Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
Condition: Feeding Behavior; Preterm Infant; Stress; Mother-Infant Interaction
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): Stress and Feeding (SAFE)
Intervention type(s): Behavioral
Intervention description(s): The Stress Management component of the intervention acknowledges the mind-body connection between stress and adverse outcomes and consists of four web-based modules based on Lazarus and Folkman's Transactional Model of Stress and Coping designed to improve health outcomes.
The Guided Feeding component of the intervention is based on the synactive theory of development. The synactive theory of development provides insight in to reading the physiological and behavioral cues of infants born preterm and involves weekly viewing of video clips of adaptive and maladaptive feeding behaviors of mothers and infants, practice opportunities, and follow-up phone calls.
Intervention model: Single Group Assignment
Intervention model description: A one-group longitudinal repeated measures design. Data will be collected at baseline, 8-weeks, 12-weeks, and 16-weeks
Masking: None (Open Label)
Primary purpose: Prevention