Feasibility Trial of a Parent Peer-Co-Led Caregiver Group for Pediatric Early Onset Schizophrenia Spectrum Disorders
Part of paid clinical trials in Brookline, Massachusetts.
- Sponsor
- Boston Children's Hospital
- Study ID
- NCT07867964
- Status
- Not Yet Recruiting
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Conditions
- Schizophrenia; Psychosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Group Therapy — BEHAVIORALThe 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.
- Treatment as Usual (TAU) — OTHERParticipants 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).
Study Details
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.
Key Dates
- First listed
- Oct 9, 2026
- Start date
- May 31, 2027
- Status verified
- Oct 2026
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment GroupParticipants in the Treatment Group will attend 10 group therapy sessions.
- Active Comparator: Wait List Control GroupParticipants 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.
Primary Outcome Measure
Feasibility measured as attendance to the group sessions [ Time Frame: Immediately following the last intervention session ]
Central Contacts
- Bernalyn Ruiz-Yu, PhD617-919-5287
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Boston Children's Hospital | Brookline | Massachusetts | 02445 | Bernalyn Ruiz-Yu, PhD (PRINCIPAL_INVESTIGATOR) |
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