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Recruiting NCT05398120

Skills Group for Youth at Clinical High-Risk for Psychosis

No phase Interventional Clinical High-Risk Psychological

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Skills Group.
Who it may be relevant to
Registry conditions: Clinical High-Risk, Psychological. Basic parameters: 13 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis

Overview

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.

Detailed description

The goal of the current study is to integrate cognitive behavioral therapy and dialectical behavioral therapy skills and implement in a group format to a sample of individuals at risk for developing a psychotic disorder. These data have the potential to provide a foundation for intervention development in this area. The group will include weekly sessions for 90 minutes with up to 8 members in the group at a time. Each session will include mindfulness, homework review, and skill development. Each individual in the group will be asked to complete the group for 15-weeks. In the first section of the group, skills will be taught to manage and reduce stress. The second set of skills will include teaching individuals how to improve self-disturbances. The final section of the group will include helping participants improve social skills. Furthermore, parents will be asked to participate in a parent/guardian session 1x a month and will also be asked to also fill out a post-group surveys although this is not mandatory.

It is important to note that all hypotheses are exploratory given the feasibility nature of this study and the sample size. Even so, it is predicted, in an exploratory fashion, that this group will be feasible to implement and there will be improvements in symptoms and functioning.

Changes have been made starting Nov 2024 to the group given the feedback received: (1) Instead of 21-weeks, the group has been modified to to 15-weeks, (2) skills are consistent across stages, implementing only standard DBT skills (instead of radically-open DBT: this applies to stage 3 of the group where the goal is intended to improve social impairments), and (3) the number of outcome measures have been reduced and streamlined to follow the general clinic assessment battery to reduce participant burden.

Interventions

  • Behavioral Skills Group
    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.

Primary outcome measures

  • Attrition [Time frame: Up to 5 months]
  • Attendance [Time frame: Up to 5 months]
  • Modified Quick Lecomte and Leclerc Scale [Time frame: Up to 5 months]
  • Participation Scale [Time frame: Up to 5 months]
  • Change from baseline in the participant group survey at up to 3 months [Time frame: Baseline vs. up to 3 months]
  • Change from up to 3 months in the participant group survey at up to 5 months [Time frame: Up to 3 months vs up to 5 months]
  • Change from baseline in the participant group survey at up to 5 months [Time frame: Baseline vs. up to 5 months]
  • Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months [Time frame: Baseline vs. up to 3 months]
  • Change from 3 months in Satisfaction with Therapy and Therapist Scale at up to 5 months [Time frame: Up to 3 months vs. up to 5 months.]
  • Fidelity scores [Time frame: Up to 5 months]
Secondary outcome measures (12)
  • Change from baseline in Lehman Quality of Life Functional Assessment at up to 3 months. [Time frame: Baseline vs. up to 3 months]
  • Change from up to 3 months in Lehman Quality of Life Functional Assessment at up to 5 months. [Time frame: Up to 3 months vs. up to 5 months]
  • Change from baseline in Lehman Quality of Life Functional Assessment at up to 5 months. [Time frame: Baseline vs. up to 5 months]
  • Change from baseline in Perceived Stress Scale at up to 3 months [Time frame: Baseline to up to 3 months]
  • Change from up to 3 months in Perceived Stress Scale at up to 5 months. [Time frame: Up to 3 months vs. up to 5 months]
  • Change from baseline in Perceived Stress Scale at up to 5 months. [Time frame: Baseline to up to 5 months]
  • Change from baseline in Cognitive Insight Scale at up to 3 months [Time frame: Baseline vs. up to 3 months]
  • Change from up to 3 months in Cognitive Insight Scale at up to 5 months. [Time frame: Up to 3 months vs. up to 5 months]
  • Change from baseline in Cognitive Insight Scale at up to 5 months. [Time frame: Baseline vs. up to 5 months]
  • Change from baseline in Defeatist Performance Attitudes at up to 3 months [Time frame: Baseline vs. Up to 3 months]
  • Change from up to 3 months in Defeatist Performance Attitudes at up to 5 months. [Time frame: Up to 3 months vs up to 5 months]
  • Change from baseline in Defeatist Performance Attitudes at up to 5 months. [Time frame: Baseline vs. up to 5 months]

Eligibility criteria

Participant Inclusion Criteria:

  • 13-18 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

Participation Exclusion Criteria:

  • Group member meeting criteria for a current/past psychotic disorder

Inclusion Criteria for Parents or Legal Guardians:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Bellefield Towers — Pittsburgh

Publications

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. PMID 6668417
  • Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0. PMID 15099613
  • Cane, D.B. Olinger, L.J,. Gotlib, I.H., Kuiper, N.A. (1986) Factor structure of the Dysfunctional Attitude Scale in a student population. J Clin Psychol. 42, 307 - 309 .
  • Benedict, R. H. B., Schretlen, D., Groninger, L., & Brandt, J. (1998). The Hopkins verbal learning test-revised: Normative data and analysis of interform and test-retest reliability. Clinical Neuropsychologist, 12, 43-55.
  • Keefe RS, Goldberg TE, Harvey PD, Gold JM, Poe MP, Coughenour L. The Brief Assessment of Cognition in Schizophrenia: reliability, sensitivity, and comparison with a standard neurocognitive battery. Schizophr Res. 2004 Jun 1;68(2-3):283-97. doi: 10.1016/j.schres.2003.09.011. PMID 15099610
  • Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93. PMID 18557686
  • Cornblatt BA, Auther AM, Niendam T, Smith CW, Zinberg J, Bearden CE, Cannon TD. Preliminary findings for two new measures of social and role functioning in the prodromal phase of schizophrenia. Schizophr Bull. 2007 May;33(3):688-702. doi: 10.1093/schbul/sbm029. Epub 2007 Apr 17. PMID 17440198
  • Lee, R. M., & Robbins, S. B. (1995). Measuring belongingness: The Social Connectedness and the Social Assurance Scales. Journal of Counseling Psychology, 42, 232-241.

Identifiers

NCT: NCT05398120 · STUDY21120012 · 1 H79 SM081196-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗