Testing the Feasibility of a Skills Group for Adolescents and Young Adults at Clinical High-risk for Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Attrition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
There is one condition so masking is not relevant
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Skills Group
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.
干预措施: Skills Group (Behavioral)
结局指标
主要结局
Attrition
时间窗: Up to 5 months
Feasibility measure; this will be assessed by recording the number of individuals that discontinued group participation.
Attendance
时间窗: Up to 5 months
Feasibility measure; daily attendance will be recorded.
Modified Quick Lecomte and Leclerc Scale
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Change from baseline in Perceived Stress Scale at up to 5 months.(Baseline to up to 5 months)
- Change from baseline in Cognitive Insight Scale at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Cognitive Insight Scale at up to 5 months.(Up to 3 months vs. up to 5 months)
- Change from baseline in Cognitive Insight Scale at up to 5 months.(Baseline vs. up to 5 months)
- Change from baseline in Defeatist Performance Attitudes at up to 3 months(Baseline vs. Up to 3 months)
- Change from up to 3 months in Defeatist Performance Attitudes at up to 5 months.(Up to 3 months vs up to 5 months)
- Change from baseline in Defeatist Performance Attitudes at up to 5 months.(Baseline vs. up to 5 months)
- Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Avoidance Fusion Questionnaire for Youth at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Avoidance Fusion Questionnaire for Youth at up to 5 months(Baseline vs. up to 5 months)
- Change from baseline in Social and Role Functioning Scale at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Social and Role Functioning Scale at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Social and Role Functioning Scale at up to 5 months(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(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(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(Baseline vs. up to 5 months)
- Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Negative Symptom Inventory Psychosis-Risk at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Negative Symptom Inventory Psychosis-Risk at up to 5 months(Baseline vs. up to 5 months)
- Change from baseline in Beck Depression Inventory to up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Beck Depression Inventory to up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Beck Depression Inventory to up to 5 months(Baseline vs. up to 5 months)
- Change from baseline in Beck Anxiety Inventory at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Beck Anxiety Inventory at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Beck Anxiety Inventory at up to 5 months(Baseline vs. up to 5 months)
- Child Trauma Questionnaire(Baseline)
- Change from baseline Child and Adolescent Mindfulness Measure at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months Child and Adolescent Mindfulness Measure at up to 5 months(up to 3 months vs. up to 5 months)
- Change from baseline Child and Adolescent Mindfulness Measure at up to 5 months(Baseline vs. up to 5 months)
- Change from baseline in Emotion Regulation Questionnaire at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Emotion Regulation Questionnaire at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Emotion Regulation Questionnaire at up to 5 months(Baseline vs. up to 5 months)
- Change from baseline in Social Connectedness Scale at up to 3 months(Baseline vs. up to 3 months)
- Change from up to 3 months in Social Connectedness Scale at up to 5 months(Up to 3 months vs. up to 5 months)
- Change from baseline in Social Connectedness Scale at up to 5 months(Baseline vs. up to 5 months)
- Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 3 months(Baseline vs. up to 3 months)
- Change in Internalized Stigma Mental Illness Inventory (ISMI) from up to 3 months to up to 5 months(Up to 3 months vs. up to 5 months)
- Change in Internalized Stigma Mental Illness Inventory (ISMI) baseline up to 5 months(Baseline vs. up to 5 months)
研究者
Leslie Horton
Assistant Professor
University of Pittsburgh