Technology Enhanced Family Treatment

NCT03913013 | Completed Phase 1 Results DMC

• 2 other identifiers: IRB#18-000906R34MH117200
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mood Disorders; Bipolar Disorder; Major Depression

Keywords

Family Therapy

Outcome Measures

Primary Outcomes (1)

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

  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.

  27 weeks (average rating across this time period)

Secondary Outcomes (4)

• Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)

  Outcomes scores at 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.

• 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.

• Children's Global Assessment of Functioning

  Means are reported at 27 weeks (study endpoint)

Study Arms (2)

FFT with MCC App (FFT-MCC)

EXPERIMENTAL

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.

Behavioral: Family-Focused Treatment with MCC App

FFT with App Assessments only (FFT-Assess)

ACTIVE COMPARATOR

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.

Behavioral: Family-Focused Treatment with MCC App

Interventions

Family-Focused Treatment with MCC App 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); FFT with MCC App (FFT-MCC)

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine

Los Angeles, California, 90024-1759, United States

Location

Related Publications (5)

• Miklowitz DJ, Chung B. Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Fam Process. 2016 Sep;55(3):483-99. doi: 10.1111/famp.12237. Epub 2016 Jul 29.

  PMID: 27471058 BACKGROUND

• Miklowitz DJ, Weintraub MJ, Denenny DM, Merranko JA, Hooley JM. Parental expressed emotion, family conflict, and symptom severity in adolescent offspring of parents with mood disorders. J Affect Disord. 2025 Nov 15;389:119620. doi: 10.1016/j.jad.2025.119620. Epub 2025 Jun 9.

  PMID: 40494497 DERIVED

• Miklowitz DJ, Ichinose MC, Weintraub MJ, Merranko JA, Singh MK. Family Conflict, Perceived Criticism, and Aggression in Symptomatic Offspring of Parents With Mood Disorders: Results From a Clinical Trial of Family-Focused Therapy. JAACAP Open. 2024 Feb 28;3(1):73-84. doi: 10.1016/j.jaacop.2024.01.008. eCollection 2025 Mar.

  PMID: 40109484 DERIVED

• Miklowitz DJ, Weintraub MJ, Ichinose MC, Denenny DM, Walshaw PD, Wilkerson CA, Frey SJ, Morgan-Fleming GM, Brown RD, Merranko JA, Arevian AC. A Randomized Clinical Trial of Technology-Enhanced Family-Focused Therapy for Youth in the Early Stages of Mood Disorders. JAACAP Open. 2023 Sep;1(2):93-104. doi: 10.1016/j.jaacop.2023.04.002. Epub 2023 Apr 26.

  PMID: 38094620 DERIVED

• Miklowitz DJ, Weintraub MJ, Posta F, Walshaw PD, Frey SJ, Morgan-Fleming GM, Wilkerson CA, Denenny DM, Arevian AA. Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. J Affect Disord. 2021 Feb 15;281:438-446. doi: 10.1016/j.jad.2020.12.012. Epub 2020 Dec 8.

  PMID: 33360365 DERIVED

Related Links

• UCLA Child and Adolescent Mood Disorders program

MeSH Terms

Conditions

Mood Disorders; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mental Disorders; Bipolar and Related Disorders; Depressive Disorder

Limitations and Caveats

This study illustrates some of the limitations of mobile health interventions for youth with mood disorders. During treatment not all participants completed the weekly app check-ins or utilized the app even when encouraged to do so and provided push reminders. The present study could not evaluate the impact on clinical outcomes of adding mobile apps to standard FFT without a third group of youth who received standard FFT without any app as the comparative condition used an app for surveys.

Results Point of Contact

• Title: David J. Miklowitz, Ph.D., Principal Investigator
• Organization: UCLA Semel Institute for Neuroscience and Behavior

dmiklowitz@mednet.ucla.edu

(310) 267-2659

Study Officials

• Armen Arevian, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• David J Miklowitz, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes assessor will be unaware of whether the patient is in FFT-MCC or FFT-Assess.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 12, 2019
• Study Start: November 15, 2018
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: One year following completion of the trial.
• Access Criteria: Meta-analyses

Locations

US (1)