Skills Group for Youth at Clinical High-Risk for Psychosis

NCT05398120 | Recruiting

• 2 other identifiers: STUDY211200121 H79 SM081196-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended to test the feasibility of an integrated cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) skills group for adolescents and young adults at clinical high-risk (CHR) for psychosis. The current study applies a skills group drawing from evidence-based practices (e.g., cognitive behavioral therapy (CBT), dialectical behavioral therapy (DBT)) to those at CHR for psychosis. Up to 30 CHR individuals (starting with a minimum of 3 participants, N accounts for attrition as well), aged 13-18, already receiving clinical services within the HOPE team at University of Pittsburgh will be offered a weekly skills group. Data collected on feasibility and outcome measures will occur pre (within 1 month) -post (up to 4-5 months) and half-way (up to 2-3 months) through the intervention. Taken together, the aim of the proposed intervention is to provide novel insights regarding the utility of a newly developed intervention that integrates both CBT and DBT skills for those at CHR for psychosis.

Conditions

Clinical High-Risk; Psychological

Keywords

Group intervention; Dialectical behavioral therapy skills; Cognitive behavioral therapy skills; Psychosis-risk

Outcome Measures

Primary Outcomes (10)

• Attrition

  Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.

  Up to 5 months

• Attendance

  Feasibility measure; daily attendance will be recorded.

  Up to 5 months

• Modified Quick Lecomte and Leclerc Scale

  Feasibility measure; this modified measure is a a 15-item feasibility measure that assesses feelings about the relevance and importance of group, alliance with the therapists, the group cohesion, appreciation of the group therapy, optimism for the future (five items), feelings about self and others (two items), current mood/anxiety (seven items), distressing thoughts (one item), and feelings about meeting goals (one item). The measure collects data on a 3-point likert scale (0-2), with higher score indicating more group satisfaction/improvement. A mean total score will be collected for each dimension and can range from 0-2. An improvement score taking the proportion of better than usual compared to worse than usual can be calculated for each month of therapy as well.

  Up to 5 months

• Participation Scale

  Feasibility measure; this is a 9-item checklist assessing the participation and behavior of each group member, with each item rated on a 0 (absence of behavior) to 4 (strong presence of behavior) scale. A total score is computed for each person (range 0-36 scale), as well as an average for all group members, with higher scores indicating more group engagement and prosocial behaviors.

  Up to 5 months

• Change from baseline in the participant group survey at up to 3 months

  Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.

  Baseline vs. up to 3 months

• Change from up to 3 months in the participant group survey at up to 5 months

  Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.

  Up to 3 months vs up to 5 months

• Change from baseline in the participant group survey at up to 5 months

  Feasibility measure; this includes 3 questions about the goals for group and asks general questions about how different areas of the individual's life is going (e.g., feeling present, coping with stress, feeling towards self, 10 questions ranging from 0-40) - individuals are to answer on a 0 (much worse) to 4 (greatly improved) scale with higher scores signaling more improvement. Furthermore, this questionnaire also includes questions about the quality of the group from the participants perspective which will provide qualitative data.

  Baseline vs. up to 5 months

• Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months

  A satisfaction 13-item scale that asks the individual to indicate their level of satisfaction of the therapy and therapists in the group treatment. Scores fall on a 1 (strong disagree) to 5 (strongly agree) scale with higher numbers indicating higher satisfaction. Scores range from 12-60. There is an additional item that falls on a 1-5 scale that asks about how the tre (atment helped with the specific problem that led to therapy, with higher scores indicating that therapy made things worse (range is 1-5).

  Baseline vs. up to 3 months

• Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months

  A satisfaction 13-item scale that asks the individual to indicate their level of satisfaction of the therapy and therapists in the group treatment. Scores fall on a 1 (strong disagree) to 5 (strongly agree) scale with higher numbers indicating higher satisfaction. Scores range from 12-60. There is an additional item that falls on a 1-5 scale that asks about how the tre (atment helped with the specific problem that led to therapy, with higher scores indicating that therapy made things worse (range is 1-5).

  Up to 3 months vs. up to 5 months.

• Fidelity scores

  Fidelity scores developed specifically for this group asking questions about the structure of the group meant to be filled out by co-leaders (e.g., was there a mindfulness practice in the session?). Each item can have a Yes or No response. More Yes responses indicate more fidelity. There are a total of 9 items.

  Up to 5 months

Secondary Outcomes (43)

• Change from baseline in Lehman Quality of Life Functional Assessment at up to 3 months.

  Baseline vs. up to 3 months

• Change from up to 3 months in Lehman Quality of Life Functional Assessment at up to 5 months.

  Up to 3 months vs. up to 5 months

• Change from baseline in Lehman Quality of Life Functional Assessment at up to 5 months.

  Baseline vs. up to 5 months

• Change from baseline in Perceived Stress Scale at up to 3 months

  Baseline to up to 3 months

• Change from up to 3 months in Perceived Stress Scale at up to 5 months.

  Up to 3 months vs. up to 5 months

Study Arms (1)

Skills Group

EXPERIMENTAL

There will be one condition which is the group and participants will complete feasibility and outcome measures at baseline, at midpoint, and at the end of the group.

Behavioral: Skills Group

Interventions

Skills Group BEHAVIORAL

Adolescents and young adults with a CHR syndrome ages 13-18 will complete feasibility and outcome measures while participating in a weekly skills group for 6 months.

Also known as: Psychosis-risk skills group

Skills Group

Eligibility Criteria

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

You may qualify if:

• years of age
• Meet criteria for clinical high-risk syndrome (i.e., at clinical high risk for developing a psychotic disorder). CHR status is determined based off of scoring a 3 (moderate) - 5 (severe) on the Structured Interview for Psychosis-Risk Syndromes and/or having a first degree relative with psychotic disorder and/or the individual meets criteria for schizotypal personality disorder. Additionally individuals with a brief intermittent psychotic symptoms can be included as well (e.g., frankly psychotic symptoms that are very brief)
• Individuals must be enrolled in the HOPE team at the University of Pittsburgh since this group is embedded within that service

You may not qualify if:

• Group member meeting criteria for a current/past psychotic disorder
• Must be the parent, legal guardian of a 13-18 year-old
• For parents of CHR adolescents, their adolescent must meet criteria for a psychosis-risk syndrome

Sponsors & Collaborators

• University of Pittsburgh: lead
• Substance Abuse and Mental Health Services Administration (SAMHSA): collaborator

Study Sites (1)

Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

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Study Officials

• Leslie Horton, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Gupta, PHD

CONTACT

412-246-5845; guptat3@upmc.edu

Lauren Bylsma, PHD

CONTACT

412-624-8363; bylsmalm@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is one condition so masking is not relevant
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants already receiving services in the psychosis-risk clinic at the University of Pittsburgh will be asked to participate in the psychosis-risk skills group. Data collected on feasibility and outcome measures will occur pre (within 1 month) -post (up to 4-5 months) and half-way (up to 2-3 months) through the intervention.

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 31, 2022
• Study Start: April 26, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Data sharing will be occur when specific requests to analyze data are made by investigators in the field and in line with grant funder data sharing policies

Locations

US (1)