Attention Deficit and Disruptive Behavior DisordersPEARNCT07203014
Parent-Educator Action Response
A study testing Parent-Educator Action Response (PEAR) and Daily Report Card in people with Attention Deficit and Disruptive Behavior Disorders, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a new adjunctive intervention, Parent-Educator Action Response (PEAR), works to improve teacher and family engagement in school-based interventions for child attention deficit/hyperactivity disorder (ADHD) and disruptive behavior symptoms. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Parent-Educator Action Response (PEAR) and Daily Report Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Teacher or legal guardian/caregiver of a preschool-aged child between 2-5 years old
- Child has behavioral challenges in the classroom or needs support with social-emotional development
- Teacher participants must be fluent in English
- Caregiver participants may be fluent in English or Spanish.
Who cannot join
- Teacher or legal guardian/caregiver of a child who is not 2-5 years old
- Child does not have behavioral challenges or does not need support with social-emotional development
- Teacher participants who are not fluent in English
- Caregiver participants who are not fluent in either English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
About this study
Official title: Testing a Brief, Engagement Focused Intervention for Parents and Educators in Preschool: Parent-Educator Action Response
The goal of this clinical trial is to learn if a new adjunctive intervention, Parent-Educator Action Response (PEAR), works to improve teacher and family engagement in school-based interventions for child attention deficit/hyperactivity disorder (ADHD) and disruptive behavior symptoms. This clinical trial will also be used to refine implementation procedures to inform a larger clinical trial.
Read the detailed description
School-based behavioral interventions are well-established treatments for preschool children who display elevated ADHD symptoms, regardless of a diagnosis, and are the recommended first line of treatment according to the American Academy of Pediatrics. However, teachers and families face barriers to implementing behavioral interventions with the recommended frequency and fidelity. The investigators are proposing to test a new adjunctive intervention that is aimed at improving teacher and family implementation of school-based interventions for preschool disruptive behavior and ADHD symptoms. The investigators will be testing PEAR plus a school-based intervention (Daily Report Card; DRC) in a pilot roll-out implementation optimization (ROIO) trial with three clusters (groups of schools) across two years.
Adjunctive Intervention (PEAR). All participating parents and teachers will complete PEAR. PEAR consists of three group sessions (one for caregivers and one for educators) followed by a meeting with each caregiver-educator dyad.
Daily Report Card. The primary goal of PEAR is to improve teacher and family implementation of an evidence-based practice for ADHD symptoms in preschool. The investigators have decided to focus on implementation of the Daily Report Card. Following consent, teachers will receive handouts on the Daily Report Card and will be asked to implement it for the child whose parents are in PEAR. Teachers and parents will be asked to complete weekly reports measuring teacher and family daily use of the DRC starting at BL through the 4-week follow up (8 weeks total).
Assessment Procedures. Assessments will be completed at three time points: BL (week 0), post-PEAR (4 weeks from BL), and follow-up (8 weeks from BL). At each assessment, participating legal guardians and teachers will complete rating scales electronically via RedCap, a scalable, secure, enterprise-level application for data collection. Interviews: Qualitative interviews with parents and teachers who participate in PEAR will be conducted to understand their experiences and identify potential areas for improvement.
Analytic Approach. This clinical trial will specifically examine the acceptability, feasibility and promise of PEAR and refine and optimize trial procedures. Basic data screening and descriptive analyses will be conducted for all variables, and the investigators will screen for errors, distributional form, and missing data. For all models, the investigators will check assumptions to ensure that results are not an artifact of violations. Below are analytic details for each aim of the trial:
Is PEAR and the implementation strategies acceptable and feasible? Overall, PEAR acceptability and feasibility for all participants will be evaluated by examining the mean parent and teacher ratings of satisfaction, acceptability, appropriateness, and feasibility. Consumer fit will be considered acceptable if scores are above the neutral point of the scale for all measures except fidelity, which the investigators will consider 80% as the target point. The investigators will also examine whether acceptability and feasibility indices vary by classroom and participant demographics by treating these predictors as fixed effects in regression analyses.
Are the ROIO trial procedures acceptable and feasible? This aim is focused on (a) refining recruitment procedures and study protocol to obtain an adequate sample of parents, (b) optimizing screening and assessment procedures in preschool, and (c) optimizing procedures for sustaining participants in PEAR (i.e., minimizing drop-out).
Does PEAR improve teacher and family fidelity to the Daily Report Card? The investigators will collect daily (weekdays only) counts of family and teacher implementation of the Daily Report Card starting at BL through follow-up (8 weeks total). Fidelity will be defined as the proportion of weekdays the Daily Report Card is implemented at home, school, and both. The investigators are interested in examining the change in fidelity across time. Hierarchical multi-level models will be used to ensure inclusion of random effects, variations between clusters, variation between times within cluster, and fixed effects of time which will be estimated independently of treatment effect, so that systematic change over time will not be mistaken for the effect of treatment.
- Being tested
- Parent-Educator Action Response (PEAR), Daily Report Card
- Keywords
- adjunctive intervention, Preschool ADHD symptoms, Disruptive Behavior, Parent-teacher relationship, Daily Report Card
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Educator Action Response (PEAR)Behavioural
PEAR is a novel adjunctive intervention aimed at improving teacher and family implementation of classroom-based interventions for child ADHD symptoms and disruptive behavior in preschool.
Daily Report CardBehavioural
The Daily Report Card is a behavioral intervention for children with challenging behaviors, and provides a structure for teachers and caregivers to support a child with reducing challenging behaviors and increasing positive behaviors. The DRC has been shown to be highly effective in reducing ADHD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| PEAR intervention group | Experimental | All participants will receive the Daily Report Card plus PEAR. PEAR is delivered via group sessions in which participants will be guided through content with a licensed clinical psychologist and will complete activities and receive handouts for reference. Receives: Behavioral: Parent-Educator Action Response (PEAR); Behavioral: Daily Report Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Report Card Check-In
The Daily Report Card (DRC) check-in is a weekly survey developed by the investigators that measures daily uptake of DRC usage among parents and teachers across home and school.
Measured: Baseline to 8-week follow-up
Secondary outcomes (11)
Preschool Pediatric Symptom Checklist
Teachers and parents will complete the Preschool Pediatric Symptom Checklist to evaluate overall child behavior. The Preschool Pediatric Symptom Checklist is an 18-item scale with answer choices of 0 = Not at all to 2 = Very much. Items are summed to obtain a score; authors recommend a clinical cutoff score of 9 (highest possible score is 36).
Measured: Baseline, 4-week, 8-week follow-ups.
Preschool ADHD Rating Scale Version IV (ADHD-RS-IV)
Teachers and parents will complete the Preschool ADHD-RS-IV to measure child ADHD symptoms of children 3-5 years old. The Preschool ADHD-RS-IV is an 18-item scale with answer choices from 0 = rarely or never to 3 = very often. Total score is the sum of all 18 items, odd numbered items measure inattention and even numbered items measure hyperactivity/inactivity. 93rd percentile cutoff scores for boys are as follows: 32 (parent) and 38 (teacher); 93rd percentile cutoff scores for girls are as follows: 24 (parent) and 24 (teacher).
Measured: Baseline, 4-week, 8-week follow-ups.
Teacher-Parent Joining
Teachers and parents will complete the Parent-Teacher Relationship Scale II to measure the quality of parent-teacher relationships. This 24-item scale includes answer choices from 1 = almost never to 5 = almost always.
Measured: Baseline, 4-week, 8-weeks follow-ups.
Teacher Self-Efficacy for Classroom Behavior Management
Teachers will complete the Teacher Self-Efficacy Scale - Classroom Management measure to rate their self-efficacy in managing classroom behaviors. The 8-item scale ranges from 1 = Nothing to 9= A great deal; higher scores indicate greater self-efficacy.
Measured: Baseline, 4-week, 8-week follow-ups.
Teacher Burnout
Teachers will complete the West Virginia Teacher Burnout Scale to measure teacher burnout. This 20-item scale uses a 5 item Likert scale of 1= strongly disagree to 5= strongly agree. Scores range from 20-80; higher scores indicate greater feelings of burnout.
Measured: Baseline, 4-week, 8-week follow-ups.
Racial Awareness, Beliefs, and Attitudes
Teachers will complete a three-part measure to assess their racial awareness, beliefs, and attitudes. Part 1 has 10 items and uses a 4-point Likert scale from 1= strongly disagree to 4= strongly agree; part 2 has 20 items and uses a 6-point Likert scale from 1= strongly disagree to 6=strongly agree; part 3 has 12 items and uses a 6-point Likert scale from 1= strongly disagree to 6=strongly agree.
Measured: Baseline, 4-week, 8-week follow-ups.
Parent Self-Efficacy
Parents will complete the Tool to Measure Parenting Self-Efficacy (TOPSE) subscales of discipline/setting boundaries and control to measure parenting self-efficacy around conflict. The subscales have 6 items each on a 0-10 point scale, and higher scores indicate greater parenting self-efficacy.
Measured: Baseline, 4-week, 8-week follow-ups.
Parenting Stress
Parents will complete the Parental Stress Scale to measure parental stress. The scale is composed of 18 items, with answers from 1 = strongly disagree to 5 = strongly agree. Scores range from 18-90, with higher scores indicating greater levels of stress.
Measured: Baseline, 4-week, 8-week follow-ups.
Top Problems
Parents and teachers will complete the Top Problems scale (developed by the investigators) to rate child behavior on the top three behaviors selected to monitor on the Daily Report Card plus overall behavior. Items are scored with a 7-point Likert scale from -3 = much worse to 3 = much better.
Measured: 4-week and 8-week follow-ups.
Expulsion Risk
Teachers will complete the Preschool Expulsion Risk Measure to evaluate perceptions of child expulsion risk. The measure has 12 items, with answer choices on a 5-point Likert scale from 1 = strongly disagree to 5 = strongly agree.
Measured: Baseline, 4-week, 8-week follow-ups.
Implementation Outcomes
Participants will complete an Implementation Outcomes survey to evaluate the acceptability, feasibility, and appropriateness of PEAR and provide feedback on potential changes in the procedures.
Measured: 4-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start2 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit and Disruptive Behavior DisordersStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study uses a pilot roll-out implementation optimization (ROIO) design. A ROIO is a novel methodological innovation that provides a rigorous solution to optimization via iterative, rapid incorporation of partner input throughout implementation in pursuit of effective, affordable, scalable, and efficient outcomes. There will be three clusters over the course of the trial. Each cluster will contain 1-3 early childhood centers. Teachers from each classroom within each center will be recruited and 1-4 families will be recruited from each classroom that has a participating teacher. All participants will receive information on the Daily Report Card followed by the new adjunctive intervention (PEAR). There is no control group.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Courtney Zulauf-McCurdy, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203014
- Sponsor's protocol ID
- STUDY00000176
- Other IDs
- K23MH129575
- Acronym
- PEAR
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisenman SR, Vanegas J, Cicchetti C, Compton SN, Gilliam WS, Iruka IU, Lyon AR, Wakschlag LS, Smith JD, Spencer AE, Zulauf-McCurdy CA. A pilot Roll-Out Implementation Optimization trial of an adjunctive intervention to improve teacher and caregiver uptake and adherence to a behavioral intervention for externalizing problems in preschool: a study protocol of Parent-Educator Action Response (PEAR). Implement Sci Commun. 2026 Apr 22;7(1):110. doi: 10.1186/s43058-026-00938-7.
PubMed 42021370
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Brief, Engagement Focused Intervention for Parents and Educators in Preschool: Parent-Educator Action Response
- ClinicalTrials.gov ID
- NCT07203014
- Acronym / sponsor ID
- PEAR / STUDY00000176
- Keywords
- adjunctive intervention, Preschool ADHD symptoms, Disruptive Behavior, Parent-teacher relationship, Daily Report Card
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Oct 2025 (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 clinical trial is to learn if a new adjunctive intervention, Parent-Educator Action Response (PEAR), works to improve teacher and family engagement in school-based interventions for child attention deficit/hyperactivity disorder (ADHD) and disruptive behavior symptoms. This clinical trial will also be used to refine implementation procedures to inform a larger clinical trial.
Detailed description
School-based behavioral interventions are well-established treatments for preschool children who display elevated ADHD symptoms, regardless of a diagnosis, and are the recommended first line of treatment according to the American Academy of Pediatrics. However, teachers and families face barriers to implementing behavioral interventions with the recommended frequency and fidelity. The investigators are proposing to test a new adjunctive intervention that is aimed at improving teacher and family implementation of school-based interventions for preschool disruptive behavior and ADHD symptoms. The investigators will be testing PEAR plus a school-based intervention (Daily Report Card; DRC) in a pilot roll-out implementation optimization (ROIO) trial with three clusters (groups of schools) across two years.
Adjunctive Intervention (PEAR). All participating parents and teachers will complete PEAR. PEAR consists of three group sessions (one for caregivers and one for educators) followed by a meeting with each caregiver-educator dyad.
Daily Report Card. The primary goal of PEAR is to improve teacher and family implementation of an evidence-based practice for ADHD symptoms in preschool. The investigators have decided to focus on implementation of the Daily Report Card. Following consent, teachers will receive handouts on the Daily Report Card and will be asked to implement it for the child whose parents are in PEAR. Teachers and parents will be asked to complete weekly reports measuring teacher and family daily use of the DRC starting at BL through the 4-week follow up (8 weeks total).
Assessment Procedures. Assessments will be completed at three time points: BL (week 0), post-PEAR (4 weeks from BL), and follow-up (8 weeks from BL). At each assessment, participating legal guardians and teachers will complete rating scales electronically via RedCap, a scalable, secure, enterprise-level application for data collection. Interviews: Qualitative interviews with parents and teachers who participate in PEAR will be conducted to understand their experiences and identify potential areas for improvement.
Analytic Approach. This clinical trial will specifically examine the acceptability, feasibility and promise of PEAR and refine and optimize trial procedures. Basic data screening and descriptive analyses will be conducted for all variables, and the investigators will screen for errors, distributional form, and missing data. For all models, the investigators will check assumptions to ensure that results are not an artifact of violations. Below are analytic details for each aim of the trial:
Is PEAR and the implementation strategies acceptable and feasible? Overall, PEAR acceptability and feasibility for all participants will be evaluated by examining the mean parent and teacher ratings of satisfaction, acceptability, appropriateness, and feasibility. Consumer fit will be considered acceptable if scores are above the neutral point of the scale for all measures except fidelity, which the investigators will consider 80% as the target point. The investigators will also examine whether acceptability and feasibility indices vary by classroom and participant demographics by treating these predictors as fixed effects in regression analyses.
Are the ROIO trial procedures acceptable and feasible? This aim is focused on (a) refining recruitment procedures and study protocol to obtain an adequate sample of parents, (b) optimizing screening and assessment procedures in preschool, and (c) optimizing procedures for sustaining participants in PEAR (i.e., minimizing drop-out).
Does PEAR improve teacher and family fidelity to the Daily Report Card? The investigators will collect daily (weekdays only) counts of family and teacher implementation of the Daily Report Card starting at BL through follow-up (8 weeks total). Fidelity will be defined as the proportion of weekdays the Daily Report Card is implemented at home, school, and both. The investigators are interested in examining the change in fidelity across time. Hierarchical multi-level models will be used to ensure inclusion of random effects, variations between clusters, variation between times within cluster, and fixed effects of time which will be estimated independently of treatment effect, so that systematic change over time will not be mistaken for the effect of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses a pilot roll-out implementation optimization (ROIO) design. A ROIO is a novel methodological innovation that provides a rigorous solution to optimization via iterative, rapid incorporation of partner input throughout implementation in pursuit of effective, affordable, scalable, and efficient outcomes. There will be three clusters over the course of the trial. Each cluster will contain 1-3 early childhood centers. Teachers from each classroom within each center will be recruited and 1-4 families will be recruited from each classroom that has a participating teacher. All participants will receive information on the Daily Report Card followed by the new adjunctive intervention (PEAR). There is no control group.
| Arm | Type | Receives |
|---|---|---|
| PEAR intervention group | Experimental | Behavioral: Parent-Educator Action Response (PEAR), Behavioral: Daily Report CardAll participants will receive the Daily Report Card plus PEAR. PEAR is delivered via group sessions in which participants will be guided through content with a licensed clinical psychologist and will complete activities and receive handouts for reference. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Teacher or legal guardian/caregiver of a preschool-aged child between 2-5 years old
- Child has behavioral challenges in the classroom or needs support with social-emotional development
- Teacher participants must be fluent in English
- Caregiver participants may be fluent in English or Spanish.
Key exclusion criteria (4 listed)
- Teacher or legal guardian/caregiver of a child who is not 2-5 years old
- Child does not have behavioral challenges or does not need support with social-emotional development
- Teacher participants who are not fluent in English
- Caregiver participants who are not fluent in either English or Spanish
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 |
|---|---|---|
| Parent-Educator Action Response (PEAR)PEAR is a novel adjunctive intervention aimed at improving teacher and family implementation of classroom-based interventions for child ADHD symptoms and disruptive behavior in preschool. | Behavioural | PEAR intervention group |
| Daily Report CardThe Daily Report Card is a behavioral intervention for children with challenging behaviors, and provides a structure for teachers and caregivers to support a child with reducing challenging behaviors and increasing positive behaviors. The DRC has been shown to be highly effective in reducing ADHD symptoms. | Behavioural | PEAR intervention group |
Primary outcome
Daily Report Card Check-In
Time frame: Baseline to 8-week follow-up
The Daily Report Card (DRC) check-in is a weekly survey developed by the investigators that measures daily uptake of DRC usage among parents and teachers across home and school.
11 secondary outcomes
Preschool Pediatric Symptom Checklist
Time frame: Baseline, 4-week, 8-week follow-ups.
Preschool ADHD Rating Scale Version IV (ADHD-RS-IV)
Time frame: Baseline, 4-week, 8-week follow-ups.
Teacher-Parent Joining
Time frame: Baseline, 4-week, 8-weeks follow-ups.
Teacher Self-Efficacy for Classroom Behavior Management
Time frame: Baseline, 4-week, 8-week follow-ups.
Teacher Burnout
Time frame: Baseline, 4-week, 8-week follow-ups.
Racial Awareness, Beliefs, and Attitudes
Time frame: Baseline, 4-week, 8-week follow-ups.
Parent Self-Efficacy
Time frame: Baseline, 4-week, 8-week follow-ups.
Parenting Stress
Time frame: Baseline, 4-week, 8-week follow-ups.
Top Problems
Time frame: 4-week and 8-week follow-ups.
Expulsion Risk
Time frame: Baseline, 4-week, 8-week follow-ups.
Implementation Outcomes
Time frame: 4-week follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 42021370Eisenman SR, Vanegas J, Cicchetti C, Compton SN, Gilliam WS, Iruka IU, Lyon AR, Wakschlag LS, Smith JD, Spencer AE, Zulauf-McCurdy CA. A pilot Roll-Out Implementation Optimization trial of an adjunctive intervention to improve teacher and caregiver uptake and adherence to a behavioral intervention for externalizing problems in preschool: a study protocol of Parent-Educator Action Response (PEAR). Implement Sci Commun. 2026 Apr 22;7(1):110. doi: 10.1186/s43058-026-00938-7.
- 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?
A study testing Parent-Educator Action Response (PEAR) and Daily Report Card in people with Attention Deficit and Disruptive Behavior Disorders, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Daily Report Card Check-In (time frame: Baseline to 8-week follow-up). 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 NCT07203014, which also lists 1 linked publication.
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 26 Oct 2026.