Chronic StressNCT05789446
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
A study testing Building a Strong Identity and Coping Skills in people with Chronic Stress and Anxiety, run by Penn State University at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress, Anxiety, Depression
- What is being tested?
- Building a Strong Identity and Coping Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2025to 31 May 2030
- 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 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children ages 11-14 at intake
- Family income at or below 200% federal poverty level
- Child speaks English
- Parent speaks English or Spanish
Who cannot join
- Intellectual disability
- Autism spectrum disorder
- High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
- Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dara Babinksi, PhD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
Pennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, 17110
Jasmin Lagman, MD, jlagman@pennstatehealth.psu.edu
- Recruiting
Penn State Health Medical Group - Psychiatry and Behavioral Health
Hershey, Pennsylvania, 17033
Dara Babinski, PhD, dbabinski@pennstatehealth.psu.edu
Dara Babinski, Ph.D.
- Not yet recruiting
Penns Valley Area School District
Spring Mills, Pennsylvania, 16875
Kurt Nyquist, knyquist@pennsvalley.org
- Recruiting
Dr. Edwin L. Herr Clinic
State College, Pennsylvania, 16802
Kristen Nadermann, PhD, kmc452@psu.edu
Martha Wadsworth, Ph.D.
- Recruiting
Penn State Psychological Clinic
State College, Pennsylvania, 16802
Estee Hausman, PhD, exh471@psu.edu
Martha Wadsworth, Ph.D.
About this study
Official title: Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
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
- Conditions
- Chronic Stress, Anxiety, Depression
- Being tested
- Building a Strong Identity and Coping Skills
- Keywords
- Poverty, Discrimination, Stress, Coping
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building a Strong Identity and Coping SkillsBehavioural
Also called BaSICS
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
| Study group | Role | What they receive |
|---|---|---|
| BaSICS Intervention | Experimental | 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. Receives: Behavioral: Building a Strong Identity and Coping Skills |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Secondary outcomes (4)
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).
Measured: 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
Measured: 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).
Measured: 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).
Measured: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Feb 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StressStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha E. Wadsworth, Penn State University
- Investigators
- Martha E Wadsworth, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789446
- Sponsor's protocol ID
- PAR-21-132
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
- ClinicalTrials.gov ID
- NCT05789446
- Acronym / sponsor ID
- PAR-21-132
- Conditions
- Chronic Stress, Anxiety, Depression
- Keywords
- Poverty, Discrimination, Stress, Coping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 29 Mar 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BaSICS Intervention | Experimental | Behavioral: Building a Strong Identity and Coping SkillsIntervention = 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children ages 11-14 at intake
- Family income at or below 200% federal poverty level
- Child speaks English
- Parent speaks English or Spanish
Key exclusion criteria (4 listed)
- Intellectual disability
- Autism spectrum disorder
- High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))
- Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
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 |
|---|---|---|
| Building a Strong Identity and Coping SkillsAlso: BaSICSPsychoeducational program to teach children coping skills, healthy identity development, and collective social action | Behavioural | BaSICS Intervention |
Primary outcome
Anxiety
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
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).
Depression
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
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.
Suicide Risk Markers
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
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.
4 secondary outcomes
Engagement Coping Skills Acquisition
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
HPA Reactivity Profile
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Collaborative Coping
Time frame: Pre-post (3 months) and Pre-follow up (6 and 12 months)
Sociocultural Identity Development
Time frame: Pre-post (3 months) and Pre-follow up (6 and 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 17 Sep 2026.
- Individual participant dataSharing planned: 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.
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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.
Dara Babinksi, PhD contact
Martha E Wadsworth, PhD principal investigator
Penn State University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building a Strong Identity and Coping Skills in people with Chronic Stress and Anxiety, run by Penn State University at 5 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 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Martha E Wadsworth, PhD (814-865-2878, mew27@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Pre-post (3 months) and Pre-follow up (6 and 12 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?
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 17 Sep 2026.