Schizophrenia; PsychosisNCT07867964
Feasibility Trial of a Parent Peer-Co-Led Caregiver Group for Pediatric Early Onset Schizophrenia Spectrum Disorders
A study testing Group Therapy and Treatment as Usual (TAU) in people with Schizophrenia; Psychosis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia; Psychosis
- What is being tested?
- Group Therapy and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are 18 years old or older.
- Individuals who are primary caregivers
- Individuals are caregivers of a young person who meets criteria for EOSSD per clinician report.
- Individuals who are fluent in English.
Who cannot join
- Non-fluency in English.
- Impaired decision making capacity per PI review.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Boston Children's Hospital
Brookline, Massachusetts, 02445
Research Coordinator, 617-251-3052, benjamin.mills@childrens.harvard.edu
Bernalyn Ruiz-Yu, PhD
About this study
Official title: Wait-List Controlled Feasibility Trial of a Parent Peer-Co-Led Caregiver Group for Pediatric Early Onset Schizophrenia Spectrum Disorders
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.
Read the detailed description
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.
- Conditions
- Schizophrenia; Psychosis
- Being tested
- Group Therapy, Treatment as Usual (TAU)
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TherapyBehavioural
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.
Treatment as Usual (TAU)Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in the Treatment Group will attend 10 group therapy sessions. Receives: Behavioral: Group Therapy |
| Wait List Control Group | Active comparator | 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. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measured as attendance to the group sessions
The average number of total group sessions attended
Measured: 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.
Measured: Within two weeks following group intervention completion
Secondary outcomes (2)
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).
Measured: Within two weeks following group intervention completion
Social Validity
Social validity as assessed via the Semi-structured Interview for Social Validation
Measured: Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startMay 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernalyn Ruiz-Yu, Boston Children's Hospital
- Investigators
- Bernalyn Ruiz-Yu, PhD, Principal investigator, Boston Children's Hospital, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867964
- Sponsor's protocol ID
- P00054720
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee JD, Terol AK, Yoon CD, Meadan H. Parent-to-parent support among parents of children with autism: A review of the literature. Autism. 2024 Feb;28(2):263-275. doi: 10.1177/13623613221146444. Epub 2023 Jan 1.
PubMed 36588317Lammers EJ, Zickafoose JS, Peterson GG, Blue L, Stewart KA, Kranker K. Parent Partners: Evaluation of a Novel Peer-Support Intervention for the Caregivers of Children Hospitalized for Behavioral Health Conditions. Acad Pediatr. 2019 Nov-Dec;19(8):908-916. doi: 10.1016/j.acap.2019.06.001. Epub 2019 Jun 6.
PubMed 31176786Day C, Michelson D, Thomson S, Penney C, Draper L. Evaluation of a peer led parenting intervention for disruptive behaviour problems in children: community based randomised controlled trial. BMJ. 2012 Mar 13;344:e1107. doi: 10.1136/bmj.e1107.
PubMed 22416059Chien WT, Ho LK, Gray R, Bressington D. A randomized controlled trial of a peer-facilitated self-management program for people with recent-onset psychosis. Schizophr Res. 2022 Dec;250:22-30. doi: 10.1016/j.schres.2022.09.028. Epub 2022 Oct 13.
PubMed 36242787Castelein S, Bruggeman R, van Busschbach JT, van der Gaag M, Stant AD, Knegtering H, Wiersma D. The effectiveness of peer support groups in psychosis: a randomized controlled trial. Acta Psychiatr Scand. 2008 Jul;118(1):64-72. doi: 10.1111/j.1600-0447.2008.01216.x.
PubMed 18595176Rodolico A, Bighelli I, Avanzato C, Concerto C, Cutrufelli P, Mineo L, Schneider-Thoma J, Siafis S, Signorelli MS, Wu H, Wang D, Furukawa TA, Pitschel-Walz G, Aguglia E, Leucht S. Family interventions for relapse prevention in schizophrenia: a systematic review and network meta-analysis. Lancet Psychiatry. 2022 Mar;9(3):211-221. doi: 10.1016/S2215-0366(21)00437-5. Epub 2022 Jan 31.
PubMed 35093198Camacho-Gomez M, Castellvi P. Effectiveness of Family Intervention for Preventing Relapse in First-Episode Psychosis Until 24 Months of Follow-up: A Systematic Review With Meta-analysis of Randomized Controlled Trials. Schizophr Bull. 2020 Jan 4;46(1):98-109. doi: 10.1093/schbul/sbz038.
PubMed 31050757Calvo A, Moreno M, Ruiz-Sancho A, Rapado-Castro M, Moreno C, Sanchez-Gutierrez T, Arango C, Mayoral M. Psychoeducational Group Intervention for Adolescents With Psychosis and Their Families: A Two-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):984-90. doi: 10.1016/j.jaac.2015.09.018. Epub 2015 Oct 13.
PubMed 26598473Fusar-Poli P, McGorry PD, Kane JM. Improving outcomes of first-episode psychosis: an overview. World Psychiatry. 2017 Oct;16(3):251-265. doi: 10.1002/wps.20446.
PubMed 28941089Morrison AP, Pyle M, Maughan D, Johns L, Freeman D, Broome MR, Husain N, Fowler D, Hudson J, MacLennan G, Norrie J, Shiers D, Hollis C, James A; MAPS group. Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study. Lancet Psychiatry. 2020 Sep;7(9):788-800. doi: 10.1016/S2215-0366(20)30248-0. Epub 2020 Jul 7.
PubMed 32649925Anagnostopoulou N, Kyriakopoulos M, Alba A. Psychological interventions in psychosis in children and adolescents: a systematic review. Eur Child Adolesc Psychiatry. 2019 Jun;28(6):735-746. doi: 10.1007/s00787-018-1159-3. Epub 2018 May 4.
PubMed 29728871McDonagh MS, Dana T, Selph S, Devine EB, Cantor A, Bougatsos C, Blazina I, Grusing S, Fu R, Kopelovich SL, Monroe-DeVita M, Haupt DW. Treatments for Schizophrenia in Adults: A Systematic Review [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Oct. Report No.: 17(18)-EHC031-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK487628/
PubMed 29537779Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.
PubMed 29800949Kelleher I. Annual Research Review: Psychosis in children and adolescents: key updates from the past 2 decades on psychotic disorders, psychotic experiences, and psychosis risk. J Child Psychol Psychiatry. 2025 Apr;66(4):460-476. doi: 10.1111/jcpp.14088. Epub 2025 Jan 3.
PubMed 39754377