An interventional study of Group Therapy and Treatment as Usual (TAU) in Schizophrenia; Psychosis, sponsored by Boston Children's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
While early onset schizophrenia spectrum disorders are among the most debilitating psychiatric illnesses, evidence-based treatment for this population is limited. This study evaluates the feasibility and acceptability of a parent peer co-led group intervention for caregivers of youth with Early Onset Schizophrenia Spectrum Disorder to support further refinement.
Caregivers of youth with Early Onset Schizophrenia Spectrum Disorder will be invited to participate. Participants will be assigned to either the treatment group or the wait-list control group. Those in the treatment group will receive the group intervention immediately at study start and wait-list participants will be invited to participate following completion of the study. The group intervention consists of 10 group therapy intervention sessions covering psychosis psychoeducation (e.g. symptoms monitoring, stress \& stress management, family communication skills, and coping skills).
Feasibility will be assessed through recruitment and retention, acceptability through the Client Satisfaction Questionnaire. Secondary aims include effectiveness using Goal Attainment Scaling (GAS), Perceived Stress Scale (PSS), and qualitative feedback from participants.
Schizophrenia spectrum disorders (SSD) are a group of disorders defined by the presence of delusions, hallucinations, disorganized thinking, grossly disorganized or abnormal motor behavior, and/or negative symptoms, and typically present between late teens and mid-30s. While treatment approaches for adults with SSD are well-established, evidence-based psychosocial interventions for pediatric early-onset SSD (EOSSD; onset \<18 years) remain limited. Current recommendations emphasize psychotropic interventions, with little empirical support for psychosocial treatments, underscoring the urgent need for clinical research in this population.
Although extensive research supports psychosocial interventions for first episode psychosis (FEP), studies specific to pediatric EOSSD are scarce. Existing research has evaluated cognitive remediation, cognitive behavioral therapy (CBT), and family interventions [5] for EOSSD. In one study comparing CBT to treatment-as-usual (TAU), no significant differences emerged on PANSS scores; follow-up completion was low, and only 3 of 11 participants achieved a good response (>50% reduction in PANSS total score) [6]. A recent review by Kelleher et al. [2] concluded that such poor outcomes suggest there is limited effectiveness of CBT for EOSSD in real-world care, highlighting the need for alternative treatment approaches.
In addition to the limited evidence on individual psychosocial approaches, even though including caregivers/families in treatment is an integral component in gold-standard care in FEP treatment, to our knowledge only one other study has explored the effects of a caregiver/family-focused intervention for pediatric EOSSD. In this one study, participants who were in the structured family intervention had significantly fewer visits to the emergency department (13% vs 50%) and saw greater symptom improvement.
The use of parent peers (also termed parent partners or parent-to-parent programs) is an emerging strategy for delivering psychoeducation and support to parents of youth with behavioral health challenges (e.g. autism, inpatient hospitalization) with promising evidence. A review of 25 parent-to-parent interventions for caregivers of youth with autism found that parents were effective in delivering the intervention and reported benefits to include developing a sense of belonging and alleviating social isolation, which are frequently reported as areas of need by our caregivers of youth with EOSSD.
In sum, while psychosocial interventions are well-studied in adult SSDs, pediatric EOSSD remains an under-researched area with poor treatment outcomes. The few existing studies show that caregiver and peer involvement may be particularly impactful. To address these gaps, the current study will evaluate the feasibility and acceptability of a psychoeducation group for caregivers of youth ≤18 years with EOSSD (schizophrenia, schizoaffective disorder), co-led, and co-designed by a licensed psychologist and a caregiver with lived experience.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
Participants in the Treatment Group will attend 10 group therapy sessions.
Behavioral: Group Therapy
Participants in the wait-list control arm will serve as a comparison group for the duration of the primary intervention period. Upon completion of the primary study endpoints and post-tests, the wait-list control group will be offered the opportunity to receive the identical intervention.
Other: Treatment as Usual (TAU)
The intervention consists of 10 sessions. Intervention sessions are held over a secure zoom platform, for 1-1.5 hrs, with up to 10 participants, once/week. The group will be facilitated by licensed psychologist. The group sessions will include, 1) Introductions, Goal Setting, Group Norms, Overview of Group, 2) Psychosis Psychoeducation, 3) Developmental Considerations, 4) Mental Health Systems \& Collaborating with Schools, 5) Role of Stress and Decreasing Stress in the Home, 6) Communication Skills, 7) Health Behaviors, 8) Coping Skills \& The Science of Psychosis, 9) Medications \& Prevention Planning, 10) Goal Setting \& Wrap-Up.
Participants in the Waitlist group will receive treatment as usual (parent support and guidance from child's clinician, individual therapy for child, and psychopharmacological medication management for their child).
Feasibility measured as attendance to the group sessions
The average number of total group sessions attended
Time frame: Immediately following the last intervention session
Acceptability as measured on the Client Satisfaction Questionnaire-Participant Versions (CSQ)
Client Satisfaction Questionnaire-Participant (CSQ) - used to assess acceptability of intervention, as defined by participant ratings on quality of service, fits of the intervention to meet need to support satisfaction, and overall satisfaction.
Time frame: Within two weeks following group intervention completion
Effectiveness of the intervention as measured on progress on the Goal Attainment Scale (GAS)
Effectiveness is defined as progress made towards individualized patient's goals, we will assess the difference in progress made towards goals between those in the wait-list control and treatment group. Progress towards caregiver goals will be measured using Goal Attainment Scale (GAS).
Time frame: Within two weeks following group intervention completion
Social Validity
Social validity as assessed via the Semi-structured Interview for Social Validation
Time frame: Post-Intervention
Plan to share: No
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