Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants

Not Applicable

Completed

• Conditions: Feeding Behavior; Preterm Infant; Stress; Mother-Infant Interaction
• Interventions: Behavioral: Stress and Feeding (SAFE)

• Registration Number: NCT03664154
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

A majority of mothers experience high stress levels and associated symptoms of anxiety, depressive symptoms, and sleep disruption during the NICU hospitalization and continuing after hospital discharge. Given preterm infant feeding is one of the most stressful things the new mother will face and given the harmful nature of stress on maternal and infant health, it is important an intervention focuses on both of these concerns: infant feeding and maternal stress. Therefore, the purpose of this research study is two-fold. First, the investigators will examine how practical and acceptable it is for mothers of preterm infants to participate in Stress And FEeding (SAFE) intervention and collect biological stress measures from mothers and their preterm infant's saliva (spit). The intervention is designed to reduce stress and improve maternal feeding interaction. The second purpose of this study is to examine changes before and after using the intervention on mother and infant outcomes over 16-weeks.

Detailed Description

Descriptive statistics will be computed for demographic and outcome variables. The number of mother/infant dyads recruited but not enrolled will be tracked. If provided, reasons for non-participation will be noted. Enrolled dyads will be tracked and monitored for the number of times the interventions are used and completeness of study data. Acceptability and burden will be assessed by theme analysis of the responses to the interview by the mPI's using traditional strategies of reading and re-reading the transcripts, coding participant responses using their language, and developing categories and subcategories to create a structure for considering acceptability will be completed.. Finally, perceptions of usefulness and satisfaction of the mothers will be assessed by looking at frequencies of Likert responses.

Means and standard errors of the maternal stress and feeding behavior variables will be estimated and graphed across the data collection time points. Although the sample size is small, it is anticipated the mixed effects linear model will be used to assess and quantify changes across time. This model will include a random effect for participant and a fixed effect for time. The model is flexible enough to model potential cofactors, such as age at birth. The study will track the number of successfully obtained, transported, processed and stored samples and compare those number to the proposed maternal and infant cortisol collections.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-24
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Study Start: 2019-05-15
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• English-speaking and reading
• Given birth to preterm infant < 35-weeks gestation
• Has access to internet
• Lives within 50-mile radius of hospital

Infant Inclusion Criteria:

• Born less than 35 week gestation
• No congenital anomalies that could interfere with feeding (e.g., diaphragmatic hernia, cleft lip/palate tracheoesophageal fistula, and cardiac anomalies

Maternal

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Exclusion Criteria

• Chronic neuroendocrine or immunologic condition
• Currently using guided imagery or other mind-body techniques such as meditation
• Psychiatric disorder involving a history of dissociative disorders, borderline personalities, and psychotic pathology

Infant Exclusion Criteria:

• Grade III or IV intraventricular hemorrhage
• Surgical necrotizing enterocolitis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stress and Feeding (SAFE)	Stress and Feeding (SAFE)	The SAFE intervention is grounded in a general theory of guided participation (GP) that posits learning will be facilitated by an emotionally regulated state of the mother. Efforts to help mothers manage stress will better position them to learn and attend to feeding their infants. GP links the two components: stress management (SM) and guided feeding (GF). SM provides skills to manage perceived stress and regulate emotion. GF provides education with skill building to help mothers become more sensitive and responsive to their infant. SAFE is delivered through a secure, password-protected responsive website with practice opportunities.

Primary Outcome Measures

Name	Time	Method
Appraisal of SAFE's degree of inconvenience	16-weeks after start of intervention	The participants appraisal of inconvenience will be measured through a semi-structured interview and will be described qualitatively
Satisfaction with intervention	16-weeks after start of intervention	The participants satisfaction with the intervention will be measured using a 26-item Likert scale where 1 represents being not at all satisfied to 5 being very much satisfied.
Adherence	16-weeks after start of intervention	Adherence will be assessed by tracking the number of times the interventions are used
Ease of recruitment of participants	12-months after study opens to enrollment	Number of mother-infant dyads recruited, with a goal of 15
Track non-participation	16-weeks after start of intervention	Track reasons for non-participation via self-report
Data collection completeness	16-weeks after start of intervention	Percent of participants with complete data collection at end of study, with a goal of \>75% of patients

Secondary Outcome Measures

Name	Time	Method
Changes in mother biological stress	Baseline to 16-weeks post-baseline	Biological stress will be assessed by changes in salivary cortisol of mother (an indicator of mother and infant stress)
Change in maternal stress	Baseline to 16-weeks post-baseline	Paper and pencil questions asking about degree to which situations in an individual's life are appraised as stressful and asking about common problems mothers with young children face daily, with higher scores indicating more stress
Changes in mother-infant feeding behaviors	Baseline to 16-weeks post-baseline	Mother and infant feeding behaviors will be assessed using the Parent-Child Early Relational Assessment (PCERA). The PCERA is scored on a 5-point Likert scale on quality, intensity, or amount, and duration of behavior where 1 represents negative behavior of clinical concern and 5 represents regulated, adaptive behavior
Changes in infant biological stress	Baseline to 16-weeks post-baseline	Biological stress will be assessed by changes in salivary cortisol of infant (an indicator of mother and infant stress)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States