First Episode Psychosis (FEP)NCT07749105
Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies
A study testing Thinking Skills for Work-Cognitive Self-Management Program (CSM) and Treatment as Usual (TAU) in people with First Episode Psychosis (FEP), run by Boston University Charles River Campus at 4 sites in United States.
Trial summary
The goal of this pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young… Read more about this study
- Who is it for?
- Ages 15 to 32 years
- Conditions the study is for
- First Episode Psychosis (FEP)
- What is being tested?
- Thinking Skills for Work-Cognitive Self-Management Program (CSM) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Aug 2025to 31 May 2029
- 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 15 to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- currently in their first 18 months of enrollment in the CSC program
- at least 15 years of age
- receiving SEE services but not employed or enrolled in school
- have the desire to work or resume school.
Who cannot join
- 1) Young adults who are not fluent in english
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
West Texas Centers Promoting Behavioral and Developmental Health
Big Spring, Texas, 79720
Monique Gusman, 1-800-852-2193, monique.gusman@wtcmhmr.org
Amanda Ryan, PhD
- Recruiting
Pecan Valley Centers for Behavioral and Developmental Healthcare
Granbury, Texas, 76048
David Risner, 817-579-4400, drisner@pecanvalley.org
Amanda Ryan, PhD, amanda.ryan@austin.utexas.edu
- Recruiting
Border Region Behavioral Health Care
Laredo, Texas, 78041
Janie Hernandez, 956-794-3178, sanjuanah@borderregion.org
Amanda Ryan, PhD, amanda.ryan@austin.utexas.edu
- Not yet recruiting
Community Healthcore
Longview, Texas, 75604
Jaime Jaggers, 903-237-2326, Jaime.Jaggers@CommunityHealthcore.com
Amanda Ryan, PhD
About this study
Official title: Enhancing Cognitive and Work/School Outcomes in People With First Episode Psychosis: Testing the Effectiveness of Cognitive Self-Management Strategies
The goal of this pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young adults experiencing first episode psychosis. The main questions it aims to answer are:
- Does adding the CSM program to usual SEE services lead to improved work and school outcomes, such as ability to find a job or enroll in school, or ability to keep a job or stay in school?
- Does adding the CSM program to usual SEE services improve cognition and cognitive self-efficacy? Researchers will recruit six research sites and these will be randomized to either treatment as usual, where they will offer regular SEE services, or the experimental groups, where they will offer regular SEE services plus the CSM program.
Participants in both groups will be asked to complete a brief assessment at baseline, 6-months, 12-months, and 18-months. Participants in the experimental group will be asked to participate in the 12-session CSM program in addition to their regular SEE services.
Read the detailed description
The Coordinated Specialty Care (CSC) programs in the EPINET-TX Network provide Supported Employment and Education (SEE) services for young adults between the ages of 15-32 experiencing first episode psychosis (FEP). In this pilot cluster randomized clinical trial (RCT), six CSC programs representing different geographical regions including the urban southwest (serving a majority Latino population), the urban central and southeast (serving majority African American population), and the rural north and northeast (serving a racially/ethnically mixed population) that are part of the EPINET-TX Network will be recruited. Once the 6 SEE teams have been recruited, they will be randomized using a stratified procedure based on geographic region and populations served.
The 3 SEE teams randomized to the experimental group will be trained in CSM by the Boston University (BU) research team. During the training period, the CSC team program director and SEE specialist will be trained in CSM resources and methods, beginning with an online self-paced training course, followed by weekly and then biweekly zoom-based group supervision with BU researchers. CSM sessions will be audio-recorded as part of initial training and ongoing fidelity checks. Zoom meeting training sessions will also be recorded. CSM training is expected to take approximately three months, and the participating SEE programs will be reimbursed for staff training time. Designated site CSC personnel from both the experimental and the control group sites will be trained to administer the outcome assessments.
After training of CSC teams and assessors is complete, recruitment of young adults with FEP will begin at all 6 sites simultaneously. Recruitment of young adult participants will include information meetings conducted by the program directors of participating CSC programs, consent and assent meetings, and the baseline assessment. Once identified, these program directors will be added as staff on the Institutional Review Board (IRB).
The 6 CSC teams will then administer either the experimental intervention (CSM + SEE) intervention or the control intervention (SEE only). Staff within the experimental group will continue to receive support from the BU PI's, who will periodically administer the CSM Fidelity Scale to ensure CSM intervention fidelity.
Young adult participants in both the experimental and control groups will complete assessments at baseline, 6 months, 12 months, and 18 months. These assessments will take place in person by a trained onsite assessor. The baseline assessment battery will include a demographics questionnaire, history of employment and education questionnaire, the WRAT to assess reading level, and 2 cognitive assessments (described below). Follow-up assessments will only include the cognitive measures. These assessments are expected to take between 60-90 minutes for a total of 6 hours of time.
In addition, research sites will share the results of the Core Assessment Battery (CAB), an assessment that is administered as a part of routine CSC care every six months, with the BU researchers every 6 months. Additional information about prescribed medication, SEE program utilization, and psychiatric hospitalizations is normally collected quarterly and will be shared at each assessment. Education and employment logs will be collected weekly and shared with the BU research team. This information will be collected on all young adult participants.
Young adults with FEP in the experimental group will participate in the CSM intervention. The teaching of Cognitive Self-Management Strategies (CSM) by SEE specialists includes an additional 12 sessions that range from 45 to 60 minutes long. Thus, participants in the experimental group will complete about 18 hours of study activities over an 18-month period. Those in the control group will participate in the assessments, about 6 hours of study activities over an 18-month period.
After the study is over, participants from the control group still enrolled in the CSC program will be offered CSM if appropriate to their goals.
- Conditions
- First Episode Psychosis (FEP)
- Being tested
- Thinking Skills for Work-Cognitive Self-Management Program (CSM), Treatment as Usual (TAU)
- Keywords
- Young adults, First Episode Psychosis, Supported Employment and Education, Cognitive remediation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinking Skills for Work-Cognitive Self-Management Program (CSM)Behavioural
CSM is a 12-session program that promotes the development of specific cognitive strategies to promote success in employment and education outcomes. This is a standardized, evidence-based intervention with adults with serious mental illness. Each session is facilitated by a trained cognitive specialist and lasts between 45- 60 minutes. Session topics include self-assessment of cognitive skills, recognizing strengths, challenging negative thoughts, attention and concentration, memory, organization, planning, and thinking ahead.
Treatment as Usual (TAU)Behavioural
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
| Study group | Role | What they receive |
|---|---|---|
| CSM plus SEE Group | Experimental | The 3 sites (30 participants) from this site will receive the standardized 12 session CSM program in addition to regular SEE services. The CSM sessions will occur weekly and last between 45-60 minutes. They cover 12 different areas of cognition such as self-assessment, recognizing strengths, challenging negative thinking, attention and concentration, memory organization, planning ahead, problem-solving, and thinking speed. Receives: Behavioral: Thinking Skills for Work-Cognitive Self-Management Program (CSM); Behavioral: Treatment as Usual (TAU) |
| Treatment as Usual | Active comparator | In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
School and Education Activity Tracker
This qualitative measure tracks the participant's participation in education or employment activities on a weekly basis. It includes questions about the education or employment activity and the time spent completing the activity. The minimal value is 0, there is no maximum value.
Measured: Tracked weekly through study completion (about 18 months)
The Cognitive Problems and Strategies Assessment
Standardized measure that assesses cognitive functioning and strategy use. It includes two subscales, the "Cognitive Problems Subscale" and the "Strategy Use Subscale", each consisting of 30 items that are scored from 0-3 (cumulative 0-90). A higher score on the Cognitive Problems Subscale indicates a worse outcome, whereas higher scores on the Strategy Use Subscale indicate better outcomes.
Measured: Baseline, 6-, 12-, and 18-months
Cognitive Self-Efficacy Scale
Standardized measure that assesses an individual's confidence in everyday cognitive tasks. This is a 10 item scale with values ranging from 0 to 100, with higher values indicating better outcomes.
Measured: Baseline, 6-, 12-, and 18-months
Secondary outcomes (6)
The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
This 10-item clinician-rated instrument evaluates positive, negative, and affective symptom severity for individuals experiencing early-phase or first-episode psychotic disorders. Rated on a scale from 0 (not present) to 6 (very severe). Lower values indicate treatment progress in this study.
Measured: baseline, 6-, 12-,18-months
The Global Functioning Social and Role Subscales
This 2 item scale measure was designed for young adults and measures a participant's social connections and daily responsibilities. This clinician-rated scale is scored from 1 to 10, where higher numbers indicate better outcomes.
Measured: Baseline, 6-, 12-, 18-months
The Personal Wellbeing Index
This is a self-report, 8-item scale, that measures life satisfaction across standard of living, personal health, and relationships. Scores range from 0 (low-wellbeing) to 10 (high-wellbeing). Higher scores indicate better outcomes in this study.
Measured: Baseline, 6-, 12-, and 18- months
The Alcohol Use Scale
This study uses 1 item from this scale, "Please rate your worst 1 month over the past 6 months."
Participants report the following ratings:
- Abstinent
- Use with Impairment
- Mild Alcohol Use
- Moderate Alcohol Use
- Severe Alcohol Use Lower scores indicate better outcomes.
Measured: Baseline, 6-, 12-, and 18-months
The Drug Use Scale
This 1-item self-report scale measures a participant's drug use over the past 6 months. Participants report the following ratings:
- Abstinent
- Use with Impairment
- Mild Drug Use
- Moderate Drug Use
- Severe Drug Use Lower scores indicate better outcomes
Measured: Baseline, 6-, 12-, and 18-months
Substance Use Abuse Treatment Stage
This 1 item scale measures the extent to which a participant is engaged in treatment for their substance use. It is a self-report scale in which the participant chooses one of the following options:
- pre-engagement, no contact with substance use treatment services
- engagement, limited contact with substance use treatment services
- early persuasion, regular contact but no change in use
- late persuasion, regular contact with reductions in use
- early active treatment, regular contact, reductions in use for 1 month
- late active treatment, regular contact, reductions in use and working towards abstinence
- relapse prevention=regular contact, achieved abstinence for 6 months, occasional relapses
- remission/recovery, no problems with substance use Higher scores indicate better outcomes
Measured: Baseline, 6-, 12-, and 18-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start10 Aug 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for First Episode Psychosis (FEP)Studies 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
- This is a pilot cluster randomized controlled trial involving six research sites.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Susan R McGurk, PhD, Principal investigator, Boston University Center for Psychiatric RehabilitationKim Mueser, PhD, Principal investigator, Boston University Center for Psychiatric Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749105
- Sponsor's protocol ID
- 7734E
- Other IDs
- 90RTEM0004
- Status last verified
- Aug 2026
- First submitted
- 13 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share IPD from this trial
Publications
McGurk SR, Mueser KT, Xie H, Bloch P, DeTore NR, Pashka N, Guarino S, Ruiz A, Elliot C, Gagnon H, Bailey E, Fraser V, Welsh J, Cunningham H, Rizzano L, Wolfe R, Drake RE. A dismantling study of comprehensive cognitive remediation for improving employment outcomes: what is the role of computer cognitive training? Psychol Med. 2025 Jul 22;55:e208. doi: 10.1017/S0033291725100986.
PubMed 40692495McGurk, S. R., & Mueser, K. T. (2021). Cognitive Remediation for Successful Employment and Psychiatric Recovery: The Thinking Skills for Work Program. Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognitive and Work/School Outcomes in People With First Episode Psychosis: Testing the Effectiveness of Cognitive Self-Management Strategies
- ClinicalTrials.gov ID
- NCT07749105
- Acronym / sponsor ID
- 7734E
- Conditions
- First Episode Psychosis (FEP)
- Keywords
- Young adults, First Episode Psychosis, Supported Employment and Education, Cognitive remediation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Texas
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 6 Aug 2026 (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 pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young adults experiencing first episode psychosis. The main questions it aims to answer are:
- Does adding the CSM program to usual SEE services lead to improved work and school outcomes, such as ability to find a job or enroll in school, or ability to keep a job or stay in school?
- Does adding the CSM program to usual SEE services improve cognition and cognitive self-efficacy? Researchers will recruit six research sites and these will be randomized to either treatment as usual, where they will offer regular SEE services, or the experimental groups, where they will offer regular SEE services plus the CSM program.
Participants in both groups will be asked to complete a brief assessment at baseline, 6-months, 12-months, and 18-months. Participants in the experimental group will be asked to participate in the 12-session CSM program in addition to their regular SEE services.
Detailed description
The Coordinated Specialty Care (CSC) programs in the EPINET-TX Network provide Supported Employment and Education (SEE) services for young adults between the ages of 15-32 experiencing first episode psychosis (FEP). In this pilot cluster randomized clinical trial (RCT), six CSC programs representing different geographical regions including the urban southwest (serving a majority Latino population), the urban central and southeast (serving majority African American population), and the rural north and northeast (serving a racially/ethnically mixed population) that are part of the EPINET-TX Network will be recruited. Once the 6 SEE teams have been recruited, they will be randomized using a stratified procedure based on geographic region and populations served.
The 3 SEE teams randomized to the experimental group will be trained in CSM by the Boston University (BU) research team. During the training period, the CSC team program director and SEE specialist will be trained in CSM resources and methods, beginning with an online self-paced training course, followed by weekly and then biweekly zoom-based group supervision with BU researchers. CSM sessions will be audio-recorded as part of initial training and ongoing fidelity checks. Zoom meeting training sessions will also be recorded. CSM training is expected to take approximately three months, and the participating SEE programs will be reimbursed for staff training time. Designated site CSC personnel from both the experimental and the control group sites will be trained to administer the outcome assessments.
After training of CSC teams and assessors is complete, recruitment of young adults with FEP will begin at all 6 sites simultaneously. Recruitment of young adult participants will include information meetings conducted by the program directors of participating CSC programs, consent and assent meetings, and the baseline assessment. Once identified, these program directors will be added as staff on the Institutional Review Board (IRB).
The 6 CSC teams will then administer either the experimental intervention (CSM + SEE) intervention or the control intervention (SEE only). Staff within the experimental group will continue to receive support from the BU PI's, who will periodically administer the CSM Fidelity Scale to ensure CSM intervention fidelity.
Young adult participants in both the experimental and control groups will complete assessments at baseline, 6 months, 12 months, and 18 months. These assessments will take place in person by a trained onsite assessor. The baseline assessment battery will include a demographics questionnaire, history of employment and education questionnaire, the WRAT to assess reading level, and 2 cognitive assessments (described below). Follow-up assessments will only include the cognitive measures. These assessments are expected to take between 60-90 minutes for a total of 6 hours of time.
In addition, research sites will share the results of the Core Assessment Battery (CAB), an assessment that is administered as a part of routine CSC care every six months, with the BU researchers every 6 months. Additional information about prescribed medication, SEE program utilization, and psychiatric hospitalizations is normally collected quarterly and will be shared at each assessment. Education and employment logs will be collected weekly and shared with the BU research team. This information will be collected on all young adult participants.
Young adults with FEP in the experimental group will participate in the CSM intervention. The teaching of Cognitive Self-Management Strategies (CSM) by SEE specialists includes an additional 12 sessions that range from 45 to 60 minutes long. Thus, participants in the experimental group will complete about 18 hours of study activities over an 18-month period. Those in the control group will participate in the assessments, about 6 hours of study activities over an 18-month period.
After the study is over, participants from the control group still enrolled in the CSC program will be offered CSM if appropriate to their goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot cluster randomized controlled trial involving six research sites.
| Arm | Type | Receives |
|---|---|---|
| CSM plus SEE Group | Experimental | Behavioral: Thinking Skills for Work-Cognitive Self-Management Program (CSM), Behavioral: Treatment as Usual (TAU)The 3 sites (30 participants) from this site will receive the standardized 12 session CSM program in addition to regular SEE services. The CSM sessions will occur weekly and last between 45-60 minutes. They cover 12 different areas of cognition such as self-assessment, recognizing strengths, challenging negative thinking, attention and concentration, memory organization, planning ahead, problem-solving, and thinking speed. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as Usual (TAU)In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services. |
Who may qualify
- Ages
- 15 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- currently in their first 18 months of enrollment in the CSC program
- at least 15 years of age
- receiving SEE services but not employed or enrolled in school
- have the desire to work or resume school.
Key exclusion criteria (1 listed)
- 1) Young adults who are not fluent in english
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 |
|---|---|---|
| Thinking Skills for Work-Cognitive Self-Management Program (CSM)CSM is a 12-session program that promotes the development of specific cognitive strategies to promote success in employment and education outcomes. This is a standardized, evidence-based intervention with adults with serious mental illness. Each session is facilitated by a trained cognitive specialist and lasts between 45- 60 minutes. Session topics include self-assessment of cognitive skills, recognizing strengths, challenging negative thoughts, attention and concentration, memory, organization, planning, and thinking ahead. | Behavioural | CSM plus SEE Group |
| Treatment as Usual (TAU)In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services. | Behavioural | CSM plus SEE Group, Treatment as Usual |
Primary outcome
School and Education Activity Tracker
Time frame: Tracked weekly through study completion (about 18 months)
This qualitative measure tracks the participant's participation in education or employment activities on a weekly basis. It includes questions about the education or employment activity and the time spent completing the activity. The minimal value is 0, there is no maximum value.
The Cognitive Problems and Strategies Assessment
Time frame: Baseline, 6-, 12-, and 18-months
Standardized measure that assesses cognitive functioning and strategy use. It includes two subscales, the "Cognitive Problems Subscale" and the "Strategy Use Subscale", each consisting of 30 items that are scored from 0-3 (cumulative 0-90). A higher score on the Cognitive Problems Subscale indicates a worse outcome, whereas higher scores on the Strategy Use Subscale indicate better outcomes.
Cognitive Self-Efficacy Scale
Time frame: Baseline, 6-, 12-, and 18-months
Standardized measure that assesses an individual's confidence in everyday cognitive tasks. This is a 10 item scale with values ranging from 0 to 100, with higher values indicating better outcomes.
6 secondary outcomes
The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
Time frame: baseline, 6-, 12-,18-months
The Global Functioning Social and Role Subscales
Time frame: Baseline, 6-, 12-, 18-months
The Personal Wellbeing Index
Time frame: Baseline, 6-, 12-, and 18- months
The Alcohol Use Scale
Time frame: Baseline, 6-, 12-, and 18-months
The Drug Use Scale
Time frame: Baseline, 6-, 12-, and 18-months
Substance Use Abuse Treatment Stage
Time frame: Baseline, 6-, 12-, and 18-months
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 6 Aug 2026.
- Background: PubMed 40692495McGurk SR, Mueser KT, Xie H, Bloch P, DeTore NR, Pashka N, Guarino S, Ruiz A, Elliot C, Gagnon H, Bailey E, Fraser V, Welsh J, Cunningham H, Rizzano L, Wolfe R, Drake RE. A dismantling study of comprehensive cognitive remediation for improving employment outcomes: what is the role of computer cognitive training? Psychol Med. 2025 Jul 22;55:e208. doi: 10.1017/S0033291725100986.
- BackgroundMcGurk, S. R., & Mueser, K. T. (2021). Cognitive Remediation for Successful Employment and Psychiatric Recovery: The Thinking Skills for Work Program. Guilford Press.
- Individual participant dataSharing planned: No. There are no plans to share IPD from this trial
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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.
Susan R McGurk, PhD principal investigator
Boston University Center for Psychiatric Rehabilitation
Kim Mueser, PhD principal investigator
Boston University Center for Psychiatric Rehabilitation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thinking Skills for Work-Cognitive Self-Management Program (CSM) and Treatment as Usual (TAU) in people with First Episode Psychosis (FEP), run by Boston University Charles River Campus at 4 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
Contact Susan R McGurk, PhD (617-353-3549, mcgurk@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School and Education Activity Tracker (time frame: Tracked weekly through study completion (about 18 months)). 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 NCT07749105, which also lists 2 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 6 Aug 2026.