BFFs: Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in the Development of 13- to 17-Year-Old Adolescents

Sponsor

University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05893459

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

120

Enrollment

Arms

19.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to investigate how the friendship experiences of maltreated (i.e., abused and/or neglected) and non-maltreated adolescents differentially influence their risk for adverse outcomes. The main questions it aims to answer are:

How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents?
Which friendship experiences influence the associations between maltreatment and ability to regulate stress, as well as future mental health difficulties and revictimization?

Participants will:

Attend the initial study visit on the campus of the University of South Carolina with their primary caregiver and a best friend during which they will:
Complete study questionnaires
Be connected to a device that records their physical ability to manage stress
Complete a task during which they will be audio and video recorded and complete a brief assessment rating how they are feeling at different times during task completion
Depending on which research group they are placed in, be assigned to discuss their experience doing this task with their friend (intervention group) or sit quietly in a room for 5 minutes (comparison group)
The follow-up study visit will involve completion of study questionnaires online or via mail 6 months later

Additionally, the participant's caregiver and friend will complete study questionnaires.

Researchers will compare the intervention group (debriefs with a friend) and comparison group (sits quietly for 5 minutes) to see if the presence of and discussion with the friend influences their physical ability to regulate stress and future outcomes.

Condition or Disease	Intervention/Treatment	Phase
Child Maltreatment Interpersonal Relations	Behavioral: Debrief	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Debrief - Following exposure to a laboratory stressor, adolescent participants will be randomly assigned to either debrief their experience with a friend or sit by themselves (standard procedure) while their psychophysiological reactivity is recorded using an electrocardiogram (ECG).Debrief - Following exposure to a laboratory stressor, adolescent participants will be randomly assigned to either debrief their experience with a friend or sit by themselves (standard procedure) while their psychophysiological reactivity is recorded using an electrocardiogram (ECG).

Masking:

Single (Investigator)

Primary Purpose:

Basic Science

Official Title:

Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in Adolescent Development

Anticipated Study Start Date :

Jul 10, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Debrief Following exposure to a laboratory stressor, participants in this arm will debrief their experience with a friend for 5 minutes while their psychophysiological reactivity is recorded using an electrocardiogram (ECG). Their interaction will be audio and video recorded for later observational coding of their friend's validating and invalidating behaviors during the conversation.	Behavioral: Debrief Post-Stressor Discussion with a Friend
No Intervention: No Debrief Following exposure to a laboratory stressor, participants in this arm will sit by themselves while their psychophysiological reactivity is recorded using an electrocardiogram (ECG).

Arm

Intervention/Treatment

Experimental: Debrief

Following exposure to a laboratory stressor, participants in this arm will debrief their experience with a friend for 5 minutes while their psychophysiological reactivity is recorded using an electrocardiogram (ECG). Their interaction will be audio and video recorded for later observational coding of their friend's validating and invalidating behaviors during the conversation.

Behavioral: Debrief

Post-Stressor Discussion with a Friend

No Intervention: No Debrief

Following exposure to a laboratory stressor, participants in this arm will sit by themselves while their psychophysiological reactivity is recorded using an electrocardiogram (ECG).

Outcome Measures

Primary Outcome Measures

Respiratory sinus Arrhythmia (RSA) activity [Baseline]
RSA activity, including resting RSA (prior to Trier Social Stress Test [TSST] procedure), RSA reactivity (difference between RSA activity during stressor exposure and resting RSA), and RSA recovery (difference between RSA activity during 5 minutes post stressor exposure whether during debriefing with friend or in isolation and RSA activity during stressor exposure).
Youth Self Report (YSR) [6 Month Follow Up from Baseline]
YSR, which is completed by the adolescent and assesses the participant's internalizing (e.g., anxious, depressed) and externalizing (e.g., aggression, rule-breaking behavior) symptoms. Scale scores are reported for Internalizing and Externalizing symptoms and higher scores indicate greater symptoms and a worse outcome. Possible raw scores range from 0 to 62 for Internalizing Symptoms and 0 to 60 for Externalizing Symptoms. Raw scores are transformed to standardized T scores normed by age and gender ranging from 26 to 100 for Internalizing and 25 to 100 for Externalizing.
Child Behavior Checklist (CBCL) [6 Month Follow-Up from Baseline]
CBCL, which is a parallel form to the YSR completed by the caregiver and assesses the participant's internalizing (e.g., anxious, depressed) and externalizing (e.g., aggression, rule-breaking behavior) symptoms. Scale scores are reported for Internalizing and Externalizing symptoms and higher scores indicate greater symptoms and a worse outcome. Possible raw scores range from 0 to 62 for Internalizing Symptoms and 0 to 66 for Externalizing Symptoms. Raw scores are transformed to standardized T scores normed by age and gender ranging from 31 to 100 for Internalizing and 30 to 100 for Externalizing.
University of California, Los Angeles Posttraumatic Stress Disorder Reaction Index (UCLA PTSD-RI) for the Diagnostic and Statistical Manual of Mental Disorders -5th Edition (DSM-5) Total Score [6 Month Follow-Up from Baseline]
UCLA PTSD Reaction Index for the DSM-5, which is completed by the adolescent participant and their caregiver and provides an overall PTSD symptom based on DSM-5 criteria. Total score ranges from 0 to 80 and higher scores indicating greater symptoms and a worse outcome.
Juvenile Victimization Questionnaire (JVQ) total score [6 Month Follow-Up from Baseline]
JVQ, which is completed by the adolescent participant and assesses experiences with five areas of youth victimization (i.e., conventional crime, peer and sibling victimization, maltreated, sexual victimization, and witnessing and indirect victimization) that has occurred within the past six months since the first study visit. A count of total experiences endorsed ranging from 0 to 34 is computed with a higher score indicating more victimization and a worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

13 to 17 years old at first study visit
Qualify as either maltreated (endorses history of maltreatment - physical abuse, sexual abuse, emotional maltreatment, or neglect and/or has substantiated record of child maltreatment per Department of Social Services [DSS] records) or non-maltreated (denies history of maltreatment and/or no substantiated record of child maltreatment per DSS records)
Parent participating in the study visit is a non-offending caregiver (no record of substantiated maltreatment against the adolescent participant)
Participant identifies a best friend who is not a sibling or previous/current romantic partner who can accompany them to the study visit
Participant, caregiver, and friend are fluent in written and spoken English

Exclusion Criteria:

<13 or >17 at time of first study visit
No available non-offending parent or guardian/caregiver to participate in the study
No best friend identified to accompany the participant to the study
Participant, caregiver, or friend is not fluent in written and spoken English