Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02011438
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2013-06-07
Brief Title:
Coping With Adolescent Peer Victimization and Reducing AnxiousDepressed Symptoms
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Coping With Adolescent Peer Victimization and Reducing AnxiousDepressed Symptoms
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Among adolescents SAD and depression are prevalent highly comorbid and can be chronic and impairing Interpersonal peer victimization IPV is a key stressor that contributes to both social anxiety and depression in adolescents it includes relational eg social exclusion and reputational eg spreading rumors forms of peer victimization Currently there are no preventive interventions for adolescent SAD Also effective preventive interventions for adolescents have not yet integrated a focus on both social anxiety and depression or targeted specific peer risk factors Interventions for depression and for bullying have not addressed IPV which is less observable than overt victimization eg threats physical acts
Thus the Peers Emotions and Relationships PEERSUTalk intervention will take an integrated approach to reducing risk for SAD and depression by modifying and adapting an evidence-based intervention for depression Interpersonal Psychotherapy- Adolescents Skills Training IPT-AST that focuses on improving interpersonal skills and managing conflict We will add a elements of anxiety-based treatments eg exposures and b strategies for handling challenging peer experiences PEERSUTalk will have a positive focus and will target adolescents who report elevated symptoms of social anxiety andor depression and high levels of IPV
Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial
Aim Evaluate PEERSUTalk We will screen adolescents and conduct a pilot randomized trial of PEERS U Talk versus an EducationSupport ES condition with up to 60 high-risk adolescents
Hypothesis 1 Both PEERSUTalk and ES conditions will demonstrate a feasibility via rates of participation and study completion b intervention credibility via adolescents ratings of acceptability and satisfaction and c high rates of clinician fidelity to the respective manuals
Hypothesis 2 Adolescents randomized to PEERSUTalk will show improvements in primary outcomes less IPV fewer symptoms of social anxiety and depression improved clinician ratings relative to those in the ES condition
Hypothesis 3 The benefits of PEERSUTalk over ES will be apparent on the secondary outcomes of increased quality of close friendships increased peer support
Exploratory Aims We will examine 1 the durability and persistence of PEERSUTalk intervention effects versus ES on primary outcomes at 6-month follow-up and 2 potential moderators of response to the PEERSUTalk intervention recognizing that there are power limitations in doing so
Thus the Peers Emotions and Relationships PEERSUTalk intervention will take an integrated approach to reducing risk for SAD and depression by modifying and adapting an evidence-based intervention for depression Interpersonal Psychotherapy- Adolescents Skills Training IPT-AST that focuses on improving interpersonal skills and managing conflict We will add a elements of anxiety-based treatments eg exposures and b strategies for handling challenging peer experiences PEERSUTalk will have a positive focus and will target adolescents who report elevated symptoms of social anxiety andor depression and high levels of IPV
Following are the aims and hypotheses of the Pilot-Randomized Controlled Trial
Aim Evaluate PEERSUTalk We will screen adolescents and conduct a pilot randomized trial of PEERS U Talk versus an EducationSupport ES condition with up to 60 high-risk adolescents
Hypothesis 1 Both PEERSUTalk and ES conditions will demonstrate a feasibility via rates of participation and study completion b intervention credibility via adolescents ratings of acceptability and satisfaction and c high rates of clinician fidelity to the respective manuals
Hypothesis 2 Adolescents randomized to PEERSUTalk will show improvements in primary outcomes less IPV fewer symptoms of social anxiety and depression improved clinician ratings relative to those in the ES condition
Hypothesis 3 The benefits of PEERSUTalk over ES will be apparent on the secondary outcomes of increased quality of close friendships increased peer support
Exploratory Aims We will examine 1 the durability and persistence of PEERSUTalk intervention effects versus ES on primary outcomes at 6-month follow-up and 2 potential moderators of response to the PEERSUTalk intervention recognizing that there are power limitations in doing so
Detailed Description:
Participants in the Pilot-Randomized Controlled Trial P-RCT will be provided with PEERSUTalk or an EducationSupport ES control condition and will receive up to 3 individual and up to 10 group sessions of either Clinicians will be clinical postdoctoral trainee or doctoral students in clinical psychology with specialized training in evidence-based treatments for youth and experience working with child populations all clinicians will receive intensive training on the PEERSUTalk intervention prior to the P-RCT The research-specific intervention is conceptualized as a preventive intervention with the possibility of altering the length of the program as needed The intent is to develop PEERSUTalk so that it fits within a 60-90 minute period that meets about once a week during one school semester or could potentially be conducted as an after-school club As is typical of adolescent school-based prevention programs the groups will be co-ed
The PEERSUTalk intervention will consist of the following The first 2 sessions will be conducted individually during school and be modeled on procedures used in Interpersonal Psychotherapy - Adolescent Skills Training IPT-AST which are further modified to address issues of social anxiety and of IPV The first 2 sessions are about 45-60 minutes long a clinician meets with each adolescent to assess PV experiences and socially anxious and depressive symptoms provides a framework for the group and conducts an abbreviated interpersonal inventory The interpersonal inventory is a clinical interview in which the clinician and adolescent review significant peer and other relationships looking for strengths as well as problems and patterns of communication and problem-solving we have adapted this interview to incorporate IPV experiences and how they influence the adolescents feelings of social anxiety or depressive symptoms Together the adolescent and clinician identify interpersonal goals for the group An inventory of IPV experiences that are challenging for adolescents will also be obtained The next sessions up to 10 will be group-sessions up to 8 adolescents per group and will incorporate key elements of IPT-AST modified to integrate strategies for social anxiety taken from the Unified Protocol for the Treatment of Emotional Disorders in Youth UP-Y these treatment elements will be adapted to include examples of IPV experiences and strategies for handling them We plan to build on the IPT-AST intervention model because of its focus on improving interpersonal relations and enhancing social skills and supportive relationships However we also plan to incorporate strategies from the UP-Y to help teens manage social anxiety and for all sessions we will cover both social anxiety and depressive feelings and adjust the examples exercises and homework assignments so that they incorporate strategies for handling IPV experiences We also will review the Miami-Dade County Public Schools bullying policy so adolescents know how to handle more serious events should they arise Specifically the first group session will educate members about the symptoms of social anxiety and depression outline interpersonal problem areas and IPV experiences and discuss the relationship between feelings and interpersonal interactions During session 2 discussion and activities help adolescents understand the impact of their words and actions on others and the feelings that result from a given interaction including IPV experiences In session 3 adolescents are introduced to different communication and interpersonal strategies using I feel statements finding the right time to have a conversation and practice these skills by role-playing hypothetical situations including ones that involve IPV eg social exclusion handling an embarrassing situation In sessions 4-6 group members apply the interpersonal strategies to different relationships in their lives particularly peer relationships that are linked to IPV experiences and to socially anxious and depressive symptoms The group also discusses how these techniques can help the adolescents develop new relationships Adolescents try these techniques outside of group and report back about how the interactions went Session 7 is devoted to practicing exposure to social situations that are associated with uncomfortable feelings particularly those occurring in an interpersonal context Adolescents learn about positive friendship qualities and discuss how to identify these characteristics in others In session 8 adolescents discuss peer and cyber victimization as well as how to handle challenging peer situations During group sessions 9-10 the group reviews the strategies learned and changes that have occurred in the adolescents relationships and symptoms Group members are encouraged to continue the interpersonal work on their own
The PEERSUTalk intervention will consist of the following The first 2 sessions will be conducted individually during school and be modeled on procedures used in Interpersonal Psychotherapy - Adolescent Skills Training IPT-AST which are further modified to address issues of social anxiety and of IPV The first 2 sessions are about 45-60 minutes long a clinician meets with each adolescent to assess PV experiences and socially anxious and depressive symptoms provides a framework for the group and conducts an abbreviated interpersonal inventory The interpersonal inventory is a clinical interview in which the clinician and adolescent review significant peer and other relationships looking for strengths as well as problems and patterns of communication and problem-solving we have adapted this interview to incorporate IPV experiences and how they influence the adolescents feelings of social anxiety or depressive symptoms Together the adolescent and clinician identify interpersonal goals for the group An inventory of IPV experiences that are challenging for adolescents will also be obtained The next sessions up to 10 will be group-sessions up to 8 adolescents per group and will incorporate key elements of IPT-AST modified to integrate strategies for social anxiety taken from the Unified Protocol for the Treatment of Emotional Disorders in Youth UP-Y these treatment elements will be adapted to include examples of IPV experiences and strategies for handling them We plan to build on the IPT-AST intervention model because of its focus on improving interpersonal relations and enhancing social skills and supportive relationships However we also plan to incorporate strategies from the UP-Y to help teens manage social anxiety and for all sessions we will cover both social anxiety and depressive feelings and adjust the examples exercises and homework assignments so that they incorporate strategies for handling IPV experiences We also will review the Miami-Dade County Public Schools bullying policy so adolescents know how to handle more serious events should they arise Specifically the first group session will educate members about the symptoms of social anxiety and depression outline interpersonal problem areas and IPV experiences and discuss the relationship between feelings and interpersonal interactions During session 2 discussion and activities help adolescents understand the impact of their words and actions on others and the feelings that result from a given interaction including IPV experiences In session 3 adolescents are introduced to different communication and interpersonal strategies using I feel statements finding the right time to have a conversation and practice these skills by role-playing hypothetical situations including ones that involve IPV eg social exclusion handling an embarrassing situation In sessions 4-6 group members apply the interpersonal strategies to different relationships in their lives particularly peer relationships that are linked to IPV experiences and to socially anxious and depressive symptoms The group also discusses how these techniques can help the adolescents develop new relationships Adolescents try these techniques outside of group and report back about how the interactions went Session 7 is devoted to practicing exposure to social situations that are associated with uncomfortable feelings particularly those occurring in an interpersonal context Adolescents learn about positive friendship qualities and discuss how to identify these characteristics in others In session 8 adolescents discuss peer and cyber victimization as well as how to handle challenging peer situations During group sessions 9-10 the group reviews the strategies learned and changes that have occurred in the adolescents relationships and symptoms Group members are encouraged to continue the interpersonal work on their own
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None