Obsessive Compulsive Disorder (OCD)IMPACT-RINCT06934525
Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.
A study testing Team-delivered, exposure-based CBT in people with Obsessive Compulsive Disorder (OCD) and Pediatric Anxiety Disorders, run by Bradley Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders, Anxiety Disorder
- What is being tested?
- Team-delivered, exposure-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Aug 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 5-18 inclusive
- Primary or co-primary DSM-V diagnosis of anxiety or OCD
- Symptom duration of at least 3 months
- Outpatient care needed
- Presence of a stable parent, or guardian, who can participate in treatment
Who cannot join
- Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
- Acute suicidality
- Concurrent psychotherapy
- Chronic medical illness that would preclude their active participation in treatment
- Treatment with psychotropic medication that is not stable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bradley Hospital
East Providence, Rhode Island, 02915
Jennifer Freeman, PhD, 4014321057, jfreeman@brownhealth.org
About this study
Official title: Testing Delivery Modalities of Team-Based Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety in Community Health Settings: Developing Pathways to Health Equity
The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.
Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.
The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.
Read the detailed description
Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Youth from historically marginalized groups face even greater barriers to accessing high-quality care, including limited availability and inconvenience of services, transportation difficulties, lower mental health literacy, and experiences of stigmatization and discrimination. Systematic reviews consistently show comparable outcomes for in-person vs. telehealth treatment for anxiety yet results highlight the lack of rigorous comparative research in understanding which patient subgroups are more likely to benefit from different delivery modalities, making the process of selecting among them more confusing than ever for families. In the wake of the COVID-19 pandemic, using a flexible service modality (i.e., custom mix of telehealth and in-person sessions) has also become common practice. The question of how best to improve access to high quality care is particularly relevant in community health settings (e.g., Certified Community Behavioral Health Centers (CCBHCs) and Federally Qualified Health Centers (FQHCs)) that serve a high proportion of vulnerable youth due to the staggering and longstanding failure to include these youth in clinical trials and the clear need to tailor treatment to better address barriers to access, quality, and clinical improvement. The overall goal of this proposal is to compare three modalities for delivering outpatient exposure-based CBT in youth ages 5-18 using existing care teams in CCBHC/FQHC ("safety net") settings: in-person (traditional face-to-face sessions only, occurring in the office and home/community) vs. telehealth (only occurring remotely via web-based video conference) vs. flexible (tailored mix of telehealth and/or in-person sessions). A total of 501 children with anxiety and/or OCD will be treated, with 167 children randomly assigned to each of the treatment conditions. A trained independent evaluator (IE) masked to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 8, 16, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of in-person vs. telehealth vs. flexible CBT for: reducing anxiety-related functional impairment, improving family treatment engagement, improving family satisfaction, reducing barriers to treatment access, and maintaining treatment quality. Secondary outcomes are to understand predictors of pre- to post-treatment change in functional impairment including severity of illness, caregiver burden, and family accommodation and to explore group differences in time course of response and durability of treatment gains. Longer-term goals include establishing a service delivery model that can be scaled nationally in similar practice settings. Primary outcomes are driven by real world needs of patients and families and selected in collaboration with stakeholders. The approach for all aims will involve regression of the outcome variable on treatment group (flexible vs in-person or telehealth), randomization stratification factors (minoritized race/ethnicity, site), a small number of pre-specified covariates that are hypothesized to be strongly associated with the outcome (age, poverty), and baseline value of the outcome, as appropriate. This is the ANCOVA approach to analysis in randomized controlled trials. Missing data will be handled with multiple imputation using chained equations. In secondary analyses, we will evaluate the potential impact of missing data and assumptions regarding the relationship of missing data mechanisms and treatment effect estimates using sensitivity analyses.
- Conditions
- Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders, Anxiety Disorder, Anxiety, OCD, Phobia
- Being tested
- Team-delivered, exposure-based CBT
- Keywords
- exposure therapy, cognitive behavioral therapy, anxiety treatment, exposure and response prevention therapy, ERP, pediatric anxiety treatment
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders, Phobic Disorders, Agoraphobia, Generalized Anxiety Disorder, Mutism, Anxiety, Separation, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-delivered, exposure-based CBTBehavioural
Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Flexible | Other | Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis. Receives: Behavioral: Team-delivered, exposure-based CBT |
| In-person | Other | Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office. Receives: Behavioral: Team-delivered, exposure-based CBT |
| Telehealth | Other | Families will only attend sessions via a secure remote video platform. Receives: Behavioral: Team-delivered, exposure-based CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Top Problems Assessment- Caregiver report
The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Child Sheehan Disability Scale (CSDS)- caregiver report
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Secondary outcomes (10)
Client Satisfaction Questionnaire-Revised (CSQ-8-R)
The CSQ-8-R measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.
Measured: Week 8, Week 16 and follow-up (6 & 12 months)
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Clinical Global Impression Scales
The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Exposure Guide
The Exposure Guide is an empirically-supported exposure therapy fidelity/quality tool completed by study therapists. It measures exposure quality, including: therapist use of specific strategies that predict clinical improvement, exposure completion, exposure difficulty, therapeutic learning, barriers to completion, and engagement.
Measured: Weekly at Week 1 through 24.
Caregiver Strain Questionnaire (CSQ)
The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Reasons for Treatment Discontinuation form
This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.
Measured: Administered only at discharge, up to 6-months into study
End of Treatment Form
This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.
Measured: Administered only at discharge, up to 6-months into study
Homework Compliance
Providers will rate the quality and quantity of homework between sessions
Measured: Every session- up to 24 weeks of acute treatment
Youth Top Problems Assessment
The TPA is designed to independently solicit from youth the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Youth Child Sheehan Disability Scale (CSDS)
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
Measured: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Nov 2025
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 501 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934525
- Sponsor's protocol ID
- BPS2023C233953
- Acronym
- IMPACT-RI
- Status last verified
- May 2026
- First submitted
- 3 Apr 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Delivery Modalities of Team-Based Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety in Community Health Settings: Developing Pathways to Health Equity
- ClinicalTrials.gov ID
- NCT06934525
- Acronym / sponsor ID
- IMPACT-RI / BPS2023C233953
- Conditions
- Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders, Anxiety Disorder, Anxiety, OCD, Phobia
- Keywords
- exposure therapy, cognitive behavioral therapy, anxiety treatment, exposure and response prevention therapy, ERP, pediatric anxiety treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 501 participants (estimated)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 18 Apr 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 purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.
Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.
The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.
Detailed description
Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Youth from historically marginalized groups face even greater barriers to accessing high-quality care, including limited availability and inconvenience of services, transportation difficulties, lower mental health literacy, and experiences of stigmatization and discrimination. Systematic reviews consistently show comparable outcomes for in-person vs. telehealth treatment for anxiety yet results highlight the lack of rigorous comparative research in understanding which patient subgroups are more likely to benefit from different delivery modalities, making the process of selecting among them more confusing than ever for families. In the wake of the COVID-19 pandemic, using a flexible service modality (i.e., custom mix of telehealth and in-person sessions) has also become common practice. The question of how best to improve access to high quality care is particularly relevant in community health settings (e.g., Certified Community Behavioral Health Centers (CCBHCs) and Federally Qualified Health Centers (FQHCs)) that serve a high proportion of vulnerable youth due to the staggering and longstanding failure to include these youth in clinical trials and the clear need to tailor treatment to better address barriers to access, quality, and clinical improvement. The overall goal of this proposal is to compare three modalities for delivering outpatient exposure-based CBT in youth ages 5-18 using existing care teams in CCBHC/FQHC ("safety net") settings: in-person (traditional face-to-face sessions only, occurring in the office and home/community) vs. telehealth (only occurring remotely via web-based video conference) vs. flexible (tailored mix of telehealth and/or in-person sessions). A total of 501 children with anxiety and/or OCD will be treated, with 167 children randomly assigned to each of the treatment conditions. A trained independent evaluator (IE) masked to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 8, 16, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of in-person vs. telehealth vs. flexible CBT for: reducing anxiety-related functional impairment, improving family treatment engagement, improving family satisfaction, reducing barriers to treatment access, and maintaining treatment quality. Secondary outcomes are to understand predictors of pre- to post-treatment change in functional impairment including severity of illness, caregiver burden, and family accommodation and to explore group differences in time course of response and durability of treatment gains. Longer-term goals include establishing a service delivery model that can be scaled nationally in similar practice settings. Primary outcomes are driven by real world needs of patients and families and selected in collaboration with stakeholders. The approach for all aims will involve regression of the outcome variable on treatment group (flexible vs in-person or telehealth), randomization stratification factors (minoritized race/ethnicity, site), a small number of pre-specified covariates that are hypothesized to be strongly associated with the outcome (age, poverty), and baseline value of the outcome, as appropriate. This is the ANCOVA approach to analysis in randomized controlled trials. Missing data will be handled with multiple imputation using chained equations. In secondary analyses, we will evaluate the potential impact of missing data and assumptions regarding the relationship of missing data mechanisms and treatment effect estimates using sensitivity analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexible | Other | Behavioral: Team-delivered, exposure-based CBTFamilies and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis. |
| In-person | Other | Behavioral: Team-delivered, exposure-based CBTFamilies will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office. |
| Telehealth | Other | Behavioral: Team-delivered, exposure-based CBTFamilies will only attend sessions via a secure remote video platform. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 5-18 inclusive
- Primary or co-primary DSM-V diagnosis of anxiety or OCD
- Symptom duration of at least 3 months
- Outpatient care needed
- Presence of a stable parent, or guardian, who can participate in treatment
Key exclusion criteria (5 listed)
- Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
- Acute suicidality
- Concurrent psychotherapy
- Chronic medical illness that would preclude their active participation in treatment
- Treatment with psychotropic medication that is not stable
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 |
|---|---|---|
| Team-delivered, exposure-based CBTPatient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy | Behavioural | Flexible, In-person, Telehealth |
Primary outcome
Top Problems Assessment- Caregiver report
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).
Child Sheehan Disability Scale (CSDS)- caregiver report
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.
10 secondary outcomes
Client Satisfaction Questionnaire-Revised (CSQ-8-R)
Time frame: Week 8, Week 16 and follow-up (6 & 12 months)
Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Clinical Global Impression Scales
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Exposure Guide
Time frame: Weekly at Week 1 through 24.
Caregiver Strain Questionnaire (CSQ)
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Reasons for Treatment Discontinuation form
Time frame: Administered only at discharge, up to 6-months into study
End of Treatment Form
Time frame: Administered only at discharge, up to 6-months into study
Homework Compliance
Time frame: Every session- up to 24 weeks of acute treatment
Youth Top Problems Assessment
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Youth Child Sheehan Disability Scale (CSDS)
Time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 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 31 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-delivered, exposure-based CBT in people with Obsessive Compulsive Disorder (OCD) and Pediatric Anxiety Disorders, run by Bradley Hospital 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 5 inclusion and 5 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 31 Jul 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?
Contact Jennifer Freeman, PhD (401-432-1000, jfreeman@brownhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Top Problems Assessment- Caregiver report (time frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.