Chronic StressNCT02764138
Preventing Internalizing in Preadolescents Exposed to Chronic Stress
A study testing Building a Strong Identity and Coping Skills in people with Chronic Stress and Anxiety, run by Penn State University at 1 site in United States.
Trial summary
Racial and socioeconomic disparities in physical and mental health problems are large, persistent, and severe; begin during childhood; and stem from in part damage to physiologic stress response systems caused by chronic stress. Read more about this study
- Who is it for?
- Ages 11 to 12 yearsHealthy 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
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child age 11 or 12 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 diagnosis
- Exceeds clinical cutoff for anxiety or depressive disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Hamilton Health Center
Harrisburg, Pennsylvania, 17104
About this study
Official title: Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
Racial and socioeconomic disparities in physical and mental health problems are large, persistent, and severe; begin during childhood; and stem from in part damage to physiologic stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt this progression of damage to a child's stress response system may offer new directions for combatting health disparities. This project will evaluate the efficacy of a new prevention program designed to teach preadolescent children effective ways for coping with chronic stress that will have direct effects on their physiologic stress response systems (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression, and post-traumatic stress symptoms and disorders.
Read the detailed description
Mental health problems disproportionately affect racial and ethnic minority populations, as well as populations that face chronic economic hardship. There is clear evidence that (1) the processes that lay the groundwork for mental health disparities is laid during childhood and (2) that damage to and dysregulation of the physiologic stress response is a powerful mechanism of the effects of chronic stress such as that associated with poverty on psychopathology. To contribute solutions to mental health disparities, interventions need to be capable of affecting the systems that confer the risk. Since the psychobiologic stress response system (e.g., hypothalamic-pituitary-adrenal axis; HPA) is a central mechanism linking health disparities to chronic stress, the stress response is a critical system to target. Improving children's ability to cope with stress and regulate their reactivity has the potential to break the cycle of damage, especially if the coping strategies and regulatory processes that we target have effects at the physiologic level. New evidence has emerged showing that different types of coping are evident at the level of the HPA-it is, therefore, time to evaluate whether a coping intervention designed for children facing chronic stress will both (a) improve children's ability to use primary and secondary control coping, and (b) have sustained effects at the physiologic level. The BaSICS intervention is designed to address core underlying mechanisms of risk and repair in the highly stressful context of poor, urban youths' lives.
Preadolescence is a crucial time during which children's ability to recognize stress and its causes matures, and repertoires for coping with stress grow in both size and complexity. In addition, preadolescence is a time of increased brain changes and growth in key self-regulatory organs and systems. Preadolescents are, therefore, at a ripe stage to benefit from coping-based prevention and the plasticity of this developmental period suggests that such changes have the potential to be long-lasting. BaSICS is designed to prevent the onset of anxiety, depression, and post-traumatic stress symptoms in preadolescent children facing chronic stress. Two mechanisms of action are targeted in this project. First, the project seeks to demonstrate that children facing chronic stress stemming from poverty, discrimination, and violence exposure can acquire and utilize new ways of coping that are adaptive in a wide variety of circumstances. Second, the project will examine the extent to which improved coping resulting from the intervention engages the physiologic intermediate mechanism of the HPA. Finally, the project aims to link changes in coping and the HPA to changes in internalizing symptoms that would signal prevention of the emergence of new or worsening of existing symptoms. Discovery of ways to prevent and/or halt this progression of damage to a child's stress response system that leads to psychopathology can offer new directions for combatting health disparities.
- Conditions
- Chronic Stress, Anxiety, Depression
- Being tested
- Building a Strong Identity and Coping Skills
- Keywords
- poverty, discrimination
- 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 3-month and 12-month follow-up assessments. Receives: Behavioral: Building a Strong Identity and Coping Skills |
| Comparison | No intervention | These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 3-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.
HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90 minute Trier Social Stress Test protocol
Measured: Pre-post (3 months) and Pre-follow-up (6 and 12 months)
Secondary outcomes (2)
Internalizing symptoms
Reductions in total internalizing symptoms reported by parents on the CHild Behavior Checklist
Measured: Pre-follow-up (6 and 12 months)
Coping Skills Acquisition
Changes in the number of coping skills that children can report during the Coping Skills interview protocol.
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 posted6 May 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2025
- Study completionJan 2025
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
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, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764138
- Sponsor's protocol ID
- R33MH107631
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2016
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: National Data Archives
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
- ClinicalTrials.gov ID
- NCT02764138
- Acronym / sponsor ID
- R33MH107631
- Conditions
- Chronic Stress, Anxiety, Depression
- Keywords
- poverty, discrimination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
Racial and socioeconomic disparities in physical and mental health problems are large, persistent, and severe; begin during childhood; and stem from in part damage to physiologic stress response systems caused by chronic stress. Discovery of ways to prevent and/or halt this progression of damage to a child's stress response system may offer new directions for combatting health disparities. This project will evaluate the efficacy of a new prevention program designed to teach preadolescent children effective ways for coping with chronic stress that will have direct effects on their physiologic stress response systems (hypothalamic-pituitary-adrenal axis) and ultimately prevent onset of anxiety, depression, and post-traumatic stress symptoms and disorders.
Detailed description
Mental health problems disproportionately affect racial and ethnic minority populations, as well as populations that face chronic economic hardship. There is clear evidence that (1) the processes that lay the groundwork for mental health disparities is laid during childhood and (2) that damage to and dysregulation of the physiologic stress response is a powerful mechanism of the effects of chronic stress such as that associated with poverty on psychopathology. To contribute solutions to mental health disparities, interventions need to be capable of affecting the systems that confer the risk. Since the psychobiologic stress response system (e.g., hypothalamic-pituitary-adrenal axis; HPA) is a central mechanism linking health disparities to chronic stress, the stress response is a critical system to target. Improving children's ability to cope with stress and regulate their reactivity has the potential to break the cycle of damage, especially if the coping strategies and regulatory processes that we target have effects at the physiologic level. New evidence has emerged showing that different types of coping are evident at the level of the HPA-it is, therefore, time to evaluate whether a coping intervention designed for children facing chronic stress will both (a) improve children's ability to use primary and secondary control coping, and (b) have sustained effects at the physiologic level. The BaSICS intervention is designed to address core underlying mechanisms of risk and repair in the highly stressful context of poor, urban youths' lives.
Preadolescence is a crucial time during which children's ability to recognize stress and its causes matures, and repertoires for coping with stress grow in both size and complexity. In addition, preadolescence is a time of increased brain changes and growth in key self-regulatory organs and systems. Preadolescents are, therefore, at a ripe stage to benefit from coping-based prevention and the plasticity of this developmental period suggests that such changes have the potential to be long-lasting. BaSICS is designed to prevent the onset of anxiety, depression, and post-traumatic stress symptoms in preadolescent children facing chronic stress. Two mechanisms of action are targeted in this project. First, the project seeks to demonstrate that children facing chronic stress stemming from poverty, discrimination, and violence exposure can acquire and utilize new ways of coping that are adaptive in a wide variety of circumstances. Second, the project will examine the extent to which improved coping resulting from the intervention engages the physiologic intermediate mechanism of the HPA. Finally, the project aims to link changes in coping and the HPA to changes in internalizing symptoms that would signal prevention of the emergence of new or worsening of existing symptoms. Discovery of ways to prevent and/or halt this progression of damage to a child's stress response system that leads to psychopathology can offer new directions for combatting health disparities.
Study design
- Primary purpose
- Prevention
- 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 3-month and 12-month follow-up assessments. |
| Comparison | No intervention | –These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 3-month and 12-month follow-up assessments. No intervention. |
Who may qualify
- Ages
- 11 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child age 11 or 12 at intake
- Family income at or below 200% Federal Poverty Level
- Child speaks English
- Parent speaks English or Spanish
Key exclusion criteria (3 listed)
- Intellectual disability
- Autism diagnosis
- Exceeds clinical cutoff for anxiety or depressive disorder
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
HPA Reactivity Profile
Time frame: Pre-post (3 months) and Pre-follow-up (6 and 12 months)
Changes in levels of salivary cortisol across a 90 minute Trier Social Stress Test protocol
2 secondary outcomes
Internalizing symptoms
Time frame: Pre-follow-up (6 and 12 months)
Coping Skills Acquisition
Time frame: pre-post (3 months) and Pre-follow-up (6 and 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes. National Data Archives
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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. This study is not recruiting at the moment.
Martha E Wadsworth, Ph.D. principal investigator
Penn State University
1 site 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 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPA Reactivity Profile (time frame: Pre-post (3 months) and Pre-follow-up (6 and 12 months)). 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 24 Jan 2025.