Clinical trial NCT05893459: Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in the Development of 13- to 17-Year-Old Adolescents
Official title: Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in Adolescent Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-06-08
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: BASIC_SCIENCE

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:

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory sinus Arrhythmia (RSA) activity
timeFrame: Baseline
measure: Youth Self Report (YSR)
timeFrame: 6 Month Follow Up from Baseline
measure: Child Behavior Checklist (CBCL)
timeFrame: 6 Month Follow-Up from Baseline
measure: 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
timeFrame: 6 Month Follow-Up from Baseline
measure: Juvenile Victimization Questionnaire (JVQ) total score
timeFrame: 6 Month Follow-Up from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
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