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

NCT03013023 | Completed DMC

• 1 other identifier: 1-103-05-165
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Early Interventions; Preterm Infants; Parent-Child Relations

Keywords

Behavioral and Transaction Interventions; Parents' Biopsychosocial Well-being; Preterm Infants; Sleep; Salivary cortisol

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Parent-infant interaction

  1 month to 6 months

• Preterm infant's sleep

  up to 3 months

• Preterm infant's stress

  up to 3 months

Study Arms (4)

Routine care

PLACEBO COMPARATOR

Control group

Behavioral: Routine care

Behavioral-support interventions (BS)

ACTIVE COMPARATOR

NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures

Behavioral: BS

Parent-infant transaction program (PITP)

ACTIVE COMPARATOR

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

BS+PITP

ACTIVE COMPARATOR

Behavioral-support interventions + Parent-infant transaction program

Behavioral: BS+PITP

Interventions

BS BEHAVIORAL

NNS, FT, positional support, and oral sucrose feeding

Behavioral-support interventions (BS)

Routine care BEHAVIORAL

Routine NICU care

Routine care

PITP BEHAVIORAL

Parents will learn to regulate infant responses while implementing caregiving activities.

Parent-infant transaction program (PITP)

BS+PITP BEHAVIORAL

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.

BS+PITP

Eligibility Criteria

• Age: 28 Weeks - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead
• Ministry of Science and Technology, Taiwan: collaborator

MeSH Terms

Conditions

Behavior

Study Officials

• Jen-Jiuan Liaw, Professor

  Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator, National Defense Medical Center, Taiwan

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 6, 2017
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share