NCT07163780

The Effect of the HEP Approach in Infants With Down Syndrome

The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Izgi Miray Demirbag · Academic / Other
• Sex: All
• Age: 4 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.

Detailed description

This clinical study will be conducted at a private clinic in Istanbul and will enroll 26 infants with Down syndrome who meet the inclusion criteria. Participants will be recruited through social media and referrals from professionals who follow infants with Down syndrome. Written informed consent will be obtained from parents after explaining the study's purpose, duration, assessments, and interventions. Demographic, perinatal, natal, and postnatal data will be collected via a "Demographic Information Form." Gross and fine motor skills will be evaluated with Peabody Developmental Motor Scales-2 (PDMS-2), sensory functions with the Infant Sensory Function Test (BDFT), and parents will complete the The Ages and Stages Questionnaires (ASQ) to assess multiple developmental domains. Individual goals will be set using the Goal Attainment Scale (GAS), and social validity will be assessed post-intervention via a parent questionnaire. The intervention group will receive 12 sessions (once a week, 45 minutes each) of HEP therapy, delivered by a physiotherapist experienced in the HEP approach. The control group will receive 12 sessions of traditional therapy administered by an experienced pediatric rehabilitation physiotherapist.

Conditions

• Down Syndrome (DS)

Interventions

Type	Name	Description
BEHAVIORAL	HEP Intervention	This intervention is administered to the HEP Intervention arm. The HEP approach, which includes intervention, is a child-centered, family-based early intervention approach based on the principles of enriched environment and plasticity, emphasizing the importance of homeostasis. It is based on theories that argue that development occurs as a result of the dynamic interaction between the environment, time, task, and individual (Ecological Theory, Dynamic Systems Theory, Perception-Action Theory, Neuronal Group Selection Theory, and the Person-Environment-Occupation Model). Hypotheses for intervention are generated based on a comprehensive assessment of these four fundamental factors (environment, time, task, and individual), and 10 core principles derived from environmental enrichment studies are applied with the guidance of ecological models.
BEHAVIORAL	Traditional Therapy	Participants in this arm will receive conventional pediatric therapy, consisting of 12 weekly sessions of 45 minutes each. Sessions will focus on standard motor and sensory development exercises, delivered by a physical therapist experienced in pediatric rehabilitation.

Timeline

• Start date: 2025-09-03
• Primary completion: 2025-12-03
• Completion: 2025-12-03
• First posted: 2025-09-09
• Last updated: 2025-11-14

Locations

1 site across 1 country: Turkey (Türkiye)