Clinical trial NCT02764138: Preventing Internalizing in Preadolescents Exposed to Chronic Stress
Official title: Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stress
Anxiety
Depression
Keywords: poverty
discrimination
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 105
Sex: ALL
Minimum age (years): 11
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: HPA Reactivity Profile
timeFrame: Pre-post (3 months) and Pre-follow-up (6 and 12 months)
Secondary outcomes:
measure: Internalizing symptoms
timeFrame: Pre-follow-up (6 and 12 months)
measure: Coping Skills Acquisition
timeFrame: pre-post (3 months) and Pre-follow-up (6 and 12 months)
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Hamilton Health Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Martha E Wadsworth, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: