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

Not Applicable

Completed

• Conditions: Parent-Child Relations; Preterm Infants; Early Interventions
• Interventions: Behavioral: BS; Behavioral: BS+PITP; Behavioral: PITP; Behavioral: Routine care

• Registration Number: NCT03013023
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2017-03
• Study Completion: 2017-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-31
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Gestational age (GA) > 28 weeks and < 37 weeks
2. Postbirth age >2 days
3. Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity).
4. Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
5. Parents are fluent in Chinese
6. Parents do not use drugs
7. Parents agree to participate in this study

Exclusion Criteria

1. Congenital anomalies
2. Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
3. Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
4. Surgery
5. Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral-support interventions (BS)	BS	NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures
BS+PITP	BS+PITP	Behavioral-support interventions + Parent-infant transaction program
Parent-infant transaction program (PITP)	PITP	The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge.
Routine care	Routine care	Control group

Primary Outcome Measures

Name	Time	Method
Parent stress	7days to 12 months	Accessed by Parenting Stress Index-Short form (PSI-SF)
Parent depression	7days to 12 months	Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
Parent sleep	7days to 12 months	Accessed by Pittsburgh Sleep Quality Index
Parent social support	7days to 12 months	Accessed by the Social Support Rating Scale (SSRS)

Secondary Outcome Measures

Name	Time	Method
Preterm infant's stress	up to 3 months	Assessed by Salivary cortisol
Parent-infant interaction	1 month to 6 months	Assessed by NCASTfeeding scale
Preterm infant's sleep	up to 3 months	Assessed by Actigraphy