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Technology Enhanced Family Treatment

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ClinicalTrials.gov Identifier: NCT03913013
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
David J. Miklowitz, Ph.D., University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Mood Disorders Bipolar Disorder Major Depression Behavioral: Family-Focused Treatment with MCC App Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: The Outcomes assessor will be unaware of whether the patient is in FFT-MCC or FFT-Assess.
Primary Purpose: Treatment
Official Title: Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 14, 2021
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders

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.
Behavioral: 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.

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.
Behavioral: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913013


Contacts
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Contact: David J Miklowitz, Ph.D. 310-267-2659 dmiklowitz@mednet.ucla.edu
Contact: Danielle Denenny, Ph.D. 310-825-8740 DDenenny@mednet.ucla.edu

Locations
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United States, California
UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine Recruiting
Los Angeles, California, United States, 90024-1759
Contact: David J Miklowitz, PhD    310-267-2659    dmiklowitz@mednet.ucla.edu   
Principal Investigator: David J Miklowitz, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Armen Arevian, MD University of California, Los Angeles
Principal Investigator: David J Miklowitz, PhD University of California, Los Angeles

Additional Information:
Publications:
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Responsible Party: David J. Miklowitz, Ph.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03913013     History of Changes
Other Study ID Numbers: IRB#18-000906
R34MH117200 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: One year following completion of the trial.
Access Criteria: Meta-analyses

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David J. Miklowitz, Ph.D., University of California, Los Angeles:
Family Therapy

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Depressive Disorder, Major
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Depressive Disorder