Clinical Trials Logo

Clinical Trial Summary

Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6-weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, a mixed methods analyses is used to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04555590
Study type Interventional
Source Medical College of Wisconsin
Contact Rosemary White-Traut, PhD,RN,FAAN
Phone 414-337-0261
Email RWhite-Traut@chw.org
Status Recruiting
Phase N/A
Start date November 16, 2020
Completion date April 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT03905278 - Parental Support Intervention in the Oncological Context N/A
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04101799 - Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden N/A
Completed NCT01955551 - Motivational Interviewing to Increase Parent Engagement in Preventive Parenting Programming Phase 2
Completed NCT01432756 - A South African Pilot Worksite Parenting Program to Prevent HIV Among Adolescents N/A
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Completed NCT05930535 - Family-Focused Adolescent & Lifelong Health Promotion N/A
Completed NCT03658122 - Integrating Behavioral Treatment in Primary Care N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT04853888 - ATTACHâ„¢ Program: Promoting Vulnerable Children's Health at Scale N/A
Completed NCT04633434 - Evaluation Study of Talk Parenting Skills N/A
Recruiting NCT04627415 - Project PEAK: Early Intervention for ADHD N/A
Completed NCT04257331 - Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China N/A
Completed NCT03853564 - Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities N/A
Withdrawn NCT05135507 - The Effective Parenting Program (EPP) N/A
Active, not recruiting NCT05264415 - Intergenerational Transmission of Traumatic Stress N/A
Completed NCT04342871 - An Evaluation of the Fathers and Mothers With Cancer Communication Tool N/A
Recruiting NCT04107506 - The Supporting Early Learning Study N/A