Phase 1: Controlled Trials – Multi-Site Randomized Controlled Trial (RCT) of Daphne's Hometree Recovery Model for Schizophrenia and Cerebral Palsy
Expanded Phase 1 Protocols (2027–2029) | On A Coherence-Based Sanctuary Model for Adults with Schizophrenia and Cerebral Palsy Trial
Expanded Phase 1 Protocols (2027–2029)
Phase 1: Controlled Trials – Multi-Site Randomized Controlled Trial (RCT)
Study Title
“Daphne’s Hometree: A Multi-Site Randomized Controlled Trial of a Coherence-Based Sanctuary Model for Adults with Schizophrenia and Cerebral Palsy”
Study Design
Type: Prospective, multi-center, parallel-group, randomized controlled trial (RCT) with 1:1 allocation.
Sites: 3 specialized Hometree-style residential/day-program sites (one CP-focused, one schizophrenia-focused, one mixed-cohort site) located in geographically diverse regions (e.g., Pacific Northwest, Midwest, and Southeast U.S.).
Duration: 18-month intervention + 6-month follow-up (total 24 months per participant).
Randomization: Stratified block randomization (stratified by primary diagnosis and baseline severity) using computer-generated sequences with allocation concealment.
Blinding: Outcome assessors and data analysts blinded; participants and direct care staff cannot be blinded due to the nature of the intervention.
Objectives
Primary: To determine whether the Hometree coherence-based sanctuary model produces superior functional outcomes compared with standard care in adults with schizophrenia and/or cerebral palsy.
Secondary: To evaluate effects on autonomic regulation (HRV), executive function, symptom burden, quality of life, and mechanistic biomarkers of coherence (inflammation, microtubule-related markers if available).
Exploratory: Cost-effectiveness, caregiver burden, and long-term sustainability of gains.
Study Population
Inclusion Criteria (common to both conditions):
Age 18–65 years.
Confirmed diagnosis of schizophrenia/schizoaffective disorder (DSM-5-TR) or cerebral palsy (GMFCS I–IV).
Stable medical status (no acute hospitalization in past 3 months).
Willing and able to participate in a residential or intensive day-program model for 12–18 months.
Capacity to provide informed consent (or legal guardian assent with participant assent where applicable).
Condition-Specific Criteria:
Schizophrenia arm: Moderate-to-severe symptoms (PANSS total score ≥ 60) and/or executive dysfunction (e.g., BRIEF-A score > 65).
Cerebral palsy arm: Documented motor impairment with secondary complications (spasticity, pain, or executive dysfunction).
Exclusion Criteria:
Acute medical instability, active substance dependence requiring primary treatment, or severe cognitive impairment precluding consent/participation.
Pregnancy or plans for pregnancy during study period.
Inability to tolerate tVNS or participate in group activities.
Target Enrollment: 240 participants total (80 per site), with 120 per arm (Hometree vs. standard care).
Intervention Arms
Hometree Coherence Protocol (Experimental Arm)
Core Components (delivered 6–7 days/week):
Daily 20–30 min non-invasive tVNS (auricular or cervical, titrated to comfort).
Structured co-regulation circles (group and 1:1 peer support emphasizing safety and non-judgment).
Creative expression blocks (writing, art, music, myth-making) as nervous-system reset.
Fibonacci-inspired movement and spiral architecture for subconscious geometric reinforcement.
Peer-led daily routines with emphasis on “refusal to pretend mean” culture.
Individualized executive-function scaffolding and trauma-informed care.
Duration: 12–18 months full residential/intensive day-program, with step-down transition planning.
Staffing: Peer guides with lived experience + licensed clinicians (minimum 1:4 staff-to-resident ratio).
Standard Care (Control Arm)
Continued treatment as usual (TAU) at referring clinic or community program, including medication management, outpatient therapy, and standard rehabilitation services.
No access to Hometree-specific coherence interventions during the trial (cross-over allowed post-study).
Outcome Measures
Primary Outcomes (assessed at baseline, 6, 12, 18, and 24 months):
Cerebral palsy: Gross Motor Function Classification System (GMFCS) change and Gross Motor Function Measure (GMFM-66).
Schizophrenia: Positive and Negative Syndrome Scale (PANSS) total score and Clinical Assessment of Functioning (CAF).
Combined: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) and Quality of Life Scale (QOLS).
Secondary Outcomes:
Autonomic: 24-hour HRV (RMSSD, HF power).
Executive function: Behavior Rating Inventory of Executive Function–Adult (BRIEF-A), Trail Making Test, Stroop.
Biomarkers: hs-CRP, IL-6, optional microtubule-related markers (acetylated tubulin, tau phosphorylation if assay validated).
Patient-reported: Coherence Scale (newly developed, based on relational safety and creative flow).
Safety Monitoring:
Adverse event tracking (falls, psychiatric decompensation, medical events).
Data Safety Monitoring Board (DSMB) with pre-specified stopping rules.
Statistical Analysis:
Intention-to-treat with mixed-effects models for repeated measures.
Sample size powered at 80% to detect moderate effect size (Cohen’s d = 0.5) at α = 0.05, accounting for 20% attrition.
Timeline and Milestones
Q1 2027: IRB approvals, site training, recruitment begins.
Q2 2027 – Q4 2028: Active enrollment and intervention.
Q1–Q2 2029: Follow-up completion and data lock.
Q3 2029: Primary analysis and manuscript preparation.
Q4 2029: Open-access publication + dissemination to advocacy groups.
Ethics and Community Engagement
Full informed consent with capacity assessment.
Community advisory board including people with lived experience of schizophrenia and CP.
Emphasis on dignity, autonomy, and “refusal to pretend mean” as core ethical principle.
This Phase 1 RCT is the critical first step to demonstrate that a coherence-based sanctuary model can produce measurable, clinically meaningful gains beyond standard care. Positive results will provide the evidence base for larger Phase 2 scaling and eventual policy integration.
