跳至主要内容
临床试验/NCT03913013
NCT03913013已完成1 期

Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
65
试验地点
2
主要终点
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation

研究概览

简要总结

The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). In adolescents with mood instability who have a parent with bipolar or major depressive disorder, clinicians in community clinics will conduct FFT sessions (consisting of psychoeducation and family skills training) supplemented by weekly MCC "real time" assessments of moods and family relationships; based on results of these assessments and the family's progress in treatment, clinicians will then push personalized informational and coaching alerts regarding the practice of communication and problem-solving skills. The investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective than FFT without coaching/informational alerts in altering treatment targets and in stabilizing youths' mood symptoms and quality of life.

详细描述

The investigative group has shown in several randomized trials that family-focused therapy (FFT) for symptomatic youth at high-risk for bipolar disorder - consisting of psychoeducation and family communication and problem solving skills training - is an effective adjunct to pharmacotherapy in hastening symptomatic recovery. However, between 50%-60% of high-risk youth still have residual mood symptoms and functional impairment after 18 weeks of FFT. In prior studies, two constructs have emerged as predictors of lack of response to treatment: mood instability in the child and expressed emotion (EE) in parents (i.e., frequent critical comments or hostility). In adolescents (ages 12-18) with a parent with bipolar disorder or major depressive disorder, the investigators hypothesize that augmenting FFT with frequent and targeted interventions in the home setting through a Smartphone app (MyCoachConnect, or MCC) will (a) have a greater and more rapid impact than standard FFT on the targeted mechanisms of mood instability in adolescents and EE in parents, and (b) as a result, enhance symptom resolution and functioning in adolescents. To be eligible, adolescents must score high on parent-rated measures of mood instability, and have at least one parent who is high-EE by speech sample coding criteria. The MCC app will record weekly open speech samples from parents and children and daily and weekly mood ratings from adolescents. The app assessments will be fed back to the FFT clinician, who will use this information to "push" recommendations for mood regulation, communication, and problem-solving strategies (linked to the FFT modules) for parents and youth. In year 1, the investigators will conduct an open trial (n=25) to determine (a) the feasibility and acceptability of FFT with mobile coaching (FFT-MCC), as given by clinicians in community settings, and (b) associations between online/speech feature proxies of the targets (mood instability and EE as measured weekly by MCC) and standard measures of the targets. In years 2 and 3 the investigators will conduct a 60-case randomized clinical trial in which families are assigned to FFT with MCC skills coaching or FFT with MCC assessments only, with no skills coaching. The primary hypotheses are that FFT-MCC will be acceptable to parents, adolescents and clinicians, and more effective than FFT without MCC coaching in engaging the targets of mood instability and EE and promoting improvements in adolescents' mood symptoms and quality of life over 27 weeks. The study will facilitate the translation of a technological augmentation to an evidence-based family intervention, with the goal of increasing treatment access among families with mood disorders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The Outcomes assessor will be unaware of whether the patient is in FFT-MCC or FFT-Assess.

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • English speaking and has access to smart-phones, a tablet, or computer
  • Age 13-19 years old
  • One parent with diagnosis of bipolar disorder type I, bipolar disorder type II, or
  • major depressive disorder.
  • At least one parent is rated high in perceived criticism of the child.
  • Child shows evidence of mood instability
  • Child is not currently in individual therapy.

排除标准

  • Over 6 on the Autism Spectrum Disorder screener
  • a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition manic episode of bipolar I disorder has occurred in the past 2 weeks
  • history of persistent psychotic symptoms that have not remitted when mood states remit.
  • intelligence quotient below 70 from school records
  • Any significant and persistent substance or alcohol abuse in the prior 3 months
  • Previously received a full course (i.e., 10-12 sessions) of FFT
  • Current, active sexual abuse, physical abuse, or domestic violence.

结局指标

主要结局

Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation

时间窗: 27 weeks (average rating across this time period)

Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of weekly depressive symptom fluctuation based on an interview with the child and parent (or parent unit). The primary outcome variable for this study is the average of the ALIFE weekly consensus ratings. For the ALIFE, an independent evaluator rates the child's level of depression each week for 27 weeks on a Psychiatric Status Rating (PSR) scale ranging from 1 (asymptomatic) to 6 (extremely symptomatic). Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder) and scores of 1-2 are considered remitted. For each of 27 weeks the evaluator provides a separate rating based on the child interview and parent interview and then calculates a weekly consensus rating per ALIFE developer guidelines.

次要结局

  • Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.(weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.)
  • Expressed Emotion in Parents From the Five Minute Speech Sample(Count of participants with primary parent rated high in expressed emotion at 27 weeks.)
  • Children's Global Assessment of Functioning(Means are reported at 27 weeks (study endpoint))
  • Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)(Outcomes scores at 27 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David J. Miklowitz, Ph.D.

Principal Investigator

University of California, Los Angeles

研究点 (2)

Loading locations...

相似试验