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

项目摘要 该提案响应了RFA-MH-18-707《非药理学临床试验的确证疗效》 精神障碍干预(R01)。“青少年和青壮年是精神病的临床高危人群， 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 在两年内转变为精神障碍。在北美前驱症状的先前随机试验中 纵向研究(NAPLS)网络，我们表明，针对临床高危人群的家庭重点治疗(FFT- 在(A)改善家庭(子女/父母)沟通方面，CHR)比简单的家庭教育更有效 和(B)在6个月内减少APS，特别是在CHR青年中，在以下方面具有较高的基线分数 精神病转化的个体风险。这两种治疗方法都与减少年轻人的 来自父母的批评的看法，这反过来又与12个月后APS的下降有关。 这些发现使我们假设加强家庭沟通是FFT-CHR的一种作用机制。 FFT-CHR包括18个疗程，为期6个月，包括心理教育、沟通训练和问题解决 技能培训。在目前的研究中，我们将在7个NAPLS站点随机分配220个CHR个体 (13-25岁)及其父母(S)接受FFT-CHR或为期6个月的加强护理(EC)治疗，由3个家庭组成 教育课程，随后是5个月的个人支持和病例管理。CHR个人将被 面谈并填写关于APS(主要结果)和社会功能(次要结果)的问卷 每隔6个月超过18个月。我们将研究表明家庭关系改善的行为目标： 减少批评性-矛盾性声明的比例，增加冷静-建设性的比例 在基线进行的实验室家庭互动评估中父母和CHR后代的陈述 治疗结束(6个月)。我们还将通过远程方式捕获目标和结果的细粒度变化 监控：符合这两种条件的CHR参与者将注册一个新开发的手机应用程序，以方便 每周感受到的批评、对家庭互动的评估以及主要和次要的先证者评级 结果。我们假设(1)青少年/青少年在FFT-CHR中的APS表现出比 6个月后进入欧共体；(2)父母和子女沟通改善6个月将相关 在18个月的时间里，APS和社交功能的下游改善；以及父母和 6个月后的后代交流将调解治疗条件和变化之间的关系 18个月内的主要和次要结果。我们假设处于较高基线的个体 精神病转化的风险将显示出目标以及主要和次要结果的更多改善 FFT-CHR高于EC，与那些转换风险较低的公司相比。参与7个协作性NAPLS站点 具有互补的专业知识将确保加快样本的招募，诊断的可靠性，样本 多样性，以及治疗的可出口性。

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.