya Kara, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407688
- Sponsor's protocol ID
- 2021/339
- Status last verified
- May 2023
- First submitted
- 2 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16784495Dada 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.
PubMed 32574934Kaya 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.
PubMed 32776565Shimoni 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.
PubMed 20705424
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compatibility of Participation Levels of Adolescents With Attention Deficit and Hyperactivity Disorder in Terms of Adolescent and Parent Perspectives
- ClinicalTrials.gov ID
- NCT05407688
- Acronym / sponsor ID
- 2021/339
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, adolescent, participation, PEM-CY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Adolescents with ADHD |
| Health group | – | –Adolescents without ADHD |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents with ADHD at 12-17 years old and their parents. Healthy adolescents at aged 7-12 years old and their parents.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of participation
Time frame: baseline
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).
1 secondary outcome
Evaluation of ADHD symptoms
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Results publication: PubMed 16784495Klassen 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.
- Results publication: PubMed 32574934Dada 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.
- Results publication: PubMed 32776565Kaya 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.
- Results publication: PubMed 20705424Shimoni 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.
- Diagnostic and statistical manual of mental disorders (DSM-5®)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of participation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407688, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.