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

NCT05893459 | Recruiting

• 2 other identifiers: Pro00125559R00HD103958
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Child Maltreatment; Interpersonal Relations; Victimisation; Psychopathology; Electrocardiography

Keywords

Adolescents; Teenagers; Teens; Youth; Friendship; Friends; Mental Health; Psychopathology; Psychological Trauma; Childhood Trauma; Child Abuse; Child Neglect; Child Maltreatment; Psychophysiology; Respiratory Sinus Arrhythmia; Longitudinal Studies

Outcome Measures

Primary Outcomes (5)

• 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).

  Baseline

• 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.

  6 Month Follow Up from Baseline

• 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.

  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

  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

  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

Study Arms (2)

Debrief

EXPERIMENTAL

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

No Debrief

NO INTERVENTION

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

Interventions

Debrief BEHAVIORAL

Post-Stressor Discussion with a Friend

Debrief

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29201, United States

RECRUITING

Related Publications (35)

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MeSH Terms

Conditions

Psychological Well-Being; Psychological Trauma; Arrhythmia, Sinus

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michelle P Brown, PhD

CONTACT

(803) 766-4553; bffsstudy@sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 8, 2023
• Study Start: December 2, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication
• 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.

Locations

US (1)