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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of South Carolina

About this trial

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:

1. How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents? 2. 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

<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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Debrief

    Behavioral

    Post-Stressor Discussion with a Friend

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: DebriefExperimental treatment 1 intervention
Group B: No DebriefNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Respiratory sinus Arrhythmia (RSA) activity

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).

Time frame
Baseline
2

Youth Self Report (YSR)

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.

Time frame
6 Month Follow Up from Baseline
3

Child Behavior Checklist (CBCL)

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.

Time frame
6 Month Follow-Up from Baseline
4

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

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.

Time frame
6 Month Follow-Up from Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of South Carolina

Lead sponsor

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

Collaborator