Dataset Information

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

ABSTRACT:

Importance

Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths.

Objective

To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood symptoms.

Design, settings, and participants

This multisite randomized clinical trial included referred youths (aged 9-17 years) with major depressive disorder or unspecified (subthreshold) bipolar disorder, active mood symptoms, and at least 1 first- or second-degree relative with bipolar disorder I or II. Recruitment started from October 6, 2011, and ended on September 15, 2016. Independent evaluators interviewed participants every 4 to 6 months to measure symptoms for up to 4 years. Data analysis was performed from March 13 to November 3, 2019.

Interventions

High-risk youths and parents were randomly allocated to FFT (12 sessions in 4 months of psychoeducation, communication training, and problem-solving skills training; n?=?61) or enhanced care (6 sessions in 4 months of family and individual psychoeducation; n?=?66). Youths could receive medication management in either condition.

Main outcomes and measures

The coprimary outcomes, derived using weekly psychiatric status ratings, were time to recovery from prerandomization symptoms and time to a prospectively observed mood (depressive, manic, or hypomanic) episode after recovery. Secondary outcomes were time to conversion to bipolar disorder I or II and longitudinal symptom trajectories.

Results

All 127 participants (82 [64.6%] female; mean [SD] age, 13.2 [2.6] years) were followed up for a median of 98 weeks (range, 0-255 weeks). No differences were detected between treatments in time to recovery from pretreatment symptoms. High-risk youths in the FFT group had longer intervals from recovery to the emergence of the next mood episode (?2?=?5.44; P?=?.02; hazard ratio, 0.55; 95% CI, 0.48-0.92;), and from randomization to the next mood episode (?2?=?4.44; P?=?.03; hazard ratio, 0.59; 95% CI, 0.35-0.97) than youths in enhanced care. Specifically, FFT was associated with longer intervals to depressive episodes (log-rank ?2?=?6.24; P?=?.01; hazard ratio, 0.53; 95% CI, 0.31-0.88) but did not differ from enhanced care in time to manic or hypomanic episodes, conversions to bipolar disorder, or symptom trajectories.

Conclusions and relevance

Family skills-training for youths at high risk for bipolar disorder is associated with longer times between mood episodes. Clarifying the relationship between changes in family functioning and changes in the course of high-risk syndromes merits future investigation.

Trial registration

ClinicalTrials.gov identifier: NCT01483391.

SUBMITTER: Miklowitz DJ

PROVIDER: S-EPMC6990706 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

Miklowitz David J DJ Schneck Christopher D CD Walshaw Patricia D PD Singh Manpreet K MK Sullivan Aimee E AE Suddath Robert L RL Forgey Borlik Marcy M Sugar Catherine A CA Chang Kiki D KD

JAMA psychiatry 20200501 5

<h4>Importance</h4>Behavioral high-risk phenotypes predict the onset of bipolar disorder among youths who have parents with bipolar disorder. Few studies have examined whether early intervention delays new mood episodes in high-risk youths.<h4>Objective</h4>To determine whether family-focused therapy (FFT) for high-risk youths is more effective than standard psychoeducation in hastening recovery and delaying emergence of mood episodes during the 1 to 4 years after an active period of mood sympto ...[more]

PMID: 31940011

Similar Datasets

Project description:ObjectiveWe compared intrinsic network connectivity in symptomatic youths at high risk (HR) for bipolar disorder (BD) and healthy comparison (HC) youths. In HR youths, we also investigated treatment-related changes in intrinsic connectivity after family-focused therapy for high-risk youths (FFT-HR) vs standardized family psychoeducation.MethodHR youths (N = 34; age 9-17 years; mean 14 years, 56% girls and 44% boys) with depressive and/or hypomanic symptoms and at least 1 first- or second-degree relative with BD I or II were randomly assigned to 4 months of FFT-HR (12 sessions of psychoeducation, communication, and problem-solving skills training) or enhanced care (EC; 3 family and 3 individual psychoeducation sessions). Before and after 4 months of treatment, participants underwent resting state functional magnetic resonance imaging (rs-fMRI). A whole-brain independent component analysis compared rs-fMRI networks in HR youths and 30 age-matched HC youths at a pretreatment baseline. Then we identified pretreatment to posttreatment (4-month) changes in network connectivity in HR youths receiving FFT-HR (n = 16) or EC (n = 18) and correlated these changes with depression improvement.ResultsAt baseline, HR youths had greater connectivity between the ventrolateral prefrontal cortex (VLPFC) and the anterior default mode network (aDMN) than did HCs (p = .004). Over 4 months of treatment, FFT-HR-assigned HR youths had increased VLPFC-aDMN connectivity from pre- to posttreatment (p = .003), whereas HR youths in EC showed no significant change over time (p = .11) (treatment by time interaction, t31 = 3.33, 95% CI = 0.27-1.14, p = .002]. Reduction in depression severity over 4 months inversely correlated with enhanced anterior DMN (r = -0.71) connectivity in the FFT-HR but not in the EC (r = -0.07) group (z = -2.17, p = .015).ConclusionCompared to standard psychoeducation, FFT-HR is associated with stronger connectivity between the VLPFC and aDMN, suggesting possible enhancements of self-awareness, illness awareness, and emotion regulation.Clinical trial registration informationEarly Intervention for Youth at Risk for Bipolar Disorder; https://clinicaltrials.gov/; NCT01483391.

Project description:ImportanceAnnual preventive health visits provide an opportunity to screen youths for unhealthy substance use and intervene before serious harm results.ObjectivesTo assess the feasibility and acceptability and estimate the efficacy of a primary care computer-facilitated screening and practitioner-delivered brief intervention (CSBI) system compared with usual care (UC) for youth substance use and associated risk of riding with an impaired driver.Design, setting, and participantsAn intent-to-treat pilot randomized clinical trial compared CSBI with UC among 965 youths aged 12 to 18 years at 5 pediatric primary care offices and 54 practitioners. Patients were randomized to CSBI (n = 628) or usual care (n = 243) groups within practitioner with 12 months of follow-up. Data were collected from February 1, 2015, to December 31, 2017. Data analysis was performed January 1, 2018, to March 30, 2019.InterventionsPatients self-administered a computer-facilitated substance use screening questionnaire before their annual preventive health visits. Immediately after completing the screening, they received their score and level of risk and viewed 10 pages of scientific information and true-life vignettes illustrating health risks associated with substance use. Trained practitioners received the screening results, patients' risk levels, talking points designed to prompt brief counseling, and recommended follow-up plans.Main outcomes and measuresFeasibility and acceptability were assessed using adolescents' postvisit ratings. Days of alcohol use, cannabis use, and heavy episodic drinking were assessed at baseline and 3-, 6-, 9-, and 12-month follow-ups using Timeline Followback, and riding in the past 3 months with a driver who was impaired by use of alcohol or other drugs was assessed using 2 self-report items. The primary outcome was the intervention effect among at-risk youths who reported using alcohol or other drugs in the past 12 months or riding with an impaired driver in the past 3 months at baseline. The secondary outcome was the prevention effect among those with no prior use or risk.ResultsAmong 871 youths screened, 869 completed the baseline assessment; 211 of the 869 reported alcohol or cannabis use in the past 12 months at baseline (mean [SD] age, 16.4 [1.3] years; 114 [54.1%] female; 105 [49.8%] non-Hispanic white). Of the 211 youths, 148 (70.1%) were assigned to the CSBI group and 63 (29.9%) were assigned to the UC group. Among youths in the CSBI group, 105 (70.9%) reported receiving counseling about alcohol, 122 (82.4%) reported receiving counseling about cannabis, and 129 (87.2%) reported receiving counseling about not riding with an impaired driver. Adjusted hazard ratios for time to first postvisit use of alcohol or other drugs for CSBI vs UC were as follows: alcohol use, 0.69 (95% CI, 0.47-1.02); heavy episodic drinking, 0.66 (95% CI, 0.40-1.10); and cannabis use, 0.62 (95% CI, 0.41-0.94). At 12-month follow-ups among 99 youths who reported having ridden in the past 3 months at baseline with an impaired driver (64 in the CSBI group; 35 in the UC group), adjusted relative risk ratio of riding in the past 3 months with an impaired driver for CSBI vs UC groups was 0.58 (95% CI, 0.37-0.91). No intervention effect was observed among youths who reported no prior use of alcohol or other drugs (n = 658) or not having ridden with an impaired driver (n = 769) at baseline.Conclusions and relevanceThe CSBI system is a feasible and acceptable option for screening youths in primary care practice for use of alcohol and other drugs and for risk of riding with an impaired driver, and the estimated efficacy in this sample warrants further testing in larger samples.Trial registrationClinicalTrials.gov identifier: NCT00227877.

Dataset Information

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

Importance

Objective

Design, settings, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effects of Family-Focused Therapy vs Enhanced Usual Care for Symptomatic Youths at High Risk for Bipolar Disorder: A Randomized Clinical Trial.

Similar Datasets

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