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Preventing Internalizing in Preadolescents Exposed to Chronic Stress

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ClinicalTrials.gov Identifier: NCT02764138
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Martha E. Wadsworth, Penn State University

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.

Condition or disease Intervention/treatment Phase
Chronic Stress Anxiety Depression Behavioral: Building a Strong Identity and Coping Skills Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
Study Start Date : April 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BaSICS Intervention

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.

Behavioral: Building a Strong Identity and Coping Skills
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action.
Other Name: BaSICS

No Intervention: Comparison
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Internalizing symptoms [ Time Frame: Pre-follow-up (6 and 12 months) ]
    Reductions in total internalizing symptoms reported by parents on the CHild Behavior Checklist

  2. Coping Skills Acquisition [ Time Frame: pre-post (3 months) and Pre-follow-up (6 and 12 months) ]
    Changes in the number of coping skills that children can report during the Coping Skills interview protocol.



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Ages Eligible for Study:   11 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764138


Contacts
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Contact: Martha E Wadsworth, Ph.D. 814-865-2878 mew27@psu.edu
Contact: Jarl A Ahlkvist, Ph.D. 720-220-7736 jua22@psu.edu

Locations
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United States, Pennsylvania
Hamilton Health Center Recruiting
Harrisburg, Pennsylvania, United States, 17104
Contact: Brad Gebhart, MA    717-232-9971    bgebhart@hamiltonhealthcenter.com   
Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Martha E Wadsworth, Ph.D. Penn State University
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Responsible Party: Martha E. Wadsworth, Associate Professor, Penn State University
ClinicalTrials.gov Identifier: NCT02764138    
Other Study ID Numbers: R33MH107631 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: National Data Archives
Keywords provided by Martha E. Wadsworth, Penn State University:
poverty
discrimination
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms