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

Child Maltreatment Clinical Trial

— BFFs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893459
• Other study ID #: Pro00125559
• Secondary ID: R00HD103958
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2023
• Source: University of South Carolina
• Contact: Michelle P Brown, PhD
• Phone: (803) 766-4553
• Email: bffsstudy[@]sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Maltreatment
• Interpersonal Relations

Intervention

Behavioral:
• Debrief
Post-Stressor Discussion with a Friend

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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