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

July 12, 2024 updated by: Michelle P. Brown, University of South Carolina

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

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.

Study Overview

Detailed Description

When potential participants indicate interest in the study, participants and caregivers will first complete pre-screening measures to inquire about child welfare system involvement and determine eligibility. If eligible, they will be contacted for scheduling and the caregiver will be administered a brief trauma screen to determine maltreatment status and adolescents will identify a friend to accompany them to the assessment. The study team will then schedule a laboratory visit and participants will be instructed to bring their friend and caregiver. The participant, caregiver, friend, and friend's caregiver will then complete consent and assent procedures. The adolescent and friend will then complete measures related to their friendship experiences as applicable prior to administration of a laboratory stressor, the Trier Social Stress Test (TSST). Adolescents will then be randomly assigned to discuss their TSST experience with their friend or wait in a room by themselves (standard TSST procedure) using a blocked randomization procedure to balance the two groups on maltreatment status and gender, thereby reducing bias and confounding that may be attributable to these factors. This randomization will be performed using a computer algorithm with randomly selected block sizes of 4, 6, and 8. There will be twice as many participants being randomized to debrief with a friend as are randomized to the standard TSST procedure. This is done for several reasons. First, this is done to maximize power for examining the potential moderating effect of friendship experiences (i.e., validating and invalidating responses from friends following adolescents' stressor exposure) that can only be assessed if participants are randomized to this condition. Second, the standard procedure has already been extensively implemented and studied in developmental/clinical research, including with children who have experienced maltreatment and other forms of adversity along with children's/adolescent's psychophysiological reactivity in response to undergoing this stressor. Thus, it is important to collect more novel data regarding how the presence of a friend and their accompanying responses toward the participant influence adolescents' ability to recover following this stressor.

Their psychophysiological, or or respiratory sinus arrhythmia (RSA) activity, will be measured using an electrocardiogram (ECG) before, during, and after the TSST during either the 5-minute post-TSST discussion with their friend or a 5-minute period during which the adolescent is by themselves. For those assigned to debrief with a friend, validating and invalidating responses of the friend toward the adolescent participant will be observed and coded. Participants will be followed up six months later at Time 2 (T2) and adolescents and their parents will complete additional measures related to friendship, psychopathology, and revictimization experiences, online or via mail, if needed.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michelle P Brown, PhD
  • Phone Number: (803) 766-4553
  • Email: bffsstudy@sc.edu

Study Locations

    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • University of South Carolina
        • Contact:
        • Principal Investigator:
          • Michelle P Brown, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory sinus Arrhythmia (RSA) activity
Time Frame: 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).
Baseline
Youth Self Report (YSR)
Time Frame: 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.
6 Month Follow Up from Baseline
Child Behavior Checklist (CBCL)
Time Frame: 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.
6 Month Follow-Up from Baseline
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
Time Frame: 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.
6 Month Follow-Up from Baseline
Juvenile Victimization Questionnaire (JVQ) total score
Time Frame: 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.
6 Month Follow-Up from Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

June 5, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available upon request by the PI, in a format that protects the privacy and anonymity of study participants. Specifically, even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be shared via a secure institutionally supported data archive (e.g., Microsoft One Drive and/or Box).

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

Data will be made available upon request by the PI, in a format that protects the privacy and anonymity of study participants. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be shared via a secure institutionally supported data archive (e.g., Microsoft One Drive and/or Box). PI will review all data sharing requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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