HOPE TEAM - Clinical High Risk Group CBSST

NCT03738046 | Withdrawn

• 1 other identifier: PRO18010551
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prodromal Symptoms; Prodromal Stage; Prodromal States; Psychosis

Outcome Measures

Primary Outcomes (2)

• 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").

  6 months (end of group)

• 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).

  6 months (end of group)

Study Arms (1)

Pilot Treatment Arm

EXPERIMENTAL

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).

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

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).

Also known as: Cognitive Behavioral Social Skills Therapy

Pilot Treatment Arm

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• HOPE TEAM adolescents may be excluded if they express an unwillingness to participate in weekly group therapy and abide by group rules.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Prodromal Symptoms; Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leslie Horton, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: November 13, 2018
• Study Start: September 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)