NCT07116148

Hybrid Early Intervention for Infants at Risk of Cerebral Palsy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 4 Months – 10 Months
• Healthy volunteers: Not accepted

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.

Detailed description

This study aimed to evaluate the feasibility, safety, caregiver acceptability, and satisfaction levels of the Homeostasis-Enrichment-Plasticity (HEP®) Approach, a novel early intervention model based on the environmental enrichment (EN) paradigm and widely used in the literature, as a hybrid approach for infants at risk for cerebral palsy (CP). Furthermore, the effects of the intervention on the achievement of individualized functional goals, developmental outcomes, and parental well-being will be examined. Unlike previous studies, the HEP intervention in this study will be implemented as a hybrid model, implemented both in the clinic and at home. The intervention will be delivered in one-hour sessions per week for 12 weeks to 17 infants aged 4-10 months corrected age, identified as at risk for CP through either the Prechtl Assessment of General Movements or abnormal brain imaging confirmed by a pediatric neurologist. The feasibility, safety, and caregiver acceptance of the intervention will be assessed using a 24-item Likert-type scale developed by the researcher. Developmental outcomes will be measured by the Goal Attainment Scale (GAS), Bayley Developmental Scales for Infants and Toddlers-III (Bayley-III), Infant Sensory Function Test (ISFT), and Depression Anxiety Stress Scale-21 (DASS-21).

Conditions

• Cerebral Palsy (CP)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-05
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-08-11
• Last updated: 2025-11-14

Locations

2 sites across 1 country: Turkey (Türkiye)