Bipolar Disorder, Major Depression, Mood Disorders
Conditions
Keywords
Family Therapy
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.
Interventions
BEHAVIORALFamily-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.
Sponsors
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The Outcomes assessor will be unaware of whether the patient is in FFT-MCC or FFT-Assess.
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation | 27 weeks (average rating across this time period) | Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of weekly depressive symptom fluctuation based on an interview with the child and parent (or parent unit). The primary outcome variable for this study is the average of the ALIFE weekly consensus ratings. For the ALIFE, an independent evaluator rates the child's level of depression each week for 27 weeks on a Psychiatric Status Rating (PSR) scale ranging from 1 (asymptomatic) to 6 (extremely symptomatic). Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder) and scores of 1-2 are considered remitted. For each of 27 weeks the evaluator provides a separate rating based on the child interview and parent interview and then calculates a weekly consensus rating per ALIFE developer guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS) | Outcomes scores at 27 weeks | Children's Affective Lability Scale (CALS) is a 20-item parent-report survey that measures youth difficulty with affective regulation. Each item corresponds to a particular problem in affective regulation, with responses offered on a five-point scale ranging from 0 = Never or rarely occurs to 4 = 1 or more times a day). The total possible score is a sum of item scores and ranges from 0 to 80. Lower scores indicate less affective lability. In this study, a score of 20 or higher was used to indicate high mood instability. |
| Expressed Emotion in Parents From the Five Minute Speech Sample | Count of participants with primary parent rated high in expressed emotion at 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 over-involvement. One critical comment or a rating of present for hostility or over-involvement means the parent is rated high in expressed emotion, and low expressed emotion otherwise. |
| Free Speech Samples Coded Using the Linguistic Inquiry Word Count System. | 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. |
| Children's Global Assessment of Functioning | Means are reported at 27 weeks (study endpoint) | The Children's Global Assessment of Functioning is a 1-100 rating of level of psychosocial functioning in the past 2 weeks. Higher scores indicate better functioning. |
Countries
United States
Participant flow
Pre-assignment details
The participant enrollment numbers reflect youth participants enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 32 |
| 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.
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. | 33 |
| Total | 65 |
Baseline characteristics
| Characteristic | FFT With App Assessments Only (FFT-Assess) | FFT With MCC App (FFT-MCC) | Total |
|---|---|---|---|
| Age, Continuous Age, Mean yrs (SD) | 15.9 years STANDARD_DEVIATION 1.5 | 15.6 years STANDARD_DEVIATION 1.7 | 15.8 years STANDARD_DEVIATION 1.6 |
| Diagnosis Bipolar spectrum disorder | 6 Participants | 6 Participants | 12 Participants |
| Diagnosis Depressive spectrum disorder | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 6 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 26 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 7 / 32 | 9 / 33 |
| serious Total, serious adverse events | 5 / 32 | 3 / 33 |
Outcome results
Primary
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of weekly depressive symptom fluctuation based on an interview with the child and parent (or parent unit). The primary outcome variable for this study is the average of the ALIFE weekly consensus ratings. For the ALIFE, an independent evaluator rates the child's level of depression each week for 27 weeks on a Psychiatric Status Rating (PSR) scale ranging from 1 (asymptomatic) to 6 (extremely symptomatic). Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder) and scores of 1-2 are considered remitted. For each of 27 weeks the evaluator provides a separate rating based on the child interview and parent interview and then calculates a weekly consensus rating per ALIFE developer guidelines.
Time frame: 27 weeks (average rating across this time period)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FFT With MCC App (FFT-MCC) | Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation | 3.39 score on a scale | Standard Deviation 1.15 |
| FFT With App Assessments Only (FFT-Assess) | Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation | 3.09 score on a scale | Standard Deviation 0.91 |
Secondary
Children's Global Assessment of Functioning
The Children's Global Assessment of Functioning is a 1-100 rating of level of psychosocial functioning in the past 2 weeks. Higher scores indicate better functioning.
Time frame: Means are reported at 27 weeks (study endpoint)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FFT With MCC App (FFT-MCC) | Children's Global Assessment of Functioning | 65.97 score on a scale | Standard Error 2.51 |
| FFT With App Assessments Only (FFT-Assess) | Children's Global Assessment of Functioning | 62.16 score on a scale | Standard Error 2.51 |
Secondary
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 over-involvement. One critical comment or a rating of present for hostility or over-involvement means the parent is rated high in expressed emotion, and low expressed emotion otherwise.
Time frame: Count of participants with primary parent rated high in expressed emotion at 27 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FFT With MCC App (FFT-MCC) | Expressed Emotion in Parents From the Five Minute Speech Sample | 17 Participants |
| FFT With App Assessments Only (FFT-Assess) | Expressed Emotion in Parents From the Five Minute Speech Sample | 16 Participants |
Secondary
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.
Time frame: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
Secondary
Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)
Children's Affective Lability Scale (CALS) is a 20-item parent-report survey that measures youth difficulty with affective regulation. Each item corresponds to a particular problem in affective regulation, with responses offered on a five-point scale ranging from 0 = Never or rarely occurs to 4 = 1 or more times a day). The total possible score is a sum of item scores and ranges from 0 to 80. Lower scores indicate less affective lability. In this study, a score of 20 or higher was used to indicate high mood instability.
Time frame: Outcomes scores at 27 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FFT With MCC App (FFT-MCC) | Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS) | 38.43 score on a scale | Standard Deviation 14.12 |
| FFT With App Assessments Only (FFT-Assess) | Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS) | 33.79 score on a scale | Standard Deviation 11.9 |