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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Stress Anxiety Depression||Behavioral: Building a Strong Identity and Coping Skills||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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
- Internalizing symptoms [ Time Frame: Pre-follow-up (6 and 12 months) ]Reductions in total internalizing symptoms reported by parents on the CHild Behavior Checklist
- 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.
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
|Contact: Martha E Wadsworth, Ph.D.||email@example.com|
|Contact: Jarl A Ahlkvist, Ph.D.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Hamilton Health Center||Recruiting|
|Harrisburg, Pennsylvania, United States, 17104|
|Contact: Brad Gebhart, MA 717-232-9971 email@example.com|
|Principal Investigator:||Martha E Wadsworth, Ph.D.||Penn State University|