Attention Deficit Hyperactivity DisorderNCT05048043
Development of a Game-supported Intervention
A study testing Computer-assisted Behavior Intervention and Challenging Horizons Program in people with Attention Deficit Hyperactivity Disorder, run by East Carolina University at 2 sites in United States.
Trial summary
The investigators will develop and pilot test an innovative computer-assisted behavior intervention (CABI) for middle school students with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Computer-assisted Behavior Intervention and Challenging Horizons Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2021to 30 Jun 2022
- Phase
- Interventional
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All participants must meet DSM-5 criteria for ADHD (any presentation);
- A history of academic impairment (regardless of medication status)
Who cannot join
- Estimated full-scale IQ less than 80;
- Plans to leave the school district during the study timeframe;
- Psychiatric conditions ill-suited to the proposed intervention (e.g., psychosis, bipolar disorder)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ohio University
Athens, Ohio, 45701
Steven W Evans, Ph.D., 740-593-2186, evanss3@ohio.edu
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Brandon K Schultz, Ed.D., 252-737-4956, schultzb@ecu.edu
Christina Suggs, BA, 2523286876, suggsc@ecu.edu
About this study
Official title: Development of a Game-supported Intervention to Improve Learning and Study Strategies Among At-Risk Students
The investigators will develop and pilot test an innovative computer-assisted behavior intervention (CABI) for middle school students with attention-deficit/hyperactivity disorder (ADHD). The CABI will deliver evidence-based behavior interventions for ADHD in a manner that is acceptable to teachers and motivating for students. The key element of the CABI is a serious game that will teach and encourage rehearsal of ADHD coping skills in an engaging game environment. Transfer of those skills to authentic education settings will be facilitated by teacher interventionists in consultation with school or clinical psychologists. The investigators will test the CABI condition (n = 18) against traditional teacher consultation for ADHD (n = 18) on measures of consultation fidelity and student academic and behavioral outcomes.
Read the detailed description
An estimated 5% to 9.5% of school-age children in the United States have attention deficit hyperactivity disorder (ADHD), affecting 2.5 to 4.8 million public school students. ADHD is a costly disorder that often goes untreated, especially among adolescents. School-based behavior interventions can be efficacious, but there are persistent implementation challenges in those settings, resulting in a research-practice gap. Computer-based programs have emerged to potentially strengthen school-based intervention, but most target the neuropsychological correlates of ADHD (e.g., working memory deficits) rather than its impairments, with disappointing results. Designers have assumed that gains in neuropsychological functioning can indirectly alleviate ADHD impairments in real-world settings; the research, however, does not support this assumption. As an alternative, serious games might teach coping skills that directly remediate ADHD impairments, and then those new skills might be transferred to a target setting with the active assistance of interventionists. To date, game designers have not explored the latter approach.
This study will be the first to test an effort to actively transfer ADHD coping skills learned in a serious game to an authentic education setting. The game, called ATHEMOS, is based on the Challenging Horizons Program, which was inducted into SAMHSA's National Registry of Evidence-based Programs and Practices in 2010. The broad research aims are to (a) develop the serious game (ATHEMOS) that will teach evidence-based ADHD coping skills to adolescents; (b) test and revise initial versions of the game using feedback from focus groups and feasibility case studies; and (c) determine the degree to which these innovations achieve the benefits predicted. The last aim is the focus of this clinical trial registration, and will be achieved in a pilot study whereby middle school students with ADHD will be randomly assigned to receive the computer-assisted behavior intervention (CABI) or traditional school consultation for ADHD. The pilot study will occur at two sites (North Carolina and Ohio), with each site recruiting 18 participants. The investigators will verify ADHD diagnosis in an intake evaluation, randomly assign to conditions, and then begin school consultation with an identified teacher "mentor" for each case in the participating schools. After up to 16-weeks of intervention, the investigators will conduct an end-of-intervention evaluation. The data will be analyzed in a regression framework. Outcome measures at post-test will be regressed on pretest scores and a dummy variable representing condition. The slope of this dummy variable represents how change from pre to post-test differs across conditions. This approach provides a more powerful test of group differences in change than simple difference scores or analysis of variance. If after random assignment, one condition differs significantly from the other on an intake measure, the investigators may use that indicator as a covariate to adjust for this difference in subsequent analyses. The investigators will also assess clinical significance for all symptom and impairment measures to preliminarily compare the results to the relevant treatment literature.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Computer-assisted Behavior Intervention, Challenging Horizons Program
- 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.
Computer-assisted Behavior InterventionBehavioural
Also called ATHEMOS
The CABI includes a serious game called "ATHEMOS" that is designed to help students rehearse skills that ameliorate impairments associated with ADHD, including organization, scheduling, and note taking strategies. Once students have some experience with the game, a teacher consultee will help students actively transfer skills learned in the game to real-world classroom demands.
Challenging Horizons ProgramBehavioural
Also called CHP
The Challenging Horizons Program is an established psychosocial intervention package for young adolescents with ADHD, focusing on academic and behavioral impairments.
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted Behavior Intervention | Experimental | A serious game paired with teacher consultation to address common needs related to ADHD in the classroom. Receives: Behavioral: Computer-assisted Behavior Intervention |
| Challenging Horizons Program, School Consultation | Active comparator | An established teacher consultation program to help teachers address ADHD in the classroom. Receives: Behavioral: Challenging Horizons Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Classroom Performance Survey (CPS)
The Classroom Performance Survey (CPS) is a 15-item instrument that assesses the unique performance demands of secondary schools using 5-point Likert-type response formats. Research shows that the CPS is comprised of two subscales-referred to as academic competence (10 items; range = 10 - 50; M = 23.7; SD = 10.8) and interpersonal competence (5 items; range = 5 - 25; M = 9.5; SD = 4.8)-with high internal reliability (α = .98 and .91, respectively). Criterion-related validity with the Impairment Rating Scale, an established measure of functional impairment, concluded that the CPS was significantly and meaningfully related to that criterion (rs = .47 to .73) (Brady et al., 2012). Higher scores suggest greater degrees of academic impairment.
Measured: Baseline and 16 weeks
Change from baseline on the School Functioning Scale (SFS)
The School Functioning Scale (SFS) is a 10-item instrument that assesses school-related impairments in secondary schools using 5- or 6-point Likert type response formats (range = 9 to 47). Psychometric properties suggest that the SFS is a valid and reliable measure of school performance, with a single overall score (general factor; M = 38.2; SD = 7.0) accounting for the largest percent of variance, strongest reliability, and highest factor loading when compared to 2- and 3-factor models. Proposed subscales include a 5-item academic (M = 16.5; SD = 3.2), 3-item behavior (M = 6.2; SD = 3.1), and 2-item social factors (M = 9.9; SD = 2.2) (DuPaul et al., 2019). Higher scores represent more effective school functioning.
Measured: Baseline and 16 weeks
Change from baseline on the Children's Organizational Skills Scale--Parent Report (COSS-P)
The Children's Organizational Skills Scale--Parent Report (COSS-P) is a 66-item instrument that assesses children's organization, time management, and planning using 4-point Likert-type response formats. The COSS-P is comprised of psychometrically validated subscales, including Task Planning (6-items; range = 6 to 24), Organized Actions (10-items; range = 10 to 40), and Memory and Materials Management (10 items; range = 10 to 40). High scores on these subscales suggest greater levels of organization. In addition, an impairment scale is computed from 8 items (range = 8 to 32), where high scores suggest greater levels of impairment. An overall total score is derived from the 56 non-impairment items (range = 56 to 224), where high scores suggest greater levels of organization. The COSS-P was normed with a representative sample of parents, allowing a conversion from raw scores to T-scores (Molitor et al., 2017).
Measured: Baseline and 16 weeks
Secondary outcomes (4)
Change from baseline on the Working Alliance Inventory - Short Revised (WAI-SR)
The Working Alliance Inventory - Short Revised (WAI-SR) is a 12-item self-report measure of working alliance between therapists and client that will be modified for the present study to measure the relationship between students and their teacher mentors. The WAI-SR uses a 5-point Likert-type response format, producing a total score ranging from 12 to 60. The instrument has demonstrated adequate psychometric properties (e.g., Munder et al., 2010). The investigators will modify the language slightly for the purposes of the present study (e.g., changing "therapist" to "teacher mentor"). Higher scores represent better working alliance.
Measured: Baseline and 16 weeks
Group comparison of School Grades
Report card data from the participants, as provided by the participating schools. Grades are scaled on a 5-point scale, from A (4.0) to F (0.0). Any variation in that format will be rescaled to make the scores comparable across sites.
Measured: Up to 6 months
Group comparison of Satisfaction Questionnaire data
An 8-item satisfaction questionnaire used in previous studies of the Challenging Horizons Program administered to teachers, parents, and students. Each item uses a 4-point Likert-type response format, and total scores range from 8 to 32. Higher scores represent higher program satisfaction. Although the instrument has not been examined psychometrically, the feedback will be used to identify elements of the program that participants valued.
Measured: Up to 6 months
Descriptive single-group analysis of Technology Acceptance Model Instrument - Fast Form
A satisfaction questionnaire to assess the acceptability of a new technology, adapted to inquire specifically about the computer-assisted behavior intervention. Will be administered to teachers who participate in the experimental arm of the present study. The Technology Acceptance Model Instrument-Fast Form is comprised of 12-items, and each item uses a 7-point Likert-type response format ranging from -3 to +3. Total scores range from -36 to +36. Higher scores represent higher levels of instrument acceptability.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start27 Sep 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible families will be randomly assigned to either the CABI or traditional consultation condition. The investigators will use a two-wave cohort design, so that one-half of the sample will be randomly assigned to participate in the first semester (September to December) and the second half in the second semester (January to May), assuring that the proportion of students in each condition do not exceed a 5:4 ratio each semester. Participation will end with a post-intervention evaluation in December or May (depending on wave), thereby providing three total measurement occasions.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio University
- Responsible party
- Sponsor
- Investigators
- Brandon Schultz, Ed.D., Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048043
- Sponsor's protocol ID
- 18-001555
- Other IDs
- R324A180219
- Status last verified
- Sep 2021
- First submitted
- 2 Aug 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
PubMed 20013760DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.
PubMed 31045408Molitor SJ, Langberg JM, Evans SW, Dvorsky MR, Bourchtein E, Eddy LD, Smith ZR, Oddo LE. Evaluating the Factor Validity of the Children's Organizational Skills Scale in Youth with ADHD. School Ment Health. 2017 Jun;9(2):143-156. doi: 10.1007/s12310-016-9205-0. Epub 2016 Dec 27.
PubMed 28983327
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Game-supported Intervention to Improve Learning and Study Strategies Among At-Risk Students
- ClinicalTrials.gov ID
- NCT05048043
- Acronym / sponsor ID
- 18-001555
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Ohio University
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 17 Sep 2021 (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 investigators will develop and pilot test an innovative computer-assisted behavior intervention (CABI) for middle school students with attention-deficit/hyperactivity disorder (ADHD). The CABI will deliver evidence-based behavior interventions for ADHD in a manner that is acceptable to teachers and motivating for students. The key element of the CABI is a serious game that will teach and encourage rehearsal of ADHD coping skills in an engaging game environment. Transfer of those skills to authentic education settings will be facilitated by teacher interventionists in consultation with school or clinical psychologists. The investigators will test the CABI condition (n = 18) against traditional teacher consultation for ADHD (n = 18) on measures of consultation fidelity and student academic and behavioral outcomes.
Detailed description
An estimated 5% to 9.5% of school-age children in the United States have attention deficit hyperactivity disorder (ADHD), affecting 2.5 to 4.8 million public school students. ADHD is a costly disorder that often goes untreated, especially among adolescents. School-based behavior interventions can be efficacious, but there are persistent implementation challenges in those settings, resulting in a research-practice gap. Computer-based programs have emerged to potentially strengthen school-based intervention, but most target the neuropsychological correlates of ADHD (e.g., working memory deficits) rather than its impairments, with disappointing results. Designers have assumed that gains in neuropsychological functioning can indirectly alleviate ADHD impairments in real-world settings; the research, however, does not support this assumption. As an alternative, serious games might teach coping skills that directly remediate ADHD impairments, and then those new skills might be transferred to a target setting with the active assistance of interventionists. To date, game designers have not explored the latter approach.
This study will be the first to test an effort to actively transfer ADHD coping skills learned in a serious game to an authentic education setting. The game, called ATHEMOS, is based on the Challenging Horizons Program, which was inducted into SAMHSA's National Registry of Evidence-based Programs and Practices in 2010. The broad research aims are to (a) develop the serious game (ATHEMOS) that will teach evidence-based ADHD coping skills to adolescents; (b) test and revise initial versions of the game using feedback from focus groups and feasibility case studies; and (c) determine the degree to which these innovations achieve the benefits predicted. The last aim is the focus of this clinical trial registration, and will be achieved in a pilot study whereby middle school students with ADHD will be randomly assigned to receive the computer-assisted behavior intervention (CABI) or traditional school consultation for ADHD. The pilot study will occur at two sites (North Carolina and Ohio), with each site recruiting 18 participants. The investigators will verify ADHD diagnosis in an intake evaluation, randomly assign to conditions, and then begin school consultation with an identified teacher "mentor" for each case in the participating schools. After up to 16-weeks of intervention, the investigators will conduct an end-of-intervention evaluation. The data will be analyzed in a regression framework. Outcome measures at post-test will be regressed on pretest scores and a dummy variable representing condition. The slope of this dummy variable represents how change from pre to post-test differs across conditions. This approach provides a more powerful test of group differences in change than simple difference scores or analysis of variance. If after random assignment, one condition differs significantly from the other on an intake measure, the investigators may use that indicator as a covariate to adjust for this difference in subsequent analyses. The investigators will also assess clinical significance for all symptom and impairment measures to preliminarily compare the results to the relevant treatment literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible families will be randomly assigned to either the CABI or traditional consultation condition. The investigators will use a two-wave cohort design, so that one-half of the sample will be randomly assigned to participate in the first semester (September to December) and the second half in the second semester (January to May), assuring that the proportion of students in each condition do not exceed a 5:4 ratio each semester. Participation will end with a post-intervention evaluation in December or May (depending on wave), thereby providing three total measurement occasions.
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted Behavior Intervention | Experimental | Behavioral: Computer-assisted Behavior InterventionA serious game paired with teacher consultation to address common needs related to ADHD in the classroom. |
| Challenging Horizons Program, School Consultation | Active comparator | Behavioral: Challenging Horizons ProgramAn established teacher consultation program to help teachers address ADHD in the classroom. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All participants must meet DSM-5 criteria for ADHD (any presentation);
- A history of academic impairment (regardless of medication status)
Key exclusion criteria (3 listed)
- Estimated full-scale IQ less than 80;
- Plans to leave the school district during the study timeframe;
- Psychiatric conditions ill-suited to the proposed intervention (e.g., psychosis, bipolar disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted Behavior InterventionAlso: ATHEMOSThe CABI includes a serious game called "ATHEMOS" that is designed to help students rehearse skills that ameliorate impairments associated with ADHD, including organization, scheduling, and note taking strategies. Once students have some experience with the game, a teacher consultee will help students actively transfer skills learned in the game to real-world classroom demands. | Behavioural | Computer-assisted Behavior Intervention |
| Challenging Horizons ProgramAlso: CHPThe Challenging Horizons Program is an established psychosocial intervention package for young adolescents with ADHD, focusing on academic and behavioral impairments. | Behavioural | Challenging Horizons Program, School Consultation |
Primary outcome
Change from baseline on the Classroom Performance Survey (CPS)
Time frame: Baseline and 16 weeks
The Classroom Performance Survey (CPS) is a 15-item instrument that assesses the unique performance demands of secondary schools using 5-point Likert-type response formats. Research shows that the CPS is comprised of two subscales-referred to as academic competence (10 items; range = 10 - 50; M = 23.7; SD = 10.8) and interpersonal competence (5 items; range = 5 - 25; M = 9.5; SD = 4.8)-with high internal reliability (α = .98 and .91, respectively). Criterion-related validity with the Impairment Rating Scale, an established measure of functional impairment, concluded that the CPS was significantly and meaningfully related to that criterion (rs = .47 to .73) (Brady et al., 2012). Higher scores suggest greater degrees of academic impairment.
Change from baseline on the School Functioning Scale (SFS)
Time frame: Baseline and 16 weeks
The School Functioning Scale (SFS) is a 10-item instrument that assesses school-related impairments in secondary schools using 5- or 6-point Likert type response formats (range = 9 to 47). Psychometric properties suggest that the SFS is a valid and reliable measure of school performance, with a single overall score (general factor; M = 38.2; SD = 7.0) accounting for the largest percent of variance, strongest reliability, and highest factor loading when compared to 2- and 3-factor models. Proposed subscales include a 5-item academic (M = 16.5; SD = 3.2), 3-item behavior (M = 6.2; SD = 3.1), and 2-item social factors (M = 9.9; SD = 2.2) (DuPaul et al., 2019). Higher scores represent more effective school functioning.
Change from baseline on the Children's Organizational Skills Scale--Parent Report (COSS-P)
Time frame: Baseline and 16 weeks
The Children's Organizational Skills Scale--Parent Report (COSS-P) is a 66-item instrument that assesses children's organization, time management, and planning using 4-point Likert-type response formats. The COSS-P is comprised of psychometrically validated subscales, including Task Planning (6-items; range = 6 to 24), Organized Actions (10-items; range = 10 to 40), and Memory and Materials Management (10 items; range = 10 to 40). High scores on these subscales suggest greater levels of organization. In addition, an impairment scale is computed from 8 items (range = 8 to 32), where high scores suggest greater levels of impairment. An overall total score is derived from the 56 non-impairment items (range = 56 to 224), where high scores suggest greater levels of organization. The COSS-P was normed with a representative sample of parents, allowing a conversion from raw scores to T-scores (Molitor et al., 2017).
4 secondary outcomes
Change from baseline on the Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: Baseline and 16 weeks
Group comparison of School Grades
Time frame: Up to 6 months
Group comparison of Satisfaction Questionnaire data
Time frame: Up to 6 months
Descriptive single-group analysis of Technology Acceptance Model Instrument - Fast Form
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 20013760Munder T, Wilmers F, Leonhart R, Linster HW, Barth J. Working Alliance Inventory-Short Revised (WAI-SR): psychometric properties in outpatients and inpatients. Clin Psychol Psychother. 2010 May-Jun;17(3):231-9. doi: 10.1002/cpp.658.
- Background: PubMed 31045408DuPaul GJ, Evans SW, Allan D, Puzino K, Xiang J, Cooper J, Owens JS. High school teacher ratings of academic, social, and behavioral difficulties: Factor structure and normative data for the School Functioning Scale. Sch Psychol. 2019 Sep;34(5):479-491. doi: 10.1037/spq0000323. Epub 2019 May 2.
- Background: PubMed 28983327Molitor SJ, Langberg JM, Evans SW, Dvorsky MR, Bourchtein E, Eddy LD, Smith ZR, Oddo LE. Evaluating the Factor Validity of the Children's Organizational Skills Scale in Youth with ADHD. School Ment Health. 2017 Jun;9(2):143-156. doi: 10.1007/s12310-016-9205-0. Epub 2016 Dec 27.
- 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.
Brandon Schultz, Ed.D. principal investigator
East Carolina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted Behavior Intervention and Challenging Horizons Program in people with Attention Deficit Hyperactivity Disorder, run by East Carolina University at 2 sites in United States.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Office of Research Integrity and Compliance (2527442914, oric@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the Classroom Performance Survey (CPS) (time frame: Baseline and 16 weeks). The study lists 3 primary outcomes in all. 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 NCT05048043, which also lists 3 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 17 Feb 2022.