Miklowitz, D. J., Axelson, D. A., Birmaher, B., George, E. L., Taylor, D. O., Schneck, C. D., & Brent, D. A. (2008). Family-Focused Treatment for Adolescents with bipolar disorder: Results of a 2-year randomized trial. Archives of General Psychiatry, 65(9), 1053–1061. https://doi.org/10.1001/archpsyc.65.9.1053

Type of Study: Randomized controlled trial
Number of Participants: 58

Population:

• Age — 12–17 years
• Race/Ethnicity — 3 Biracial, 3 Hispanic, 1 African American, 1 Asian/Pacific Islander, 1 Native American, and remainder unspecified
• Gender — 57% Female and 43% Male
• Status — Participants were adolescents with bipolar disorder who were recruited through direct referral by community psychiatrists or the inpatient units of Children's Hospital of Denver.

Location/Institution: University of Colorado & University of Pittsburgh School of Medicine

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to evaluate the efficacy of Family-Focused Treatment for Adolescents (FFT-A) in a sample of adolescents with bipolar disorder. Participants were randomly assigned to a FFT-A treatment group with protocol pharmacotherapy or to a control group of enhanced care (EC) and protocol pharmacotherapy. Measures utilized include the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children – Present and Lifetime Version (K-SADS-PL), K-SADS Depression and Mania Rating Scales (DRS and MRS), and the Child’s Global Assessment Scale (C-GAS). Results indicate that participants in FFT-A recovered from depressive symptoms faster than patients in EC. Also, patients in FFT-A had greater overall reductions in mood severity scores (including mania, hypomania, and depression symptoms) than patients in EC over 2 years. Limitations include the small sample size, variability in treatment length among participants, and lack of ethnic diversity in the sample.

Length of controlled postintervention follow-up: 15 months.

Miklowitz, D. J., Axelson, D. A., George, E. L., Taylor, D. O., Schneck, C. D., Sullivan, A. E., Birmaher, B. (2009). Expressed emotion moderates the effects of Family-Focused Treatment for bipolar adolescents. Journal of the American Academy of Child and Adolescent Psychiatry, 48(6), 643–651. https://doi.org/10.1097/CHI.0b013e3181a0ab9d

Type of Study: Randomized controlled trial
Number of Participants: 52

Population:

• Age — 12–17 years
• Race/Ethnicity — 6% Biracial, 2% Asian/Pacific Islander, 2% Hispanic, 2% Native American, 2% African American, and remainder unspecified
• Gender — 63% Female and 37% Male
• Status — Participants were adolescents with bipolar disorder who were recruited through direct referral by community psychiatrists or the inpatient units of Children's Hospital of Denver.

Location/Institution: University of Colorado and University of Pittsburgh School of Medicine

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the same sample as Miklowitz et al. (2008). The purpose of the study was to evaluate the moderating effects of parental expressed emotion on the 2-year symptomatic outcomes of adolescent bipolar disorder patients assigned to Family-Focused Treatment for Adolescents (FFT-A) or a brief psychoeducational treatment (enhanced care). Participants were randomly assigned to a FFT-A treatment group with protocol pharmacotherapy or to a control group of enhanced care (EC) and protocol pharmacotherapy. Measures utilized include the Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children – Present and Lifetime Version (K-SADS-PL), K-SADS Depression and Mania Rating Scales (DRS and MRS), Child’s Global Assessment Scale (C-GAS), Camberwell Family Interview for EE, and the Family Adaptability and Cohesion Scale-II (FACES-II). Results indicate that parents rated high in parental expressed emotion described their families as lower in cohesion and adaptability than parents rated low in parental expressed emotion. Adolescents in high-parental expressed emotion families showed greater reductions in depressive and manic symptoms in FFT-A than in enhanced care, suggesting that parental expressed emotion moderates the impact of family intervention on the symptomatic trajectory of adolescent bipolar disorder. Limitations include the small sample size, variability in treatment length among participants, and lack of ethnic diversity in the sample.

Length of controlled postintervention follow-up: 15 months.

Miklowitz, D. J., Schneck, C. D., George, E. L., Taylor, D. O., Sugar, C. A., Birmaher, B., Kowatch, R. A., DelBello, M. P., & Axelson, D. A. (2014). A 2-year randomized trial of pharmacotherapy and family-focused treatment for adolescents with bipolar I and II disorders. American Journal of Psychiatry, 171(6), 658–667. https://doi.org/10.1176/appi.ajp.2014.13081130

Type of Study: Randomized controlled trial
Number of Participants: 145

Population:

• Age — Mean=15.6 years
• Race/Ethnicity — 17% Non-White and 9% Hispanic
• Gender — 54% Female
• Status — Participants were children with Bipolar I or II disorders and a DSM-IV-TR manic, hypomanic, depressive, or mixed episode in the previous 3 months.

Location/Institution: University of Colorado, the University of Pittsburgh School of Medicine, and the Cincinnati Children's Hospital Medical Center

Summary: (To include basic study design, measures, results, and notable limitations)
The purpose of the study was to examine whether pharmacotherapy and Family-Focused Treatment for Adolescents (FFT-A) with bipolar disorder was more effective than pharmacotherapy and brief psychoeducation (enhanced care; EC) in decreasing time to recovery from a mood episode, increasing time to recurrence, and reducing symptom severity over 2 years. Participants were randomly assigned either to pharmacotherapy and FFT-A or to pharmacotherapy and three weekly sessions of EC. Measures utilized include the Schedule for Affective Disorders and Schizophrenia for School-Age Children–Present and Lifetime Version (K-SADS-PL), the Therapist Competency and Adherence Scale, and the Adolescent Longitudinal Interval Follow-up Evaluation. Results indicate that the time to recovery or recurrence and proportion of weeks ill did not differ between the two treatment groups. Secondary analyses revealed that participants in FFT-A had less severe manic symptoms during year 2 than did those in enhanced care. Limitations include the high attrition rates at the later follow-up time points.

Length of controlled postintervention follow-up: Varies (3, 6, 9, 12, 18, 24 months).

O'Donnell , L. A., Ellis, A. J., Van de Loo, M. M., Stange, J. P., Axelson, D. A., Kowatch, R. A., Schneck, C. D., & Miklowitz, D. J. (2018). Mood instability as a predictor of clinical and functional outcomes in adolescents with bipolar I and bipolar II disorder. Journal of Affective Disorders, 236, 199–206. https://doi.org/10.1016/j.jad.2018.04.021

Type of Study: Randomized controlled trial
Number of Participants: 145

Population:

• Age — Mean=15.6 years
• Race/Ethnicity — Not specified
• Gender — 79 Female and 66 Male
• Status — Participants were adolescents with bipolar disorder (BD) I or II with a mood episode.

Location/Institution: Three U.S. sites: University of Colorado, Boulder, CO; University of Pittsburgh School of Medicine, Pittsburgh, PA; the University of Cincinnati/Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the same sample as Miklowitz et al. (2014). The purpose of the study was to examine whether mood instability (MI) among adolescents with bipolar disorder (BD) was cross-sectionally related to bipolar subtype (I vs. II) and prognostically associated with symptoms and functioning over 3 months. Participants were randomized to either Family-Focused Treatment for Adolescents (FFT-A) or enhanced care (EC, brief psychoeducation), plus good practice pharmacotherapy. Measures utilized include the Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE) and the Children's Global Assessment Scale (CGAS). Results indicate that greater depression instability was associated with BD II, whereas greater (hypo)mania instability was associated with BD I. Baseline MI, particularly depression, predicted more instability, a higher percentage of weeks in a clinical mood state, and poorer global functioning over 3 months, even when covarying concurrent mood severity scores. Limitations include the clinical measure of symptoms used retrospective reports of clinically significant symptoms only; the sample was primarily Caucasian, from middle to upper class homes; and inability to standardize medication use or adherence.

Length of controlled postintervention follow-up: None.

Weintraub, M. J., Axelson, D. A., Kowatch, R. A., Schneck, C. D., & Miklowitz, D. J. (2019). Comorbid disorders as moderators of response to family interventions among adolescents with bipolar disorder. Journal of Affective Disorders, 246(1), 754–762. https://doi.org/10.1016/j.jad.2018.12.125

Type of Study: Randomized controlled trial
Number of Participants: 145

Population:

• Age — 12–18 years (Mean=15.6 years)
• Race/Ethnicity — Not specified
• Gender — Not specified
• Status — Participants were adolescents with bipolar I or II disorder.

Location/Institution: University of Colorado; the University of Pittsburgh School of Medicine; and the Cincinnati Children's Hospital Medical Center

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the same sample as Miklowitz et al. (2014). The purpose of the study was to examine the effects of comorbid psychiatric conditions on patients’ symptomatic or functional responses to treatment. Participants were randomly assigned to Family-Focused Treatment for Adolescents (FFT-A) or a brief psychoeducational therapy (enhanced care; EC) and followed over 2 years. Measures utilized include the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), the Mania Rating Scale Psychiatric Status Rating Scale (PSR) of the Adolescent Longitudinal Interval Follow-up Evaluation (ALIFE), the ALIFE PSR depression, hypomanic, and manic scales, and the Conflict Behavior Questionnaire (CBQ). Results indicate that comorbid anxiety was associated with a greater proportion of weeks with depressive symptoms, more severe (hypo)manic symptoms during follow-up, and greater family conflict over the 2-year study. Comorbid ADHD was associated with a greater proportion of weeks with (hypo)manic symptoms, more severe (hypo)manic symptoms, and greater family conflict. Additionally, comorbid ADHD moderated the effects of psychosocial treatments on (hypo)manic symptoms and family functioning. Comorbid DBDs were consistently associated with more severe depressive symptoms and greater family conflict throughout the study. Limitations include randomization to treatments was not stratified on comorbid disorders, and the course of anxiety, attentional, and disruptive behavior symptoms were not examined.

Length of controlled postintervention follow-up: 3, 9, and 15 months.

Weintraub, M. J., Schneck, C. D., Axelson, D. A., Birmaher, B., Kowatch, R. A., & Miklowitz, D. J. (2020). Classifying mood symptom trajectories in adolescents with bipolar disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 59(3), 381–390. https://doi.org/10.1016/j.jaac.2019.04.028

Type of Study: Randomized controlled trial
Number of Participants: 144

Population:

• Age — 12–18 years
• Race/Ethnicity — 17% Non-White and 8% Hispanic
• Gender — 55% Female
• Status — Participants included adolescents with a DSM-IV-TR diagnosis of bipolar I or II disorder.

Location/Institution: Three university centers: University of Colorado, Boulder; the University of Pittsburgh School of Medicine; and the Cincinnati Children's Hospital Medical Center

Summary: (To include basic study design, measures, results, and notable limitations)
The study used the same sample as Miklowitz et al. (2014). The purpose of the study was to evaluate whether adolescents with bipolar spectrum disorders followed 1 of 4 distinct mood trajectories. Participants were randomly assigned to one of 2 psychosocial family treatments during the first 9 months of the study, Family-Focused Treatment for Adolescents (FFT-A) or a brief psychoeducational therapy (enhanced care; EC) and pharmacotherapy was provided throughout the 2 years. Measures utilized include the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS), the Adolescent Longitudinal Interval Follow-Up Evaluation (ALIFE), the Hollingshead Scale, the Family History Screen, the Five-Minute Speech Sample, and the Kiddo-KINDLR Questionnaire (KINDL). Results indicate that there were four distinct mood trajectories: predominantly euthymic, ill with significantly improving course, moderately euthymic, and ill with moderately improving course. Adolescents in these classes were euthymic. Psychosocial treatment condition and baseline medication exposure were not associated with trajectories. However, youth with more severe baseline depressive symptoms, suicidality, lower quality of life scores, and minority race/ ethnicity had more symptomatic courses of illness over time. Limitations include the sample size, especially for small subgroup comparisons limited the ability to detect differences; the generalizability of the findings pertain mostly to older adolescents with bipolar disorder; and recall and hindsight bias.

Length of controlled postintervention follow-up: 9 and 15 months.

The following studies were not included in rating FFT-A on the Scientific Rating Scale...

Miklowitz, D. J., Weintraub, M. J., Ichinose, M. C., Denenny, D. M., Walshaw, P. D., Wilkerson, C. A., Frey, S.J., Morgan-Fleming, G. M., Brown, R. D., Merranko, J. A., & Arevian, A. C. (2023). A randomized clinical trial of Technology-Enhanced Family-Focused Therapy for youth in the early stages of mood disorders. JAACAP Open, In Press. https://doi.org/10.1016/j.jaacop.2023.04.002

The purpose of the study was to examine whether the effects of telehealth-based Family-focused therapy (FFT) [now called Family-Focused Treatment for Adolescents (FFT-A)] were augmented by mobile health apps that emphasized mood tracking and family coping skills in symptomatic adolescents whose parents had histories of mood disorders. Participants received 12 sessions in 18 weeks of telehealth FFT, with random assignment to (1) a mobile app (MyCoachConnect, MCC) that enabled mood tracking, reviews of session content, and text reminders to practice mood management and family communication skills (FFT-MCC); or (2) a mobile app that enabled mood tracking only (FFT-Track). Measures utilized include the Children’s Global Assessment Scale (CGAS), the Longitudinal Interval Follow-up Evaluation, the Child Anxiety and Related Emotional Disorders (SCARED), the Children’s Depression Rating Scale, Revised, the MINI International Neuropsychiatric Interview, the Child and Adolescent Version for DSM-5 (MINI-KID), the Parent General Behavior Inventory for Mania, the Children’s Affective Lability Scale (CALS), the MINI International Neuropsychiatric Interview for Adults, and the Perceived Criticism Scale. Results indicate that participants significantly improved in depressive symptoms over 6 months, but there were no effects of treatment condition or treatment by time interactions on depression scores. When secondary outcome measures were considered, the subgroup of youth with bipolar spectrum disorders showed greater improvements in anxiety and global functioning in FFT-MCC compared with FFT-Track. Limitations include the weekly app check-ins requested of both groups were lower than expected, maintaining users’ interest in apps that seek to improve mental health, and length of follow-up. Note: Since this study is an adaptation of Family-Focused Treatment for Adolescents (FFT-A), it was not used in the rating/review process.