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RECRUITING
NCT07116148
NA

Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

Sponsor: Medipol University

View on ClinicalTrials.gov

Summary

This study aimed to evaluate the feasibility, safety, and caregiver acceptance of the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention based on the environmental enrichment paradigm, applied as a hybrid model for infants at risk for cerebral palsy (CP). The effects on functional goals, development, and parental well-being will be examined. The intervention consists of weekly one-hour sessions for 12 weeks with 17 infants aged 4-10 months at risk for CP, identified via the Prechtl Assessment or brain imaging. Feasibility and acceptance will be assessed by a 24-item Likert scale. Developmental outcomes will be measured with GAS, Bayley-III, ISFT, and DASS-21.

Official title: Investigation of a Hybrid Environmental Enrichment-Based Early Intervention Approach for Infants at Risk of Cerebral Palsy

Key Details

Gender

All

Age Range

4 Months - 10 Months

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-09-05

Completion Date

2025-11

Last Updated

2025-11-14

Healthy Volunteers

No

Interventions

OTHER

The Homeostasis-Enrichment-Plasticity (HEP®) Approach

The HEPApproach intervention and clinical reasoning process follow a systematic order based on the data-driven decision-making model. There are 11 phases to the HEP Approach process. Phase 1 involves referral to the program. Phase 2 includes a meeting with the family to introduce them to the HEP Approach. Phase 3 is a comprehensive assessment of the child and family systems. Phase 4 is the identification of family and child strengths and challenges based on the assessment. Phase 5 involves formulating hypotheses about how underlying factors or systems impact the child's challenge areas. Phases 6 and 7 include collaborative goal setting and outcome measure identification with the family. Phase 8 is intervention planning. Phase 9 implements the intervention through an individualized process that generally involves four steps that prioritize different areas of need (e.g., self-regulation and homeostasis of the child, adaptation of the physical and social home environment to support succes

Locations (2)

Sense On, Ltd.

Istanbul, Beykoz, Turkey (Türkiye)

Sense On

Istanbul, Beykoz, Turkey (Türkiye)