Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial

针对精神病临床高风险个体的以家庭为中心的治疗：一项验证性疗效试验

• 批准号: 10256074
• 负责人: CARRIE E BEARDEN
• 金额: $ 170.5万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-07 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10256074
• 关键词: Achievement; Acute; Adolescence; Adolescent; Adolescent and Young Adult; Aftercare; Age; American; Attenuated; Behavior; Behavioral; Bipolar Disorder; Car Phone; Caring; Case Management; Clinical; Communication; Conflict (Psychology); Deterioration; Development; Diagnostic; Disease remission; Distal; Early Intervention; Education; Emotional; Enrollment; Evidence based intervention; Family; Family Relationship; Family Study; Functional disorder; Individual; Intervention; Interview; Laboratories; Longitudinal Studies; Measurement; Measures; Mediating; Mental disorders; Methodology; Moods; Outcome; Parents; Participant; Patients; Perception; Persons; Population; Problem Solving; Psychoses; Psychotic Disorders; Questionnaires; Randomized; Randomized Clinical Trials; Research; Risk; Sampling; Severities; Site; Social Functioning; Structure; Symptoms; Syndrome; Testing; Time; Training; Validation; Youth; attenuated psychosis syndrome; base; blind; clinical risk; communication behavior; confirmatory clinical trial; confirmatory trial; disorder later incidence prevention; evidence base; experience; follow-up; functional outcomes; high risk; improved; mobile application; offspring; preventive intervention; primary outcome; proband; psychoeducation; psychosocial; psychotic symptoms; randomized trial; recruit; reduce symptoms; remote monitoring; response; secondary outcome; skills; skills training; social; social engagement; symptom management; therapy design; treatment as usual; young adult

Project Summary This proposal responds to RFA-MH-18-707, “Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01).” Adolescents and young adults at clinical high risk (CHR) for psychosis, characterized by recent onset or worsening of attenuated positive symptoms (APS), have a 16%-30% risk of converting to a psychotic disorder in 2 years. In a prior randomized trial in the North American Prodrome Longitudinal Study (NAPLS) network, we showed that family-focused therapy for clinical high-risk persons (FFT- CHR) was more effective than brief family education in (a) improving family (offspring/parent) communication and (b) reducing APS over 6 months, particularly among CHR youth with high baseline scores on a measure of individual risk of psychosis conversion. Both treatments were associated with reductions in young people's perceptions of criticism from parents, which in turn were associated with decreases in APS over 12 months. These findings led us to hypothesize enhanced family communication as a mechanism of action of FFT-CHR. FFT-CHR consists of 18 sessions in 6 months of psychoeducation, communication training, and problem-solving skills training. In the present study conducted in 7 NAPLS sites, we will randomly assign 220 CHR individuals (ages 13-25) and their parent(s) to FFT-CHR or a 6-month Enhanced Care (EC) treatment, consisting of 3 family educational sessions followed by 5 months of individual support and case management. CHR individuals will be interviewed and fill out questionnaires regarding APS (primary outcome) and social functioning (secondary) every 6 months over 18 months. We will examine behavioral targets indicative of improved family relationships: reductions in proportion of critical-conflictual statements and increases in proportion of calm-constructive statements of parents and CHR offspring in laboratory family interactional assessments conducted at baseline and end of treatment (6 months). We will also capture granular changes in targets and outcomes through remote monitoring: CHR participants in both conditions will enroll in a newly developed mobile phone app to facilitate weekly proband ratings of perceived criticism, appraisals of family interactions, and primary and secondary outcomes. We hypothesize that (1) youth/young adults in FFT-CHR will show greater improvements in APS than those in EC in 6 months; (2) improvements in parent and offspring communication by 6 months will be associated with downstream improvements in APS and social functioning over 18 months; and improvements in parent and offspring communication by 6 months will mediate the relationship between treatment condition and changes in primary and secondary outcomes over 18 months. We hypothesize that individuals who are at higher baseline risk of psychosis conversion will show more improvement in targets and primary and secondary outcomes in FFT-CHR than EC, compared to those at lower conversion risk. The involvement of 7 collaborative NAPLS sites with complementary expertise will assure accelerated recruitment of the sample, diagnostic reliability, sample diversity, and treatment exportability.

项目概要 该提案回应 RFA-MH-18-707，“非药理学的确认功效临床试验” 精神障碍干预措施（R01）。”精神病临床高风险（CHR）的青少年和年轻人， 以最近出现或恶化的减弱阳性症状 (APS) 为特征，有 16%-30% 的风险 在之前的北美前驱症状随机试验中，患者在 2 年内转变为精神障碍。 纵向研究（NAPLS）网络，我们表明针对临床高危人群的以家庭为中心的治疗（FFT- CHR）在 (a) 改善家庭（子女/父母）沟通方面比简短的家庭教育更有效 (b) 在 6 个月内减少 APS，特别是在基线得分较高的 CHR 青少年中 两种治疗方法均与年轻人精神病转化的个体风险降低有关。 对父母批评的看法，这反过来又与 12 个月内 APS 的下降有关。 这些发现促使我们将增强家庭沟通作为 FFT-CHR 的作用机制。 FFT-CHR 包括为期 6 个月的 18 节心理教育、沟通训练和问题解决课程 在 7 个 NAPLS 站点进行的本研究中，我们将随机分配 220 名 CHR 人员。 （13-25 岁）及其父母接受 FFT-CHR 或为期 6 个月的强化护理 (EC) 治疗，由 3 个家庭组成 教育课程之后将进行 5 个月的个人支持和案例管理。 接受采访并填写有关 APS（主要结果）和社会功能（次要）的调查问卷 我们将在 18 个月内每 6 个月检查一次表明改善家庭关系的行为目标： 减少批评性冲突言论的比例，增加冷静建设性言论的比例 基线时进行的实验室家庭互动评估中父母和 CHR 后代的陈述 我们还将通过远程捕获目标和结果的细微变化。 监控：两种情况下的 CHR 参与者都将注册新开发的手机应用程序，以方便 每周先证者对感知批评的评分、对家庭互动的评估以及小学和中学 我们追求 (1) FFT-CHR 中的青少年/年轻人在 APS 方面将表现出比 FFT-CHR 更大的进步。 6 个月内的 EC ；(2) 6 个月内父母和后代的沟通将得到改善 18 个月内 APS 和社会功能的下游改善以及家长和家长的改善； 6个月时的后代交流将调节治疗条件和变化之间的关系 我们追踪了 18 个月内处于较高基线的个体。 精神病转变的风险将在目标和主要和次要结果方面显示出更大的改善 FFT-CHR 与 EC 相比，转换风险较低 7 个协作 NAPLS 站点的参与。 具有互补的专业知识将确保加速样本招募、诊断可靠性、样本 多样性和治疗可输出性。