Anxiety, Chronic Stress, Depression
Conditions
Keywords
Poverty, Discrimination, Stress, Coping
Brief summary
The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services. The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration. Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles
Interventions
Psychoeducational program to teach children coping skills, healthy identity development, and collective social action
Sponsors
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Children ages 11-14 at intake * Family income at or below 200% federal poverty level * Child speaks English * Parent speaks English or Spanish
Exclusion criteria
* Intellectual disability * Autism spectrum disorder * High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid)) * Severe depression (score of 19 or more on Patient health questionnaire (PHQ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the number of anxiety problems that children report. Anxiety problems will be measured using the Screen for Child Anxiety Related Disorders (SCARED), Child Behavior Checklist (CBCL), and Youth Self Report (YSR). |
| Depression | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the number of depressive symptoms that children report. Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9A), CBCL, and YSR. |
| Suicide Risk Markers | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the number of suicide risk markers that children report. Suicide risk markers will be measured using the Child Trauma Screen (CTS) and Mini Kid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement Coping Skills Acquisition | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the number of coping skills that children can report. Engagement Coping Skills Acquisition will be assessed with the Responses to Stress Questionnaire (RSQ), Children's Sadness Management Scale (CSMS) and Coping Skills Scale (CSS). |
| HPA Reactivity Profile | 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 (TSST) protocol |
| Collaborative Coping | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the number of collaborative coping skills that children report. Collaborative Coping will be assessed with the Collaborative Coping Discussion, Youth Civic and Character Measure (YCCM), and Social Skills Improvement System (SSIS). |
| Sociocultural Identity Development | Pre-post (3 months) and Pre-follow up (6 and 12 months) | Changes in the sociocultural identity beliefs that children report. Sociocultural identity beliefs will be assessed with the Child and Adolescent Social Support (CASS), Early Identity Exploration Scale (EIES), and Multigroup Ethnic Identity Measure (MEIM). |
Countries
United States
Contacts
CONTACTMartha E Wadsworth, PhD
CONTACTDara Babinksi, PhD
PRINCIPAL_INVESTIGATORMartha E Wadsworth, PhD
Penn State University
Outcome results
None listed