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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
10
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.
Virginia Commonwealth University
Richmond, Virginia, United States
Ease of recruitment of participants
Number of mother-infant dyads recruited, with a goal of 15
Time frame: 12-months after study opens to enrollment
Track non-participation
Track reasons for non-participation via self-report
Time frame: 16-weeks after start of intervention
Adherence
Adherence will be assessed by tracking the number of times the interventions are used
Time frame: 16-weeks after start of intervention
Data collection completeness
Percent of participants with complete data collection at end of study, with a goal of \>75% of patients
Time frame: 16-weeks after start of intervention
Appraisal of SAFE's degree of inconvenience
The participants appraisal of inconvenience will be measured through a semi-structured interview and will be described qualitatively
Time frame: 16-weeks after start of intervention
Satisfaction with 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.
Time frame: 16-weeks after start of intervention
Change in maternal stress
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
Time frame: Baseline to 16-weeks post-baseline
Changes in mother biological stress
Biological stress will be assessed by changes in salivary cortisol of mother (an indicator of mother and infant stress)
Time frame: Baseline to 16-weeks post-baseline
Changes in infant biological stress
Biological stress will be assessed by changes in salivary cortisol of infant (an indicator of mother and infant stress)
Time frame: Baseline to 16-weeks post-baseline
Changes in mother-infant feeding behaviors
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
Time frame: Baseline to 16-weeks post-baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.