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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664154
• Other study ID #: HM20013532
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: June 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding Behavior
• Mother-Infant Interaction
• Premature Birth
• Preterm Infant
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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

Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. — View Citation

Lazarus, R. S., & Folkman, S. (1984). Stress, Appraisal, and Coping. New York, NY: Springer Publishing.

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

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