Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

Parent-Child Relations Clinical Trial

Official title: Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being

Status Completed

Clinical Trial Summary

This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.

Clinical Trial Description

The proposed study has five specific aims:

1. to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU,

2. to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU,

3. to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns,

4. to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and

5. to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes. ;

Related Conditions & MeSH terms

• Early Interventions
• Parent-Child Relations
• Premature Birth
• Preterm Infants

• NCT number: NCT03013023
• Study type: Interventional
• Source: National Defense Medical Center, Taiwan
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Completion date: August 2017