Child MaltreatmentBFFsNCT05893459
Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in the Development of 13- to 17-Year-Old Adolescents
A study testing Debrief in people with Child Maltreatment and Interpersonal Relations, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Interpersonal Relations, Victimisation
- What is being tested?
- Debrief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29201
Michelle P Brown, PhD, bffsstudy@sc.edu
Michelle P Brown, PhD
About this study
Official title: 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:
- How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents?
- Which friendship experiences influence the associations between maltreatment and ability to regulate stress, as well as future mental health difficulties and revictimization?
Read more
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.
Read the 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.
- Conditions
- Child Maltreatment, Interpersonal Relations, Victimisation, Psychopathology, Electrocardiography
- Being tested
- Debrief
- 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
- Medical subject headings
- Psychological Well-Being, Psychological Trauma, Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DebriefBehavioural
Post-Stressor Discussion with a Friend
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Month Follow-Up from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start2 Dec 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michelle P. Brown, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893459
- Sponsor's protocol ID
- Pro00125559
- Other IDs
- R00HD103958
- Acronym
- BFFs
- Status last verified
- Jul 2024
- First submitted
- 4 May 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Parker, J. G., Rubin, K. H., Erath, S. A., Wojslawowicz, J. C., & Buskirk, A. A. (2006). Peer relationships, child development, and adjustment: A developmental psychopathology perspective. In D. Cicchetti & D. J. Cohen (Eds.), Developmental psychopathology: Theory and method (pp. 419-493). John Wiley & Sons Inc; US.
Mueller, E., & Silverman, N. (1989). Peer relations in maltreated children. In D. Cicchetti & Carlson, Vicki (Eds.), Child maltreatment: Theory and research on the causes and consequences of child abuse and neglect. (pp. 529-578). https://doi.org/10.1017/CBO9780511665707.018
Prinstein, M. J., & Giletta, M. (2016). Peer relations and developmental psychopathology. In D. Cicchetti (Ed.), Developmental psychopathology: Theory and method (pp. 527-579). John Wiley & Sons Inc; US.
Hartup, W. W., & Stevens, N. (1997). Friendships and adaptation in the life course. Psychological Bulletin, 121(3), 355-370. https://doi.org/10.1037/0033-2909.121.3.355
Calhoun CD, Helms SW, Heilbron N, Rudolph KD, Hastings PD, Prinstein MJ. Relational victimization, friendship, and adolescents' hypothalamic-pituitary-adrenal axis responses to an in vivo social stressor. Dev Psychopathol. 2014 Aug;26(3):605-18. doi: 10.1017/S0954579414000261.
PubMed 25047287Doom JR, Doyle CM, Gunnar MR. Social stress buffering by friends in childhood and adolescence: Effects on HPA and oxytocin activity. Soc Neurosci. 2017 Feb;12(1):8-21. doi: 10.1080/17470919.2016.1149095. Epub 2016 Feb 25.
PubMed 26899419Hodges EV, Boivin M, Vitaro F, Bukowski WM. The power of friendship: protection against an escalating cycle of peer victimization. Dev Psychol. 1999 Jan;35(1):94-101. doi: 10.1037//0012-1649.35.1.94.
PubMed 9923467Desir MP, Karatekin C. Characteristics of Disclosing Childhood Victimization and Risk of Revictimization in Young Adulthood. J Interpers Violence. 2021 Nov;36(21-22):NP12225-NP12251. doi: 10.1177/0886260519889932. Epub 2019 Dec 3.
PubMed 34755561Allen EK, Desir MP, Shenk CE. Child maltreatment and adolescent externalizing behavior: Examining the indirect and cross-lagged pathways of prosocial peer activities. Child Abuse Negl. 2021 Jan;111:104796. doi: 10.1016/j.chiabu.2020.104796. Epub 2020 Nov 12.
PubMed 33189371Brown, M. P. (2019). Developmental Pathways from Childhood Maltreatment to Adolescent Psychopathology, Substance Use, and Revictimization. http://conservancy.umn.edu/handle/11299/206323
Merritt DH, Snyder SM. Correlates of optimal behavior among child welfare-involved children: Perceived school peer connectedness, activity participation, social skills, and peer affiliation. Am J Orthopsychiatry. 2015 Sep;85(5):483-94. doi: 10.1037/ort0000091.
PubMed 26460707Ezzell CE, Swenson CC, Brondino MJ. The relationship of social support to physically abused children's adjustment. Child Abuse Negl. 2000 May;24(5):641-51. doi: 10.1016/s0145-2134(00)00123-x.
PubMed 10819096Folger, S. F., & Wright, M. O. (2013). Altering risk following child maltreatment: Family and friend support as protective factors. Journal of Family Violence, 28(4), 325-337. https://doi.org/10.1007/s10896-013-9510-4
Powers A, Ressler KJ, Bradley RG. The protective role of friendship on the effects of childhood abuse and depression. Depress Anxiety. 2009;26(1):46-53. doi: 10.1002/da.20534.
PubMed 18972449Long SJ, Evans RE, Fletcher A, Hewitt G, Murphy S, Young H, Moore GF. Comparison of substance use, subjective well-being and interpersonal relationships among young people in foster care and private households: a cross sectional analysis of the School Health Research Network survey in Wales. BMJ Open. 2017 Feb 20;7(2):e014198. doi: 10.1136/bmjopen-2016-014198.
PubMed 28219960
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in Adolescent Development
- ClinicalTrials.gov ID
- NCT05893459
- Acronym / sponsor ID
- BFFs / Pro00125559
- Conditions
- Child Maltreatment, Interpersonal Relations, Victimisation, Psychopathology, Electrocardiography
- Keywords
- Adolescents, Teenagers, Teens, Youth, Friendship, Friends, Mental Health, Psychopathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Debrief | Experimental | Behavioral: DebriefFollowing 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. |
| 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). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DebriefPost-Stressor Discussion with a Friend | Behavioural | Debrief |
Primary outcome
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).
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- BackgroundParker, J. G., Rubin, K. H., Erath, S. A., Wojslawowicz, J. C., & Buskirk, A. A. (2006). Peer relationships, child development, and adjustment: A developmental psychopathology perspective. In D. Cicchetti & D. J. Cohen (Eds.), Developmental psychopathology: Theory and method (pp. 419-493). John Wiley & Sons Inc; US.
- BackgroundMueller, E., & Silverman, N. (1989). Peer relations in maltreated children. In D. Cicchetti & Carlson, Vicki (Eds.), Child maltreatment: Theory and research on the causes and consequences of child abuse and neglect. (pp. 529-578). https://doi.org/10.1017/CBO9780511665707.018
- BackgroundPrinstein, M. J., & Giletta, M. (2016). Peer relations and developmental psychopathology. In D. Cicchetti (Ed.), Developmental psychopathology: Theory and method (pp. 527-579). John Wiley & Sons Inc; US.
- BackgroundHartup, W. W., & Stevens, N. (1997). Friendships and adaptation in the life course. Psychological Bulletin, 121(3), 355-370. https://doi.org/10.1037/0033-2909.121.3.355
- Background: PubMed 25047287Calhoun CD, Helms SW, Heilbron N, Rudolph KD, Hastings PD, Prinstein MJ. Relational victimization, friendship, and adolescents' hypothalamic-pituitary-adrenal axis responses to an in vivo social stressor. Dev Psychopathol. 2014 Aug;26(3):605-18. doi: 10.1017/S0954579414000261.
- Background: PubMed 26899419Doom JR, Doyle CM, Gunnar MR. Social stress buffering by friends in childhood and adolescence: Effects on HPA and oxytocin activity. Soc Neurosci. 2017 Feb;12(1):8-21. doi: 10.1080/17470919.2016.1149095. Epub 2016 Feb 25.
- Background: PubMed 9923467Hodges EV, Boivin M, Vitaro F, Bukowski WM. The power of friendship: protection against an escalating cycle of peer victimization. Dev Psychol. 1999 Jan;35(1):94-101. doi: 10.1037//0012-1649.35.1.94.
- Background: PubMed 34755561Desir MP, Karatekin C. Characteristics of Disclosing Childhood Victimization and Risk of Revictimization in Young Adulthood. J Interpers Violence. 2021 Nov;36(21-22):NP12225-NP12251. doi: 10.1177/0886260519889932. Epub 2019 Dec 3.
- Background: PubMed 33189371Allen EK, Desir MP, Shenk CE. Child maltreatment and adolescent externalizing behavior: Examining the indirect and cross-lagged pathways of prosocial peer activities. Child Abuse Negl. 2021 Jan;111:104796. doi: 10.1016/j.chiabu.2020.104796. Epub 2020 Nov 12.
- BackgroundBrown, M. P. (2019). Developmental Pathways from Childhood Maltreatment to Adolescent Psychopathology, Substance Use, and Revictimization. http://conservancy.umn.edu/handle/11299/206323
- Background: PubMed 26460707Merritt DH, Snyder SM. Correlates of optimal behavior among child welfare-involved children: Perceived school peer connectedness, activity participation, social skills, and peer affiliation. Am J Orthopsychiatry. 2015 Sep;85(5):483-94. doi: 10.1037/ort0000091.
- Background: PubMed 10819096Ezzell CE, Swenson CC, Brondino MJ. The relationship of social support to physically abused children's adjustment. Child Abuse Negl. 2000 May;24(5):641-51. doi: 10.1016/s0145-2134(00)00123-x.
- Individual participant dataSharing planned: Yes. 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).
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Substance Use Disorders, Parent-Child Relations
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
Enrolling by invitation
Prevalence of Childhood Maltreatment Among Women With Dysmenorrhea.
Dysmenorrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debrief in people with Child Maltreatment and Interpersonal Relations, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle P Brown, PhD ((803) 766-4553, bffsstudy@sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory sinus Arrhythmia (RSA) activity (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893459, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.