Clinical trial NCT03913013: Technology Enhanced Family Treatment
Official title: Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mood Disorders
Bipolar Disorder
Major Depression
Keywords: Family Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-04-12
Enrollment: 65
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
timeFrame: 27 weeks (average rating across this time period)
Secondary outcomes:
measure: Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)
timeFrame: Outcomes scores at 27 weeks
measure: Expressed Emotion in Parents From the Five Minute Speech Sample
timeFrame: Count of participants with primary parent rated high in expressed emotion at 27 weeks.
measure: Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.
timeFrame: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
measure: Children's Global Assessment of Functioning
timeFrame: Means are reported at 27 weeks (study endpoint)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Armen Arevian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: David J Miklowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.