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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Parent-Child Relations; Early Interventions
• Intervention / Treatment: Behavioral: Routine care; Behavioral: BS; Behavioral: PITP; Behavioral: BS+PITP

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Routine care; Control group	Behavioral: Routine care; Routine NICU care
ACTIVE_COMPARATOR: Behavioral-support interventions (BS); NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures	Behavioral: BS; NNS, FT, positional support, and oral sucrose feeding
ACTIVE_COMPARATOR: Parent-infant transaction program (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.	Behavioral: PITP; Parents will learn to regulate infant responses while implementing caregiving activities.
ACTIVE_COMPARATOR: BS+PITP; Behavioral-support interventions + Parent-infant transaction program	Behavioral: BS+PITP; Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Defense Medical Center, Taiwan
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Study Chair: Jen-Jiuan Liaw, Professor, Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ACTUAL): March 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Sleep; Salivary cortisol; Preterm Infants; Behavioral and Transaction Interventions; Parents' Biopsychosocial Well-being
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 1-103-05-165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO