Clinical trial NCT04958694: CEDARS Intervention: A Coping, Emotional Development, & Stress Reduction Intervention
Official title: Coping and Emotional Development for Adolescents to Reduce Stress for Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Behavior
Stress Reduction
Adverse Childhood Experiences
Positive Attitude
Keywords: Adolescent Behavior
Stress Reduction
Adverse Childhood Experiences (ACEs)
CEDARS
Positive Affect Intervention
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.

Detailed description: This intervention has been adapted based on feedback from previous focus groups with adolescents, clinical staff, community stakeholders, and a CEDARS workgroup.

Participants will be divided into two groups - 20 in the intervention group and 20 in the waitlisted group.

Adolescents in the intervention group will participate in 7 weekly, 1-hour sessions. This online intervention will feature positive affect and stress reduction skills delivered via self-paced and self-guided modules. The skills are taught through brief didactic and semi-interactive videos followed by invitations and opportunities for practice within the session and at home. Participants will complete a baseline, mid-point, and post-intervention survey to determine the influence of the intervention.

There will be one follow-up survey with participants after the intervention. The survey will take place 1 month after the program has concluded.

Eligibility criteria: Inclusion Criteria:

* Adolescents ages 14-19
* Adolescents able to speak and understand English fluently
* Adolescents with reliable internet access (for virtual access to online modules)

Exclusion Criteria:

* Individuals younger than age 14 and older than age 19
* Individuals who are not able to speak or understand English fluently
* Individuals without reliable internet access

Primary outcomes:
measure: CEDARS Intervention
timeFrame: 8 Weeks
measure: Baseline, Midpoint, and Post-Intervention Surveys
timeFrame: 8 weeks
measure: Post-Intervention Follow-Up
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Nia Heard-Garris, MD,MSc,FAAP
role: PRINCIPAL_INVESTIGATOR
References: