Anxiety DisordersNCT05962879
Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
A study testing Resilience Training for Teens in people with Anxiety Disorders and Psychotic Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Anxiety Disorders, Psychotic Disorders, Depressive Disorder
- What is being tested?
- Resilience Training for Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 31 May 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Currently enrolled in 9th through 12th grade and between the ages of 14 and 19
- Endorsed at least one psychotic experience
- Provided contact information
- Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)
- Have a parent or legal guardian who is able and willing to participate in a parent session
- Competent and willing to provide written informed assent (if under the age of 18) or consent (if age 18 or older)
- Able to communicate in English
Who cannot join
- Currently prescribed psychotropic medication (not including medications for attention deficit/hyperactivity disorder), regardless of adherence
- Currently obtaining psychotherapeutic intervention
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Nicole R DeTore, PhD, ndetore@mgh.harvard.edu
About this study
This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.
- Being tested
- Resilience Training for Teens
- Medical subject headings
- Anxiety Disorders, Psychotic Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience Training for TeensBehavioural
A brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Training for Teens | Experimental | A brief 6-session group-based behavioral intervention for teens at risk of a mental illness. Receives: Behavioral: Resilience Training for Teens |
| Waitlist | No intervention | A one year waitlist period where participants will not participate in Resilience Training for Teens. Following that one year waitlist period, they can participate in Resilience Training for Teens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interview of Psychosis-risk Syndromes (SIPS)
Subclinical psychotic symptoms that represent a risk of transdiagnostic mental illnesses. This semi-structured interview rates psychotic experiences, general symptoms, and functioning. The SIPS interview assesses positive, negative, disorganized, and general symptoms. The range of the Scale of Psychosis-risk Symptoms (SOPS) is 0-6, with a higher score representing more severe symptoms.
Measured: 1 year
Secondary outcomes (2)
Child Behavior Checklist (CBCL)
Mental health symptoms in the teen rated by both the teen and the parent/guardian consisting of 113 items. The CBCL rates multiple domains across functioning and psychiatric diagnoses. It is scored on a 3-point Likert scale, with higher scores representing more severe symptoms.
Measured: 1 year
Global Functioning Social and Role Scales
Social and school/work functioning captured on this scale rated on a 10 point likert scale assessing functional and social functioning separately. Higher ratings represent richer functioning.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start22 Mar 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nicole DeTore, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962879
- Sponsor's protocol ID
- 2023P000985
- Other IDs
- K23MH131793
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Transdiagnostic Intervention for Adolescents at Risk for Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05962879
- Acronym / sponsor ID
- 2023P000985
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Jul 2023 (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.
This research study aims to develop a brief group-based treatment called Resilience Training for Teens, then to test how well it protects high school students with mild symptoms of depression, anxiety, or having unusual feelings from developing mental illnesses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience Training for Teens | Experimental | Behavioral: Resilience Training for TeensA brief 6-session group-based behavioral intervention for teens at risk of a mental illness. |
| Waitlist | No intervention | –A one year waitlist period where participants will not participate in Resilience Training for Teens. Following that one year waitlist period, they can participate in Resilience Training for Teens. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Currently enrolled in 9th through 12th grade and between the ages of 14 and 19
- Endorsed at least one psychotic experience
- Provided contact information
- Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18)
- Have a parent or legal guardian who is able and willing to participate in a parent session
Key exclusion criteria (2 listed)
- Currently prescribed psychotropic medication (not including medications for attention deficit/hyperactivity disorder), regardless of adherence
- Currently obtaining psychotherapeutic 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 |
|---|---|---|
| Resilience Training for TeensA brief 6-session group-based behavioral intervention for high school aged teenagers at risk of a mental illness. | Behavioural | Resilience Training for Teens |
Primary outcome
Structured Interview of Psychosis-risk Syndromes (SIPS)
Time frame: 1 year
Subclinical psychotic symptoms that represent a risk of transdiagnostic mental illnesses. This semi-structured interview rates psychotic experiences, general symptoms, and functioning. The SIPS interview assesses positive, negative, disorganized, and general symptoms. The range of the Scale of Psychosis-risk Symptoms (SOPS) is 0-6, with a higher score representing more severe symptoms.
2 secondary outcomes
Child Behavior Checklist (CBCL)
Time frame: 1 year
Global Functioning Social and Role Scales
Time frame: 1 year
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 11 Jun 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 Resilience Training for Teens in people with Anxiety Disorders and Psychotic Disorders, run by Massachusetts General 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 7 inclusion and 2 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 11 Jun 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 Nicole R DeTore, PhD (617-726-2065, ndetore@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview of Psychosis-risk Syndromes (SIPS) (time frame: 1 year). 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 11 Jun 2026.