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

Study Overview
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Brief Summary
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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
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The proposed study has five specific aims: to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU, to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU, to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns, to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and 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.

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

Conditions
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Early Interventions, Preterm Infants, Parent-Child Relations

Intervention / Treatment
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* Behavioral: BS
* Behavioral: Routine care
* Behavioral: PITP
* Behavioral: BS+PITP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Routine care<br>Control group | Behavioral: Routine care<br>* Routine NICU care<br>|
| Active Comparator: Behavioral-support interventions (BS)<br>NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures | Behavioral: BS<br>* NNS, FT, positional support, and oral sucrose feeding<br>|
| Active Comparator: Parent-infant transaction program (PITP)<br>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<br>* Parents will learn to regulate infant responses while implementing caregiving activities.<br>|
| Active Comparator: BS+PITP<br>Behavioral-support interventions + Parent-infant transaction program | Behavioral: BS+PITP<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol