Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial

William R McFarlane, Bruce Levin, Lori Travis, F Lee Lucas, Sarah Lynch, Mary Verdi, Deanna Williams, Steven Adelsheim, Roderick Calkins, Cameron S Carter, Barbara Cornblatt, Stephan F Taylor, Andrea M Auther, Bentson McFarland, Ryan Melton, Margaret Migliorati, Tara Niendam, J Daniel Ragland, Tamara Sale, Melina Salvador, Elizabeth Spring, William R McFarlane, Bruce Levin, Lori Travis, F Lee Lucas, Sarah Lynch, Mary Verdi, Deanna Williams, Steven Adelsheim, Roderick Calkins, Cameron S Carter, Barbara Cornblatt, Stephan F Taylor, Andrea M Auther, Bentson McFarland, Ryan Melton, Margaret Migliorati, Tara Niendam, J Daniel Ragland, Tamara Sale, Melina Salvador, Elizabeth Spring

Abstract

Objective: To test effectiveness of the Early Detection, Intervention, and Prevention of Psychosis Program in preventing the onset of severe psychosis and improving functioning in a national sample of at-risk youth.

Methods: In a risk-based allocation study design, 337 youth (age 12-25) at risk of psychosis were assigned to treatment groups based on severity of positive symptoms. Those at clinically higher risk (CHR) or having an early first episode of psychosis (EFEP) were assigned to receive Family-aided Assertive Community Treatment (FACT); those at clinically lower risk (CLR) were assigned to receive community care. Between-groups differences on outcome variables were adjusted statistically according to regression-discontinuity procedures and evaluated using the Global Test Procedure that combined all symptom and functional measures.

Results: A total of 337 young people (mean age: 16.6) were assigned to the treatment group (CHR + EFEP, n = 250) or comparison group (CLR, n = 87). On the primary variable, positive symptoms, after 2 years FACT, were superior to community care (2 df, p < .0001) for both CHR (p = .0034) and EFEP (p < .0001) subgroups. Rates of conversion (6.3% CHR vs 2.3% CLR) and first negative event (25% CHR vs 22% CLR) were low but did not differ. FACT was superior in the Global Test (p = .0007; p = .024 for CHR and p = .0002 for EFEP, vs CLR) and in improvement in participation in work and school (p = .025).

Conclusion: FACT is effective in improving positive, negative, disorganized and general symptoms, Global Assessment of Functioning, work and school participation and global outcome in youth at risk for, or experiencing very early, psychosis.

Trial registration: ClinicalTrials.gov NCT00531518.

Keywords: assertive community treatment; family psychoeducation; multifamily group; schizophrenia; supported education; supported employment.

© The Author 2014. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.

Figures

Fig. 1.
Fig. 1.
Flow diagram of participant identification, recruitment, and entry into study.
Fig. 2.
Fig. 2.
Regression-discontinuity outcome. CLR vs CHR (small arrow), p = .0034. CLR vs EFEP (large arrow), p < .0001. Dashed line extending from solid line represents expected regression outcome in the range of CHR and EFEP baseline values, based on CLR values. Regression lines are plotted through group averages with parallel slopes estimated from the primary analysis model. Vertical arrow lengths approximate effect sizes. CHR, clinically higher risk; CLR, clinically lower risk; EFEP, early first-episode psychosis.
Fig. 3.
Fig. 3.
Symptom and functional levels across study intervals. CLR, clinically lower risk, baseline n = 87. CHR, clinically higher risk, baseline n = 205. EFEP, early first-episode psychosis, baseline n = 45. Data points represent mean raw (unadjusted) scores for each subgroup at the respective assessment date.
Fig. 3.
Fig. 3.
Symptom and functional levels across study intervals. CLR, clinically lower risk, baseline n = 87. CHR, clinically higher risk, baseline n = 205. EFEP, early first-episode psychosis, baseline n = 45. Data points represent mean raw (unadjusted) scores for each subgroup at the respective assessment date.
Fig. 3.
Fig. 3.
Symptom and functional levels across study intervals. CLR, clinically lower risk, baseline n = 87. CHR, clinically higher risk, baseline n = 205. EFEP, early first-episode psychosis, baseline n = 45. Data points represent mean raw (unadjusted) scores for each subgroup at the respective assessment date.
Fig. 3.
Fig. 3.
Symptom and functional levels across study intervals. CLR, clinically lower risk, baseline n = 87. CHR, clinically higher risk, baseline n = 205. EFEP, early first-episode psychosis, baseline n = 45. Data points represent mean raw (unadjusted) scores for each subgroup at the respective assessment date.
Fig. 3.
Fig. 3.
Symptom and functional levels across study intervals. CLR, clinically lower risk, baseline n = 87. CHR, clinically higher risk, baseline n = 205. EFEP, early first-episode psychosis, baseline n = 45. Data points represent mean raw (unadjusted) scores for each subgroup at the respective assessment date.

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