Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03913013
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2019-04-09
Brief Title:
Technology Enhanced Family Treatment
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 familys 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 coachinginformational 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 ie 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 n25 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 onlinespeech 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH117200 | NIH | None | httpsreporternihgovquickSearchR34MH117200 |