Skills Group for Youth at Clinical High-Risk for Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Skills Group
BehavioralAdolescents 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Skills GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Attrition
Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.
Time frame
Up to 5 months2
Attendance
Feasibility measure; daily attendance will be recorded.
Time frame
Up to 5 months3
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.
Time frame
Up to 5 months4
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.
Time frame
Up to 5 monthsSecondary outcomes
1
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
Time frame
Baseline vs. up to 3 months2
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
Time frame
Up to 3 months vs. up to 5 months3
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
Time frame
Baseline vs. up to 5 months4
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.
Time frame
Baseline to up to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Substance Abuse and Mental Health Services Administration (SAMHSA)
Collaborator
Source ClinicalTrials.gov