Clinical High-RiskNCT05398120
Skills Group for Youth at Clinical High-Risk for Psychosis
A study testing Skills Group in people with Clinical High-Risk and Psychological, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Clinical High-Risk, Psychological
- What is being tested?
- Skills Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bellefield Towers
Pittsburgh, Pennsylvania, 15213
Tina Gupta, MA, 412-246-5845, guptat3@upmc.edu
Leslie Horton, PHD
About this study
Official title: Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis
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.
Read the 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.
- Conditions
- Clinical High-Risk, Psychological
- Being tested
- Skills Group
- Keywords
- Group intervention, Dialectical behavioral therapy skills, Cognitive behavioral therapy skills, Psychosis-risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills GroupBehavioural
Also called Psychosis-risk 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Skills Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.
Measured: Up to 5 months
Attendance
Feasibility measure; daily attendance will be recorded.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Up to 5 months
Secondary outcomes (43)
Change from baseline in Lehman Quality of Life Functional Assessment at up to 3 months.
A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Lehman Quality of Life Functional Assessment at up to 5 months.
A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Lehman Quality of Life Functional Assessment at up to 5 months.
A brief 4- item questionnaire that asks about general feelings about one's life, the amount of fun in life, feeling towards others, and amount of time spent with others on a scale of 0 (terrible) to 6 (delightful) scale. Scores range from 0-24, with lower scores indicating lower quality of life. ~2 minutes
Measured: Baseline vs. up to 5 months
Change from baseline in Perceived Stress Scale at up to 3 months
A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Some items are reversed scored. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.
Measured: Baseline to up to 3 months
Change from up to 3 months in Perceived Stress Scale at up to 5 months.
A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Perceived Stress Scale at up to 5 months.
A 10-item questionnaire that measures the degree to which situations in one's life are appraised as stressful. Items were designed to assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Ratings are collected on a 0 ("never") to 4 ("very often") scale with higher scores indicating more perceived stress, range is 0-40.
Measured: Baseline to up to 5 months
Change from baseline in Cognitive Insight Scale at up to 3 months
A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Cognitive Insight Scale at up to 5 months.
A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Cognitive Insight Scale at up to 5 months.
A 15-item measure evaluating patient's self-reflectiveness and their overconfidence in their interpretations of their experiences. Ratings are collected on a 0 "do not agree at all" to 3 "agree completely" scale ranging from 0-45. A 9-item self-reflectiveness subscale (range 0-27) and a 6-item self-certainty subscale (range 0-18) are also made. Higher scores indicate more insight, self-reflectiveness, and more self-certainty. A composite index of the insight reflecting cognitive insight is calculated by subtracting the score for the self-certainty scale from that of the self-reflectiveness scale where lower numbers indicate less insight.
Measured: Baseline vs. up to 5 months
Change from baseline in Defeatist Performance Attitudes at up to 3 months
A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.
Measured: Baseline vs. Up to 3 months
Change from up to 3 months in Defeatist Performance Attitudes at up to 5 months.
A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.
Measured: Up to 3 months vs up to 5 months
Change from baseline in Defeatist Performance Attitudes at up to 5 months.
A 15-item questionnaire assessing dysfunctional attitudes commonly targeted by CBT therapy. Items are rated on a 1-7 Likert scale and higher total scores (range = 15-105) indicate more severe defeatist performance attitudes.
Measured: Baseline vs. up to 5 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months
17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Avoidance Fusion Questionnaire for Youth at up to 5 months
17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 5 months
17 items assessing psychological acceptance on a 1 (not at all true) to 5 (very true) scale. Sum scores can range from 17-85 with higher scores representing more psychological inflexibility.
Measured: Baseline vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 3 months
A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Social and Role Functioning Scale at up to 5 months
A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 5 months
A brief interview assessing social and role areas of functioning not confounded by symptom ratings and appropriate across life spans; high scores indicate better social functioning. Scores fall on a 1-10 scale.
Measured: Baseline vs. up to 5 months
Change in symptoms from baseline Structured Interview for Psychosis-Risk Syndromes and/or Mini interview (abbreviated version) to up to 3 months
An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.
Measured: Baseline vs. up to 3 months
Change from up to 3 months on the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months
An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months
An interview designed to assess five domains of positive symptoms (e.g., seeing shadows). Ratings are given by assessors on a 0 (absent) to 6 (severe) scale. Higher ratings indicate more symptom severity. Scores range from 0-30.
Measured: Baseline vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 3 months
A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Negative Symptom Inventory Psychosis-Risk at up to 5 months
A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 5 months
A brief, 11-item assessment of negative symptoms, with higher scores indicating more negative symptoms. Two items assess avolition (i.e., reduced motivational behavior and experience), three items assess asociality (i.e., reduction in the desire for and engagement in social activities), two items assess anhedonia (i.e., reduction in pleasure in activities), three items related to affect, and 1 related to quantity of speech. Each of these subscales are summed and/or averaged and there is a total score (range is 0-55) with higher scores indicating more negative symptom severity.
Measured: Baseline vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 3 months
A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Beck Depression Inventory to up to 5 months
A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 5 months
A 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a 4 point likert scale with higher scores indicating more depressive symptoms, range 0-63.
Measured: Baseline vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 3 months
A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Beck Anxiety Inventory at up to 5 months
A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 5 months
A 21-item scale measuring common symptoms of anxiety on a 4 point likert scale with higher scores indicating more anxiety, range 0-63.
Measured: Baseline vs. up to 5 months
Child Trauma Questionnaire
A 28-item screen designed to assess the degree to which different traumatic experiences apply to the individual (e.g., never true (1), rarely (2), sometimes true (3), often true (4), very often true (5)). Higher total scores indicate more traumatic events and scores can range from 28-140. Some items are reverse scored. This questionnaire also measures subscales that have five items each: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each subscale ranges from 5-25 with higher scores indicating more trauma exposure.
Measured: Baseline
Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months
A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.
Measured: Baseline vs. up to 3 months
Change from up to 3 months Child and Adolescent Mindfulness Measure at up to 5 months
A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.
Measured: up to 3 months vs. up to 5 months
Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months
A 10 item measure that assesses present-moment awareness and nonjudgmental, nonavoidant responses to thoughts and feelings. Ratings are collected on a 0 (never true) to 4 (always true) and are reverse scored. Scores range from 0-40. Higher scores indicate higher levels of mindfulness.
Measured: Baseline vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 3 months
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Emotion Regulation Questionnaire at up to 5 months
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 5 months
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree), and higher scores indicate more use of the noted strategies. Cognitive reappraisal (six items, range 6-42) and expressive suppression items (four items, range 4-28).
Measured: Baseline vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 3 months
A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.
Measured: Baseline vs. up to 3 months
Change from up to 3 months in Social Connectedness Scale at up to 5 months
A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.
Measured: Up to 3 months vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 5 months
A 20-item measure to assess how connected one feels to others in their social environment on a 1 (strongly disagree to 6 (strongly agree) scale. All of the items are reversed and are then summed for a total score. A high score reflects more connectedness, range is 20-120.
Measured: Baseline vs. up to 5 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 3 months
A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.
Measured: Baseline vs. up to 3 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) from up to 3 months to up to 5 months
A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.
Measured: Up to 3 months vs. up to 5 months
Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 5 months
A 29 item measure that assesses self-stigma on a 1 (strong disagree) - 4 (strongly agree) scale. Scores can range from 29-116 with higher scores indicating more self-stigma. Subscales include alienation, stereotype endorsement, perceived discrimination, social withdrawal, and stigma resistance.
Measured: Baseline vs. up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start26 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Clinical High-RiskStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Responsible party
- Principal investigator, Leslie Horton, University of Pittsburgh
- Investigators
- Leslie Horton, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398120
- Sponsor's protocol ID
- STUDY21120012
- Other IDs
- 1 H79 SM081196-01
- Status last verified
- Feb 2026
- First submitted
- 15 May 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD underlying publication will be shared including data dictionaries after publication and in line with the grantee policies regarding data sharing. Data will be de-identified before sharing.
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.
PubMed 6668417Beck 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.
PubMed 15099613Cane, 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.
PubMed 15099610Greco 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.
PubMed 18557686Cornblatt 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.
PubMed 17440198Lee, R. M., & Robbins, S. B. (1995). Measuring belongingness: The Social Connectedness and the Social Assurance Scales. Journal of Counseling Psychology, 42, 232-241.
Miller TJ, McGlashan TH, Woods SW, Stein K, Driesen N, Corcoran CM, Hoffman R, Davidson L. Symptom assessment in schizophrenic prodromal states. Psychiatr Q. 1999 Winter;70(4):273-87. doi: 10.1023/a:1022034115078.
PubMed 10587984Loewy RL, Pearson R, Vinogradov S, Bearden CE, Cannon TD. Psychosis risk screening with the Prodromal Questionnaire--brief version (PQ-B). Schizophr Res. 2011 Jun;129(1):42-6. doi: 10.1016/j.schres.2011.03.029. Epub 2011 Apr 20.
PubMed 21511440McGlashan, T. H., Walsh, B. C., Woods, S. W., Addington, J., Cadenhead, K., Cannon, T., & Walker, E. (2001). Structured interview for psychosis-risk syndromes. New Haven, CT: Yale School of Medicine.
Pelletier-Baldelli A, Strauss GP, Visser KH, Mittal VA. Initial development and preliminary psychometric properties of the Prodromal Inventory of Negative Symptoms (PINS). Schizophr Res. 2017 Nov;189:43-49. doi: 10.1016/j.schres.2017.01.055. Epub 2017 Feb 8.
PubMed 28189529BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Kenardy JA, Spence SH, Macleod AC. Screening for posttraumatic stress disorder in children after accidental injury. Pediatrics. 2006 Sep;118(3):1002-9. doi: 10.1542/peds.2006-0406.
PubMed 16950991
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis
- ClinicalTrials.gov ID
- NCT05398120
- Acronym / sponsor ID
- STUDY21120012
- Conditions
- Clinical High-Risk, Psychological
- Keywords
- Group intervention, Dialectical behavioral therapy skills, Cognitive behavioral therapy skills, Psychosis-risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Skills Group | Experimental | Behavioral: Skills GroupThere 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills GroupAlso: Psychosis-risk skills groupAdolescents 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. | Behavioural | Skills Group |
Primary outcome
Attrition
Time frame: Up to 5 months
Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.
Attendance
Time frame: Up to 5 months
Feasibility measure; daily attendance will be recorded.
Modified Quick Lecomte and Leclerc Scale
Time frame: Up to 5 months
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.
Participation Scale
Time frame: Up to 5 months
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.
Change from baseline in the participant group survey at up to 3 months
Time frame: Baseline vs. 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.
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
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.
Change from baseline in the participant group survey at up to 5 months
Time frame: Baseline vs. 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.
Change from baseline in Satisfaction with Therapy and Therapist Scale at up to 3 months
Time frame: Baseline vs. 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).
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.
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).
Fidelity scores
Time frame: Up to 5 months
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.
43 secondary outcomes
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
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Avoidance Fusion Questionnaire for Youth at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Social and Role Functioning Scale at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Social and Role Functioning Scale at up to 5 months
Time frame: Baseline vs. up to 5 months
Change in symptoms from baseline Structured Interview for Psychosis-Risk Syndromes and/or Mini interview (abbreviated version) to up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months on the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in the Structured Interview for Psychosis-Risk Syndromes interview and/or Mini interview (abbreviated version) at up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Negative Symptom Inventory Psychosis-Risk at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Beck Depression Inventory to up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Beck Depression Inventory to up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Beck Anxiety Inventory at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Beck Anxiety Inventory at up to 5 months
Time frame: Baseline vs. up to 5 months
Child Trauma Questionnaire
Time frame: Baseline
Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months Child and Adolescent Mindfulness Measure at up to 5 months
Time frame: up to 3 months vs. up to 5 months
Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Emotion Regulation Questionnaire at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Emotion Regulation Questionnaire at up to 5 months
Time frame: Baseline vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 3 months
Time frame: Baseline vs. up to 3 months
Change from up to 3 months in Social Connectedness Scale at up to 5 months
Time frame: Up to 3 months vs. up to 5 months
Change from baseline in Social Connectedness Scale at up to 5 months
Time frame: Baseline vs. up to 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 15099613Beck 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.
- BackgroundCane, 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 .
- BackgroundBenedict, 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.
- Background: PubMed 15099610Keefe 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.
- Background: PubMed 18557686Greco 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.
- Background: PubMed 17440198Cornblatt 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.
- BackgroundLee, R. M., & Robbins, S. B. (1995). Measuring belongingness: The Social Connectedness and the Social Assurance Scales. Journal of Counseling Psychology, 42, 232-241.
- Background: PubMed 10587984Miller TJ, McGlashan TH, Woods SW, Stein K, Driesen N, Corcoran CM, Hoffman R, Davidson L. Symptom assessment in schizophrenic prodromal states. Psychiatr Q. 1999 Winter;70(4):273-87. doi: 10.1023/a:1022034115078.
- Background: PubMed 21511440Loewy RL, Pearson R, Vinogradov S, Bearden CE, Cannon TD. Psychosis risk screening with the Prodromal Questionnaire--brief version (PQ-B). Schizophr Res. 2011 Jun;129(1):42-6. doi: 10.1016/j.schres.2011.03.029. Epub 2011 Apr 20.
- BackgroundMcGlashan, T. H., Walsh, B. C., Woods, S. W., Addington, J., Cadenhead, K., Cannon, T., & Walker, E. (2001). Structured interview for psychosis-risk syndromes. New Haven, CT: Yale School of Medicine.
- Background: PubMed 28189529Pelletier-Baldelli A, Strauss GP, Visser KH, Mittal VA. Initial development and preliminary psychometric properties of the Prodromal Inventory of Negative Symptoms (PINS). Schizophr Res. 2017 Nov;189:43-49. doi: 10.1016/j.schres.2017.01.055. Epub 2017 Feb 8.
- Individual participant dataSharing planned: Yes. All IPD underlying publication will be shared including data dictionaries after publication and in line with the grantee policies regarding data sharing. Data will be de-identified before sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leslie Horton, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skills Group in people with Clinical High-Risk and Psychological, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina Gupta, PHD (412-246-5845, guptat3@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition (time frame: Up to 5 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398120, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.