Technology Enhanced Family Treatment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-15

Study Completion Date

2021-10-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mood Disorders Bipolar Disorder Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigation is comparing youth who receive family-focused treatment with the MyCoachConnect (FFT-MCC) mobile application (assessments, skill training, psychoeducation) to youth who receive FFT plus only the assessment components of the MCC app (FFT-Assess) on symptomatic outcome and family functioning over 27 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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FFT with MCC App (FFT-MCC)

Youth in this study arm will receive 12 sessions of FFT (psychoeducation, communication skills training, and problem-solving skills training) with their parents and siblings. They and their parents will make regular mobile app ratings of mood, sleep, family functioning, stress, and perceived criticism. Children and parents will call into a voice-activated phone system and be asked to speak freely for 3-5 minutes about their health and family functioning. They will be guided through 12 lesson plans in which they practice skills such as active listening or identifying prodromal signs of episodes, paralleling what they are learning in sessions. The clinician will be able to set a weekly skill training assignment and observe the family's practice of the skill between sessions. They will adapt session content accordingly.

Group Type EXPERIMENTAL

Family-Focused Treatment with MCC App

Intervention Type BEHAVIORAL

12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.

FFT with App Assessments only (FFT-Assess)

Youth in this condition will receive the same 12 sessions of FFT, but the app will be limited to daily and weekly assessments of their mood, sleep, stress, and family functioning. The app will not provide the skill training offered in the FFT-MCC condition.

Group Type ACTIVE_COMPARATOR

Family-Focused Treatment with MCC App

Intervention Type BEHAVIORAL

12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.

Interventions

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Family-Focused Treatment with MCC App

12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No