An interventional study of Building a Strong Identity and Coping Skills in Chronic Stress, Anxiety and Depression, sponsored by Penn State University. Recruiting at 5 sites in United States. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Penn State University · Not applicable, Interventional, and Treatment
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Among 3,709 studies in Depression with a site in United States — 578 open to participants now, 717 under way, 30 of them phase 3. Depression · United States.
Among the 3,709 studies in Depression with a site in United States, this one is the 452nd largest by planned enrollment of the 3,316 interventional ones that give a count, is one of 207 that started in 2025, is one of 2,215 with no phase, reaches primary completion later than 617 of the 715 other live ones, and was the 2,963rd registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →578 of the 3,709 studies in Depression with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 13–17
NeuroRx, Inc. · Sites in United States
Ages 18–80
Ohio State University · Sites in United States
Ages 21–65
Florida State University · Sites in United States
Ages 18–55 · Healthy volunteers
University of Texas Southwestern Medical Center · Sites in United States
Ages 12–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 11 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,709 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 235 · Phase 2 441 · Phase 3 285 · Phase 4 265
First in 1977; this study’s year is marked. 207 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 360 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 72 across the 3,316 interventional studies, 138 across the 371 observational. Of the 2,761 that completed or were terminated, 1,045 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
392 of 3,709 have an industry lead sponsor. The 10 most frequent:
Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
Penn State University has 8 studies filed under Depression — fewer than ten, so there is no comparison to draw.
299 of the studies in Depression with a site in United States that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT06922110Phase 3Xenon Pharmaceuticals Inc.An Open-Label Study of Azetukalner in Major Depressive Disorder | 2027-01 |
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT04777357Phase 3AbbVieA Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder. | 2027-03 |
| NCT07076407Phase 3Xenon Pharmaceuticals Inc.A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3) | 2027-05 |
Add all 299 to your calendar (.ics) → With an account.
Among the 3,709 studies in Depression with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services.
The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration.
Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
This study's planned enrollment of 360 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Browse Depression studies →Penn State University is the lead sponsor of 270 studies on the registry; 53 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.
Compared within Depression, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intervention = Building a String Identity and Coping Skills (BaSICS). Children randomized to participate in 16 twice weekly BaSICS intervention sessions. Children learn coping skills, identity development, and collective action as ways to buffer against chronic stress. These children also complete pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments.
Behavioral: Building a Strong Identity and Coping Skills
These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments. No intervention.
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Also known as: BaSICS
Anxiety
Changes in the number of anxiety problems that children report. Anxiety problems will be measured using the Screen for Child Anxiety Related Disorders (SCARED), Child Behavior Checklist (CBCL), and Youth Self Report (YSR).
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Depression
Changes in the number of depressive symptoms that children report. Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9A), CBCL, and YSR.
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Suicide Risk Markers
Changes in the number of suicide risk markers that children report. Suicide risk markers will be measured using the Child Trauma Screen (CTS) and Mini Kid.
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Engagement Coping Skills Acquisition
Changes in the number of coping skills that children can report. Engagement Coping Skills Acquisition will be assessed with the Responses to Stress Questionnaire (RSQ), Children's Sadness Management Scale (CSMS) and Coping Skills Scale (CSS).
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90-minute Trier Social Stress Test (TSST) protocol
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Collaborative Coping
Changes in the number of collaborative coping skills that children report. Collaborative Coping will be assessed with the Collaborative Coping Discussion, Youth Civic and Character Measure (YCCM), and Social Skills Improvement System (SSIS).
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Sociocultural Identity Development
Changes in the sociocultural identity beliefs that children report. Sociocultural identity beliefs will be assessed with the Child and Adolescent Social Support (CASS), Early Identity Exploration Scale (EIES), and Multigroup Ethnic Identity Measure (MEIM).
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Plan to share: Yes — All data produced in the course of the project will be preserved and shared after de-identification. Item level spreadsheet data for all variables will be shared openly once cleaned. Data will be deposited into the National Institute of Mental Health Data Archive.
Time frame: Data will become available after de-identification and cleaning.
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for May 2029, 51 months after the start.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 51 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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