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Technology Enhanced Family Treatment

Primary Purpose

Mood Disorders, Bipolar Disorder, Major Depression

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family-Focused Treatment with MCC App
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders focused on measuring Family Therapy

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FFT with MCC App (FFT-MCC)

FFT with App Assessments only (FFT-Assess)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Average mood symptom scores over 27 weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
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

Mood instability, as rated by parents and children using the Children's Affective Lability Scale (CALS) and the Parent-Rated General Behavior Inventory
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.
Expressed emotion in parents from the Five Minute Speech Sample
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.
Free speech samples coded using the Linguistic Inquiry Word Count system.
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.

Full Information

First Posted
April 9, 2019
Last Updated
October 7, 2022
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03913013
Brief Title
Technology Enhanced Family Treatment
Official Title
Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Bipolar Disorder, Major Depression
Keywords
Family Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The Outcomes assessor will be unaware of whether the patient is in FFT-MCC or FFT-Assess.
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FFT with MCC App (FFT-MCC)
Arm Type
Experimental
Arm Description
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.
Arm Title
FFT with App Assessments only (FFT-Assess)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family-Focused Treatment with MCC App
Intervention Description
12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Primary Outcome Measure Information:
Title
Average mood symptom scores over 27 weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Description
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.
Time Frame
27 weeks, with ratings done by an independent evaluator each week
Secondary Outcome Measure Information:
Title
Mood instability, as rated by parents and children using the Children's Affective Lability Scale (CALS) and the Parent-Rated General Behavior Inventory
Description
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.
Time Frame
Mean Children's Affective Lability scores computed at baseline and every 9 weeks for 27 weeks
Title
Expressed emotion in parents from the Five Minute Speech Sample
Description
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.
Time Frame
Ratings of high vs. low expressed emotion in each parent obtained at baseline and every 9 weeks for 27 weeks.
Title
Free speech samples coded using the Linguistic Inquiry Word Count system.
Description
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.
Time Frame
weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armen Arevian, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David J Miklowitz, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-1759
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
27471058
Citation
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.
Results Reference
background
PubMed Identifier
33360365
Citation
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.
Results Reference
derived
Links:
URL
https://www.semel.ucla.edu/champ
Description
UCLA Child and Adolescent Mood Disorders program

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