HOPE TEAM - Clinical High Risk Group CBSST
Primary Purpose
Prodromal Symptoms, Prodromal Stage, Prodromal States
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional health services research trial for Prodromal Symptoms
Eligibility Criteria
Inclusion Criteria:
- Patients may be included if they are 13-19 years old and receiving individual therapy or professional assessment/clinical evaluation as part of the HOPE TEAM.
- Due to the nature of the definition of "clinical high risk status," these patients may have a variety of clinical diagnoses, but all will be receiving individual therapy or clinical evaluation through the HOPE TEAM due to their elevated risk for developing a psychotic disorder.
- The individual therapy being provided to patients who are also eligible for HOPE TEAM Group may also vary based on their individual needs and therapy goals.
Exclusion Criteria:
- HOPE TEAM adolescents may be excluded if they express an unwillingness to participate in weekly group therapy and abide by group rules.
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pilot Treatment Arm
Arm Description
Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, & Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, & Wykes, 2016).
Outcomes
Primary Outcome Measures
Perceived Utility of CBSST in a CHR group therapy setting
The goals of this pilot project are to: 1) identify which aspects of the group perceived to be most and least helpful and relevant by participating adolescents, and 2) evaluate whether participants perceive that the group has impacted their clinical symptoms and functioning.
To measure the perceived utility of CBSST in a CHR group therapy setting, a qualitative analysis of the open-ended HOPE Group Pre- and Post-Surveys will be conducted. In addition, the results of a Likert scale on the pre- and post- surveys will be analyzed. This scale presents examples of 7 domains of skills (e.g. "Thinking clearly") and participants are asked how much they feel the group has assisted them in improving this skill on a five-point Likert scale ("much worse" to "greatly improved").
Non-specific, CHR symptom reduction
An additional goal of this pilot project is to address and reduce the number or severity of non-specific, sub-threshold symptoms of the clinical high-risk phase of psychotic disorders experienced by the group members.
To measure symptom reduction, pre-group and post-group scores on the Youth Inventory Self-Report, or Adult-Self Report Inventory (depending on participant age) will be compared for each individual who completed group therapy. Symptom reduction is defined as a decrease in the overall total scores on the Youth Inventory Self-Report or Adult-Self Report Inventory (i.e. the number of symptoms reported by participants).
Secondary Outcome Measures
Full Information
NCT ID
NCT03738046
First Posted
October 16, 2018
Last Updated
February 5, 2020
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT03738046
Brief Title
HOPE TEAM - Clinical High Risk Group CBSST
Official Title
Help Overcoming Prodromal Experiences Through Early Assessment & Management - Clinical High Risk Group CBSST
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
We had a change in staffing that precluded pursing this project
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Community-based treatments for adolescents at risk for psychosis are not widely available, nor are there established, gold-standard psychosocial group interventions for this population. The HOPE TEAM, Helping Overcome Prodromal Experiences through Treatment and Evaluation of Adolescent Minds (PI: Bachman; funded by The Pittsburgh Foundation) is an early detection and intervention program for youth at clinical high risk for psychosis which aims to help them by engaging existing community resources, providing assessment, and offering trauma-informed psychotherapy. Embedded within the Family Care Connection Center at Turtle Creek, the HOPE TEAM offers individual psychotherapy as part of its clinical service model. The present study seeks to evaluate, in a small and preliminary sample (n = 20), the feasibility and effectiveness of a 24-week Cognitive-Behavioral Social Skills Therapy (CBSST) group intervention for CHR adolescents who are part of the HOPE TEAM. To that end, the current proposal will seek to conduct brief research assessments to assess the group members' perceptions of the group's utility, as well as their current clinical symptoms and functioning prior to, during, and after participating in this group. The goals of this pilot project are to 1) identify which aspects of the group perceived to be most and least helpful by participating adolescents, and 2) evaluate whether participation in the group meaningfully improves participants' clinical symptoms and functioning. The investigators aim to use these pilot data to guide future selection of treatment targets in this clinical practice, and to identify future strategies for increasing satisfaction and retention in community-based group interventions for CHR adolescents.
Detailed Description
Accumulating evidence suggests that psychotherapy, particularly CBT (Cognitive-Behavior Therapy) may effectively lower clinical high risk (CHR) youths' risk of developing psychosis. This is consistent with converging evidence that CBT, in both individual and group delivery formats, is effective for reducing positive symptoms of psychosis in those with a diagnosis of schizophrenia. Social Skills Training (SST) for psychosis may be more beneficial for treating negative symptoms and social impairment that accompany schizophrenia.
Given these findings, a group therapy modality combining CBT and SST (CBSST) has been developed with the goal of addressing multiple domains of symptoms and impairments; outcomes of randomized clinical trials have shown that individuals with schizophrenia who received CBSST had improved functioning and less severe psychotic symptoms.4 Furthermore, CBSST is also feasible and well accepted for adolescents and young adults with a first episode of psychosis. However, there are no established, gold-standard psychosocial group interventions for CHR youth, nor have studies specifically investigated the efficacy of CBSST for this population. Since CBSST is effective in adult psychosis, a modified version of this group treatment modality may be useful for CHR adolescents. Given the high levels of victimization, adversity, and stress in community CHR samples, modifications to CBSST for CHR youth should explicitly include a focus on stress coping.
Any clients ages 13-19 already enrolled in HOPE TEAM assessment will be informed about the availability of the HOPE Group by their individual clinician. If interested, potential participants (and their parents, if under age 18) will meet with study PI and Group Leader, to discuss the study and complete the informed consent process. As part of this process, adolescents (and their parents if under 18) will be made aware that their choice to participate or not in the HOPE Group will not affect any other services proved through the HOPE TEAM. Once a minimum of 4 participants are recruited for the HOPE group, the first session will be scheduled.
Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis.
Within 2 weeks of the first group session, participants will complete a very brief (25-40 minute) pre-group assessment battery in the HOPE Team offices with the PI, consisting of the:
Youth Inventory 4-Self-Report (YSI-4; ages 14-17) or Adult Self-Report Inventory-4 (ASI-4; ages 18) are 128-item measures that takes approximately 10-15 minutes to complete. Assesses clinical symptoms, compared to a normed sample, across disruptive, mood, anxiety, and other clinical disorders.
Prodromal Questionnaire, Brief Version (PQ-B); a 21- item dimensional self-report measure of psychotic symptoms, which takes approximately 5-10 minutes to complete.
Defeatist Performance Attitudes Test, a 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. This measure takes approximately 5 minutes to complete.
HOPE Group Pre-Survey: A 5-item survey assessing open-ended thoughts about joining a group; takes approximately 5-10 minutes.
To allow for flexibility in the community treatment setting, the HOPE Group will adopt a modular rolling admissions approach to enrollment, in which new group members (up to a maximum group membership of 10) can be enrolled at the start of each module (every 6 sessions). In this case, the pre-group assessment battery will be completed with the participant within 2 weeks of their first group.
Each session will consist of collaborative agenda-setting, review of at-home practice, introduction of a new skill, skill practice, and assigning in-home practice/ summarizing the session. The end of each 60-90-minute group session will consist of 5 minutes of assessment. Group members will complete the:
Modified QuickLL, a 14-item measure assessing how participants currently view themselves and their engagement in that day's group session. Each item is rated on a 3-point scale and the measure is totaled, with higher totals indicating better self-perception and greater engagement in the group. This measure takes approximately 2 minutes to complete.
Simultaneously, both group leaders will complete the Participation Scale, a 9-item checklist assessing the participation and behavior of each group member, with each item rated from 0 (absence of behavior) to 4 (strong presence of behavior). A total score is computed for each participant, as well as an average for all group members, with higher scores indicated more group engagement and prosocial behaviors.
Within two weeks after completion of the 24-week Group, participants will complete a very brief (25-40 minute) post-group assessment battery in the HOPE Team offices with the PI, consisting of the:
Youth Inventory 4-Self-Report, or Adult Self-Report Inventory-4
Prodromal Questionnaire, Brief Version
Defeatist Performance Attitudes test
HOPE Group Post-Survey: A 5-item survey assessing open-ended thoughts about experiences in a group; takes approximately 5-10 minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prodromal Symptoms, Prodromal Stage, Prodromal States, Psychosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pilot Treatment Arm
Arm Type
Experimental
Arm Description
Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, & Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, & Wykes, 2016).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
Cognitive Behavioral Social Skills Therapy
Intervention Description
Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, & Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, & Wykes, 2016).
Primary Outcome Measure Information:
Title
Perceived Utility of CBSST in a CHR group therapy setting
Description
The goals of this pilot project are to: 1) identify which aspects of the group perceived to be most and least helpful and relevant by participating adolescents, and 2) evaluate whether participants perceive that the group has impacted their clinical symptoms and functioning.
To measure the perceived utility of CBSST in a CHR group therapy setting, a qualitative analysis of the open-ended HOPE Group Pre- and Post-Surveys will be conducted. In addition, the results of a Likert scale on the pre- and post- surveys will be analyzed. This scale presents examples of 7 domains of skills (e.g. "Thinking clearly") and participants are asked how much they feel the group has assisted them in improving this skill on a five-point Likert scale ("much worse" to "greatly improved").
Time Frame
6 months (end of group)
Title
Non-specific, CHR symptom reduction
Description
An additional goal of this pilot project is to address and reduce the number or severity of non-specific, sub-threshold symptoms of the clinical high-risk phase of psychotic disorders experienced by the group members.
To measure symptom reduction, pre-group and post-group scores on the Youth Inventory Self-Report, or Adult-Self Report Inventory (depending on participant age) will be compared for each individual who completed group therapy. Symptom reduction is defined as a decrease in the overall total scores on the Youth Inventory Self-Report or Adult-Self Report Inventory (i.e. the number of symptoms reported by participants).
Time Frame
6 months (end of group)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients may be included if they are 13-19 years old and receiving individual therapy or professional assessment/clinical evaluation as part of the HOPE TEAM.
Due to the nature of the definition of "clinical high risk status," these patients may have a variety of clinical diagnoses, but all will be receiving individual therapy or clinical evaluation through the HOPE TEAM due to their elevated risk for developing a psychotic disorder.
The individual therapy being provided to patients who are also eligible for HOPE TEAM Group may also vary based on their individual needs and therapy goals.
Exclusion Criteria:
HOPE TEAM adolescents may be excluded if they express an unwillingness to participate in weekly group therapy and abide by group rules.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Horton, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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HOPE TEAM - Clinical High Risk Group CBSST
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