Attention Deficit Hyperactivity Disorder SymptomsNCT05489081
Implementation Strategy Resource Package for Behavioral Classroom Interventions: Pilot Test
A study testing Positive Behavior Management Toolkit in people with Attention Deficit Hyperactivity Disorder Symptoms, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder Symptoms
- What is being tested?
- Positive Behavior Management Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2022to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teachers:
- A K-5 teacher at a participating school within the School District of Philadelphia
- Teach at a participating school
- Informed consent
- Children:
- Is in a K-5 class of a participating teacher
Show all 16Show fewer
- Nominated for participation by the participating teacher
- Identified by their participating teacher as displaying impairment related to inattention, hyperactivity or impulsivity
- Informed consent and assent if appropriate
- Parents/Legal Guardians:
- Parent or legal guardian of child
- Identifies as familiar enough with the child to fill out measures about the child
- Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study
- Caregivers:
- Has been referred by the legal guardian as the primary caregiver that can more accurately complete the measures about the child
- Has mental capacity to provide consent for the participation of child in the study and for their own participation in the study
Who cannot join
- Children:
- Special education classification of 'intellectual disability'
- Primary presenting concern of psychotic or autism spectrum disorders
- Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because they warrant more intensive intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
Official title: Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.
Read the detailed description
Schools are an accessible and ecologically valid setting for children with hyperactivity, inattentive, or impulsive behaviors to receive evidence-based interventions to reduce symptoms and improve functioning. Behavioral classroom management interventions are well-established treatments for elementary-school age children with, but they can often be challenging for teachers to use. It is therefore important to develop and test implementation strategies in promoting teachers' use of behavioral classroom management interventions and in improving child outcomes. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.
- Being tested
- Positive Behavior Management Toolkit
- Keywords
- Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Positive Behavioral Interventions and Supports, Behavioral Classroom Management, Inattentive, Hyperactive, Impulsive
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Spasm, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Behavior Management ToolkitBehavioural
Also called Implementation Strategy Resource Package, Support School Success - Teacher Version (SSS-T)
The Positive Behavior Management Toolkit, or the implementation strategy resource package, is a set of resources provided to teachers in the intervention group that aims to support their use of positive behavior management practices in the classroom, particularly with students with hyperactive, inattentive, or impulsive behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Implementation Resource Package Group | Experimental | Teachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be students nested in the classrooms of the teachers that are assigned to the intervention group. Receives: Behavioral: Positive Behavior Management Toolkit |
| Control Group | No intervention | Within the control group (no intervention), teachers in this group will not receive the implementation support package nor extra support during the study period. They will continue to receive implementation support as usual. Also within the control group (no intervention) will be students nested in the classrooms of the teachers that are assigned to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Acceptability of Intervention Measure (AIM)
Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Intervention Appropriateness Measure (IAM)
Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Observed Teacher Use of Behavioral Classroom Management Interventions
A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions.
Measured: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Caregiver-reported Child Functional Impairment
Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range: 1 through 5, where 1 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Teacher-reported Child Functional Impairment
Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Academic Productivity
Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Student-Teacher Relationship
Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). Eight items are reverse score, and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Feasibility of Research Procedures - Recruitment Numbers
Number of teachers and students enrolled in the study
Measured: Baseline
Feasibility of Research Procedures - Response Rate
Percentage of parent- and teacher- report surveys completed across timepoints and conditions out of the number of students enrolled and randomized.
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Feasibility of Research Procedures - Retention Rate
Percentage of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions
Measured: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Secondary outcomes (5)
Change in Homework Performance
Caregiver-reported student self-regulation factor on the Homework Performance Questionnaire - Parent Version for students in grades 1-5. The self-regulation factor consists of 9 items, each rated on a 4-point scale (0 = rarely/never, 1 = some of the time, 2 = most of the time, 3 = always/almost always). Four items are reverse scored, and then the self-regulation factor score is computed as the average of the 9 item scores (possible range: 0 through 3, where 3 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Caregiver-reported ADHD Symptoms
Caregiver-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the 18 item scores (possible range: 0 through 3, where 0 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD Symptoms
Teacher-reported inattention and hyperactivity/impulsivity symptom scores on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version, which consists of 18 items, rated on a 4-point scale (from 0 = Never to 3 = Very Often). The total score is calculated as the average of the 18 item scores (possible range: 0 through 3, where 0 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Academic Success
Teacher-reported Academic Success subscale score of the Academic Performance rating Scale (APRS). The Academic Success subscale includes 7 items, each rated on a 5-point Likert scale from 1 to 5. One item is reverse scored, and the total score is computed as the average of the 7 items (possible range: 1 through 5, where 5 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Disruptive Direct Behavior Ratings
Teacher-reported ratings on the disruptive behavior domain of Direct Behavior Rating Multi-Item Scales, which consist of 5 items on a 6-point scale (from 0 = "not a problem" to 6 = "serious problem"). The total score is computed as the average of the 5 items (possible range: 0 through 6, where 0 is the best possible outcome).
Measured: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start20 Sep 2022
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder SymptomsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating teachers, and the students nested within their classroom, are randomized to one of two conditions: implementation strategy resource package or support as usual.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gwendolyn M Lawson, PhD, Principal investigator, Children's Hospital of Philadelphia/University of Pennsylvania Perelman School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489081
- Sponsor's protocol ID
- 22-019825
- Other IDs
- K23MH122577
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2022
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lawson GM, Owens JS, Mandell DS, Tavlin S, Rufe S, Lyon AR, Eiraldi R, Power TJ. Implementation resources to support teachers' use of behavioral classroom interventions: protocol of a randomized pilot trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):151. doi: 10.1186/s40814-023-01381-4.
PubMed 37626422
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Implementation of Behavioral Classroom Interventions for Children With ADHD in Urban Schools: A Pilot Test, Aim 3
- ClinicalTrials.gov ID
- NCT05489081
- Acronym / sponsor ID
- 22-019825
- Keywords
- Attention Deficit Hyperactivity Disorder, Positive Behavior Management, Positive Behavioral Interventions and Supports, Behavioral Classroom Management, Inattentive, Hyperactive, Impulsive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Posted 29 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.
Detailed description
Schools are an accessible and ecologically valid setting for children with hyperactivity, inattentive, or impulsive behaviors to receive evidence-based interventions to reduce symptoms and improve functioning. Behavioral classroom management interventions are well-established treatments for elementary-school age children with, but they can often be challenging for teachers to use. It is therefore important to develop and test implementation strategies in promoting teachers' use of behavioral classroom management interventions and in improving child outcomes. The purpose of this study is to pilot test for feasibility and initial promise an implementation strategy resource package that aims to support teachers in using behavioral classroom management interventions for children with hyperactive, inattentive, or impulsive behaviors. Participating teachers will be randomized to receive the resource package or support as usual and the research team will examine, a) teacher implementation of behavioral classroom interventions and b) mental health outcomes for enrolled children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating teachers, and the students nested within their classroom, are randomized to one of two conditions: implementation strategy resource package or support as usual.
| Arm | Type | Receives |
|---|---|---|
| Implementation Resource Package Group | Experimental | Behavioral: Positive Behavior Management ToolkitTeachers in this group will receive an implementation support package and receive support in using it within their classroom management practice. Also within the intervention group (experimental), will be students nested in the classrooms of the teachers that are assigned to the intervention group. |
| Control Group | No intervention | –Within the control group (no intervention), teachers in this group will not receive the implementation support package nor extra support during the study period. They will continue to receive implementation support as usual. Also within the control group (no intervention) will be students nested in the classrooms of the teachers that are assigned to the control group. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- A K-5 teacher at a participating school within the School District of Philadelphia
- Teach at a participating school
- Informed consent
- Is in a K-5 class of a participating teacher
- Nominated for participation by the participating teacher
Key exclusion criteria (4 listed)
- Special education classification of 'intellectual disability'
- Primary presenting concern of psychotic or autism spectrum disorders
- Presents as in acute risk of harm to self or others, such that participation in the study is clinically inappropriate because they warrant more intensive intervention
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 |
|---|---|---|
| Positive Behavior Management ToolkitAlso: Implementation Strategy Resource Package, Support School Success - Teacher Version (SSS-T)The Positive Behavior Management Toolkit, or the implementation strategy resource package, is a set of resources provided to teachers in the intervention group that aims to support their use of positive behavior management practices in the classroom, particularly with students with hyperactive, inattentive, or impulsive behaviors. | Behavioural | Implementation Resource Package Group |
Primary outcome
Feasibility of Intervention Measure
Time frame: Endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported total score on the Feasibility of Intervention Measure (FIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Acceptability of Intervention Measure (AIM)
Time frame: Endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported total score on the Acceptability of Intervention Measure (AIM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Intervention Appropriateness Measure (IAM)
Time frame: Endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported total score on the Intervention Appropriateness Measure (IAM), which consists of 4 items on a 5-point Likert scale (from 1 = Completely Disagree to 5 = Completely Agree). The total score is the average of the 4 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Change in Observed Teacher Use of Behavioral Classroom Management Interventions
Time frame: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
A member of the study will conduct classroom observations to measure fidelity of teacher use of the behavioral classroom management interventions.
Change in Caregiver-reported Child Functional Impairment
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Caregiver-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Parent Version; These 7 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 7 item scores (possible range: 1 through 5, where 1 is the best possible outcome).
Change in Teacher-reported Child Functional Impairment
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported performance items on the National Institute for Children's Health Quality Vanderbilt Scale - Teacher Version; These 8 items are rated on a 5-point scale (from 1 = Excellent to 5 = Problematic). The total score is the average of the 8 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Change in Academic Productivity
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported Academic Productivity subscale score of the Academic Performance Rating Scale (APRS). The Academic Productivity subscale includes 12 items, each rated on a 5-point Likert scale from 1 to 5. Four items are reverse scored, and the total score is computed as the average of the 12 items (possible range: 1 through 5, where 5 is the best possible outcome).
Change in Student-Teacher Relationship
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Teacher-reported total score on the Student-Teacher Relationship Scale - Short form, which consists of 15 items, rated on a 5-point scale (from 1 = Definitely does not apply to 5 = Definitely applies). Eight items are reverse score, and then the total score is computed as the average of the 15 item scores (possible range: 1 through 5, where 5 is the best possible outcome).
Feasibility of Research Procedures - Recruitment Numbers
Time frame: Baseline
Number of teachers and students enrolled in the study
Feasibility of Research Procedures - Response Rate
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Percentage of parent- and teacher- report surveys completed across timepoints and conditions out of the number of students enrolled and randomized.
Feasibility of Research Procedures - Retention Rate
Time frame: Baseline, midpoint (i.e., up to 7 weeks from resource package receipt), endpoint (i.e, at least 8 weeks from resource package receipt)
Percentage of participants who do not withdraw out of the number of enrolled and randomized teachers and students across conditions
5 secondary outcomes
Change in Homework Performance
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Caregiver-reported ADHD Symptoms
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Teacher-reported ADHD Symptoms
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Academic Success
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Change in Disruptive Direct Behavior Ratings
Time frame: Baseline, endpoint (i.e, at least 8 weeks from resource package receipt)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37626422Lawson GM, Owens JS, Mandell DS, Tavlin S, Rufe S, Lyon AR, Eiraldi R, Power TJ. Implementation resources to support teachers' use of behavioral classroom interventions: protocol of a randomized pilot trial. Pilot Feasibility Stud. 2023 Aug 25;9(1):151. doi: 10.1186/s40814-023-01381-4.
- Individual participant dataSharing planned: Undecided
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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.
Gwendolyn M Lawson, PhD principal investigator
Children's Hospital of Philadelphia/University of Pennsylvania Perelman School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Behavior Management Toolkit in people with Attention Deficit Hyperactivity Disorder Symptoms, run by Children's Hospital of Philadelphia 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 16 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: finished, as of the sponsor's last update on 29 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Intervention Measure (time frame: Endpoint (i.e, at least 8 weeks from resource package receipt)). The study lists 11 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 NCT05489081, 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 29 Jul 2025.