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

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.

Study Overview

• Status: Completed
• Conditions: Stress; Feeding Behavior; Preterm Infant; Mother-Infant Interaction
• Intervention / Treatment: Behavioral: Stress and Feeding (SAFE)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Maternal 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Stress and Feeding (SAFE); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of recruitment of participants	Number of mother-infant dyads recruited, with a goal of 15	12-months after study opens to enrollment
Track non-participation	Track reasons for non-participation via self-report	16-weeks after start of intervention
Adherence	Adherence will be assessed by tracking the number of times the interventions are used	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	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	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.	16-weeks after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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	Baseline to 16-weeks post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Practicability of collecting cortisol	Practicability will be assessed by tracking the number of successfully obtained, transported, processed, and stored cortisol samples	16-weeks after start of intervention

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Lisa F Brown, PhD, RN, Virginia Commonwealth University

Publications and helpful links

General Publications

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
• Als, H. (1986). A synactive model of neonatal behavioral organization: framework for the assessment of neurobehavioral development in the premature infant and for support of infants and parents in the neonatal intensive care environment. Physical & Occupational Therapy in Pediatrics, 6(2-3), 3-53. http://doi.org/10.1080/J006v06n03_02
• Als H, Gilkerson L. The role of relationship-based developmentally supportive newborn intensive care in strengthening outcome of preterm infants. Semin Perinatol. 1997 Jun;21(3):178-89. doi: 10.1016/s0146-0005(97)80062-6.
• Lazarus, R. S., & Folkman, S. (1984). Stress, Appraisal, and Coping. New York, NY: Springer Publishing.
• Pridham KF. Guided participation and development of care-giving competencies for families of low birth-weight infants. J Adv Nurs. 1998 Nov;28(5):948-58. doi: 10.1046/j.1365-2648.1998.00814.x.
• Pridham K, Brown R, Clark R, Limbo RK, Schroeder M, Henriques J, Bohne E. Effect of guided participation on feeding competencies of mothers and their premature infants. Res Nurs Health. 2005 Jun;28(3):252-67. doi: 10.1002/nur.20073.
• Rogoff, B. (1990). Apprenticeship in thinking: Cognitive development in social context. New York: Oxford University Press.
• Rogoff, B. (2003). The cultural nature of human development. New York: Oxford University Press.
• Schroeder M, Pridham K. Development of relationship competencies through guided participation for mothers of preterm infants. J Obstet Gynecol Neonatal Nurs. 2006 May-Jun;35(3):358-68. doi: 10.1111/j.1552-6909.2006.00049.x.
• Wethington, E., Glanz, K., & Schwartz, M. (2015). Stress, coping and health behavior. In K. Glanz, B. K. Rimer, & K. Viswanath (Eds.), Health Behavior: theory, Research & Practice (5th ed., pp. 223-242). San Francisco, CA: Jossey-Bass.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): December 14, 2020

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: HM20013532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No