- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913013
Technology Enhanced Family Treatment
October 7, 2022 updated by: David J. Miklowitz, Ph.D., University of California, Los Angeles
Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90024-1759
- UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
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Active Comparator: 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.
|
12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average mood symptom scores over 27 weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Time Frame: 27 weeks, with ratings done by an independent evaluator each week
|
Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of mood disorder fluctuation based on an interview with the child and at least one parent.
ALIFE Psychiatric Status Ratings range from 1 (asymptomatic) to 6 (extremely symptomatic) and are made weekly for depression, mania, hypomania, delusions, hallucinations, and suicidal ideation.
Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder or manic episode) and scores of 1-2 are considered remitted.
|
27 weeks, with ratings done by an independent evaluator each week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood instability, as rated by parents and children using the Children's Affective Lability Scale (CALS) and the Parent-Rated General Behavior Inventory
Time Frame: Mean Children's Affective Lability scores computed at baseline and every 9 weeks for 27 weeks
|
Changes in mood states from sadness to irritability to elation or other moods.
The CALS is a 20-item survey completed by parents.
In this study, a score of 20 will be used to indicate high mood instability.
Parent ratings on the Parent General Behavior Inventory, 10 item Mania scale will be made at study entry, with a score of 6 or higher indicating mood instability.
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Mean Children's Affective Lability scores computed at baseline and every 9 weeks for 27 weeks
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Expressed emotion in parents from the Five Minute Speech Sample
Time Frame: Ratings of high vs. low expressed emotion in each parent obtained at baseline and every 9 weeks for 27 weeks.
|
Parental expressed emotion is a measure of critical comments, hostility, or emotional overinvolvement.
The primary instrument in this study is the Five Minute Speech Sample, which is scored by an independent evaluator on number of criticisms, presence/absence of hostility, or overinvolvement.
One critical comment or a rating of present for hostility or overinvolvement means the parent is rated high in expressed emotion, and low expressed emotion otherwise.
Expressed emotion is also measured by the Perceived Criticism Scale, a 1-10 measure of how often the child thinks each parent criticizes him/her.
A rating of '5' is considered high and indicative of a high EE parent/offspring relationship.
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Ratings of high vs. low expressed emotion in each parent obtained at baseline and every 9 weeks for 27 weeks.
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Free speech samples coded using the Linguistic Inquiry Word Count system.
Time Frame: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
|
Callers are asked to speak for 3-5 minutes about how they are doing and whether anything has gone well or whether they have had difficulties.
The samples will be transcribed and coded via the Linguistic Inquiry Word Count.
The goal is to measure whether mood instability and expressed emotion can be captured from weekly free speech call-ins by parents or youth.
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weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Armen Arevian, MD, University of California, Los Angeles
- Principal Investigator: David J Miklowitz, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2018
Primary Completion (Actual)
October 20, 2021
Study Completion (Actual)
October 20, 2021
Study Registration Dates
First Submitted
April 9, 2019
First Submitted That Met QC Criteria
April 10, 2019
First Posted (Actual)
April 12, 2019
Study Record Updates
Last Update Posted (Actual)
October 12, 2022
Last Update Submitted That Met QC Criteria
October 7, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#18-000906
- R34MH117200 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The investigators will submit digital files to the NIH Freedom of Information Office Coordinator containing all raw data, variable coding information, and copies of measures.
The investigators will share the data with other investigators through the National Database for Clinical Trials Related to Mental Illness.
IPD Sharing Time Frame
One year following completion of the trial.
IPD Sharing Access Criteria
Meta-analyses
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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