Phase 2
N=65
Technology Enhanced Family Treatment
Mood Disorders · Bipolar Disorder · Major Depression
Bottom Line
View on ClinicalTrials.gov: NCT03913013 ↗Enrolled (actual)
65
Serious AEs
12.3%
Results posted
May 2024
Primary outcome: Primary: Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation — 3.39; 3.09 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Family-Focused Treatment with MCC App (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation |
3.39; 3.09 | — |
| SECONDARY Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS) |
38.43; 33.79 | — |
| SECONDARY Expressed Emotion in Parents From the Five Minute Speech Sample |
17; 16 | — |
| SECONDARY Free Speech Samples Coded Using the Linguistic Inquiry Word Count System. |
— | — |
| SECONDARY Children's Global Assessment of Functioning |
65.97; 62.16 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03913013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.