TY - JOUR
T1 - Early intervention versus treatment as usual for adolescents with first-episode psychosis
T2 - Protocol for the randomized OPUS YOUNG trial
AU - Madsen, Mathilde S.
AU - Melau, Marianne
AU - Andersen, Naja K.
AU - Nielsen, Caroline Friis
AU - Larsen, Natascha
AU - Andersen, Thomas Lind
AU - Nordentoft, Merete
AU - Jepsen, Jens Richardt M.
AU - Thorup, Anne A.E.
AU - Jeppesen, Pia
AU - Fagerlund, Birgitte
AU - Rimvall, Martin Køster
AU - McGorry, Patrick
AU - Singh, Swaran
AU - Vernal, Ditte Lammers
AU - Hastrup, Lene Halling
AU - Olsen, Lis Raabæk
AU - Rydkjær, Jacob
AU - Correll, Christoph U.
AU - Christensen, Robin
AU - Pagsberg, Anne Katrine
N1 - Publisher Copyright:
© 2026 The Authors
PY - 2026/3
Y1 - 2026/3
N2 - Background: The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials have investigated EIS in samples of patients aged <18 years. We will examine benefits and harms of a new integrated intervention OPUS YOUNG for EOP. The primary objective is to compare the effect of the OPUS YOUNG intervention versus treatment as usual (TAU) on change in social functioning at end-of-treatment after two years. Methods: This investigator-initiated, single-center, pragmatic randomized clinical trial with blinded outcome assessment takes place in child- and adolescent mental health services in Copenhagen, Denmark. We randomize 290 participants aged 12 to 17 years with first-onset psychosis in a 1:1 ratio to a two-year intervention with OPUS YOUNG versus TAU. The OPUS YOUNG manual builds on the Danish evidence-based intervention for young adults (OPUS) adjusted to meet the specific needs of youths. The primary outcome is social functioning (Personal and Social Performance Scale [PSP] total score). Key secondary outcomes include measures of psychotic, negative, and disorganized symptom dimensions, client satisfaction, and health-related quality of life. Analyses will follow the intention-to-treat principle and use mixed-effects repeated measures models. Discussion: In a rigorous research design, we address the urgent need for evidence-based interventions integrating psychosocial and pharmacological treatments in an age-appropriate manualized program for EOP. The primary trial limitations are the risk of attrition during follow-up, and the inherent inability to mask for allocation in trials with psychosocial interventions. Trial registration: ClinicalTrials.gov: NCT04916626, registered June 2021. Protocol and modifications is presented here: https://classic.clinicaltrials.gov/ct2/show/NCT04916626
AB - Background: The prognosis for early onset psychosis (EOP) is poor for a broad range of outcomes. Early intervention services (EIS) have proven beneficial for adult-onset first-episode psychosis, but no randomized trials have investigated EIS in samples of patients aged <18 years. We will examine benefits and harms of a new integrated intervention OPUS YOUNG for EOP. The primary objective is to compare the effect of the OPUS YOUNG intervention versus treatment as usual (TAU) on change in social functioning at end-of-treatment after two years. Methods: This investigator-initiated, single-center, pragmatic randomized clinical trial with blinded outcome assessment takes place in child- and adolescent mental health services in Copenhagen, Denmark. We randomize 290 participants aged 12 to 17 years with first-onset psychosis in a 1:1 ratio to a two-year intervention with OPUS YOUNG versus TAU. The OPUS YOUNG manual builds on the Danish evidence-based intervention for young adults (OPUS) adjusted to meet the specific needs of youths. The primary outcome is social functioning (Personal and Social Performance Scale [PSP] total score). Key secondary outcomes include measures of psychotic, negative, and disorganized symptom dimensions, client satisfaction, and health-related quality of life. Analyses will follow the intention-to-treat principle and use mixed-effects repeated measures models. Discussion: In a rigorous research design, we address the urgent need for evidence-based interventions integrating psychosocial and pharmacological treatments in an age-appropriate manualized program for EOP. The primary trial limitations are the risk of attrition during follow-up, and the inherent inability to mask for allocation in trials with psychosocial interventions. Trial registration: ClinicalTrials.gov: NCT04916626, registered June 2021. Protocol and modifications is presented here: https://classic.clinicaltrials.gov/ct2/show/NCT04916626
KW - Adolescents
KW - Children
KW - Early intervention services
KW - Early onset
KW - Psychosis
KW - Randomized clinical trial
KW - Schizophrenia
UR - https://www.scopus.com/pages/publications/105029509304
U2 - 10.1016/j.cct.2026.108253
DO - 10.1016/j.cct.2026.108253
M3 - Journal article
C2 - 41654084
AN - SCOPUS:105029509304
SN - 1551-7144
VL - 162
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 108253
ER -