search
Back to results

Preventing Internalizing in Preadolescents Exposed to Chronic Stress

Primary Purpose

Chronic Stress, Anxiety, Depression

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building a Strong Identity and Coping Skills
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Stress focused on measuring poverty, discrimination

Eligibility Criteria

11 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Child age 11 or 12 at intake
  • Family income at or below 200% Federal Poverty Level
  • Child speaks English
  • Parent speaks English or Spanish

Exclusion Criteria:

  • Intellectual disability
  • Autism diagnosis
  • Exceeds clinical cutoff for anxiety or depressive disorder

Sites / Locations

  • Hamilton Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BaSICS Intervention

Comparison

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

HPA Reactivity Profile
Changes in levels of salivary cortisol across a 90 minute Trier Social Stress Test protocol

Secondary Outcome Measures

Internalizing symptoms
Reductions in total internalizing symptoms reported by parents on the CHild Behavior Checklist
Coping Skills Acquisition
Changes in the number of coping skills that children can report during the Coping Skills interview protocol.

Full Information

First Posted
April 26, 2016
Last Updated
September 27, 2023
Sponsor
Penn State University
search

1. Study Identification

Unique Protocol Identification Number
NCT02764138
Brief Title
Preventing Internalizing in Preadolescents Exposed to Chronic Stress
Official Title
Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stress, Anxiety, Depression
Keywords
poverty, discrimination

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BaSICS Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparison
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Building a Strong Identity and Coping Skills
Other Intervention Name(s)
BaSICS
Intervention Description
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action.
Primary Outcome Measure Information:
Title
HPA Reactivity Profile
Description
Changes in levels of salivary cortisol across a 90 minute Trier Social Stress Test protocol
Time Frame
Pre-post (3 months) and Pre-follow-up (6 and 12 months)
Secondary Outcome Measure Information:
Title
Internalizing symptoms
Description
Reductions in total internalizing symptoms reported by parents on the CHild Behavior Checklist
Time Frame
Pre-follow-up (6 and 12 months)
Title
Coping Skills Acquisition
Description
Changes in the number of coping skills that children can report during the Coping Skills interview protocol.
Time Frame
pre-post (3 months) and Pre-follow-up (6 and 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Child age 11 or 12 at intake Family income at or below 200% Federal Poverty Level Child speaks English Parent speaks English or Spanish Exclusion Criteria: Intellectual disability Autism diagnosis Exceeds clinical cutoff for anxiety or depressive disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha E Wadsworth, Ph.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
National Data Archives

Learn more about this trial

Preventing Internalizing in Preadolescents Exposed to Chronic Stress

We'll reach out to this number within 24 hrs