Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05893459
Study type Interventional
Source University of South Carolina
Contact Michelle P Brown, PhD
Phone (803) 766-4553
Email bffsstudy@sc.edu
Status Recruiting
Phase N/A
Start date December 2, 2023
Completion date March 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT02549287 - Comparative Effectiveness Trail to Reduce Child Maltreatment, Improve Client Outcomes and Examine Client Burden N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Terminated NCT01395238 - Enhancing Father's Ability to Support Their Preschool Child N/A
Completed NCT01791777 - Effectiveness and Cost-effectiveness of Coaching Models to Promote Implementation of an Evidence-based Parenting Program N/A
Completed NCT01458145 - Minding the Baby Home Visiting: Program Evaluation N/A
Completed NCT02415933 - Child Protective Outcomes Among Ultra-poor Families in Burkina Faso N/A
Completed NCT01304719 - A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project N/A
Recruiting NCT06109766 - Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth N/A
Withdrawn NCT02522741 - Safe Mothers, Safe Children Initiative N/A
Completed NCT04606199 - Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity N/A
Active, not recruiting NCT04163367 - A Randomized Controlled Study of Safer Kids: A Manualized Intervention to Prevent Child Abuse N/A
Recruiting NCT02225301 - iLookOut for Child Abuse -Online Learning Module for Early Childcare Providers N/A
Completed NCT02979262 - Intimate Partner Violence and Fatherhood Intervention in Residential Substance Abuse Treatment N/A
Completed NCT01294475 - Preventing Child Maltreatment Through A Cellular-Phone Technology-Based Parenting Program Phase 1/Phase 2
Completed NCT00819702 - A Safe Environment for Every Kid (SEEK): A Model for Primary Care N/A
Recruiting NCT06003582 - Co-production and Feasibility RCT of Intervention to Improve the Mental Health of Children With a Social Worker Phase 1/Phase 2
Recruiting NCT05233150 - Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO) N/A
Recruiting NCT04752618 - Safe Mothers, Safe Children Initiative N/A
Recruiting NCT05396625 - Reintegration of Children From Institutions in Azerbaijan N/A
Completed NCT04809272 - ePLH Pilot Study: Online Support Parent Groups - ParentChat N/A