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

NCT03664154 | Completed

• 1 other identifier: HM20013532
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Behavior; Preterm Infant; Stress; Mother-Infant Interaction

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Change in maternal stress

  Baseline to 16-weeks post-baseline

• Changes in mother biological stress

  Baseline to 16-weeks post-baseline

• Changes in infant biological stress

  Baseline to 16-weeks post-baseline

• Changes in mother-infant feeding behaviors

  Baseline to 16-weeks post-baseline

Other Outcomes (1)

• Practicability of collecting cortisol

  16-weeks after start of intervention

Study Arms (1)

Stress and Feeding (SAFE)

EXPERIMENTAL

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)

Interventions

Stress and Feeding (SAFE) BEHAVIORAL

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.

Stress and Feeding (SAFE)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women who have given birth to a premature infant (either male or female)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• Grade III or IV intraventricular hemorrhage
• Surgical necrotizing enterocolitis

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (10)

• 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

  BACKGROUND

• 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.

  PMID: 9205974 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9840866 BACKGROUND

• 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.

  PMID: 15884024 BACKGROUND

• Jung JW. Apprenticeship in thinking: cognitive development in social context (barbara rogoff). Korean J Med Educ. 2009 Jun;21(2):197-8. doi: 10.3946/kjme.2009.21.2.197. Epub 2009 Jun 30. No abstract available.

  PMID: 25813118 BACKGROUND

• Rogoff, B. (2003). The cultural nature of human development. New York: Oxford University Press.

  BACKGROUND

• 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.

  PMID: 16700685 BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 16204405 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior; Premature Birth

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Lisa F Brown, PhD, RN

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A one-group longitudinal repeated measures design. Data will be collected at baseline, 8-weeks, 12-weeks, and 16-weeks

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 10, 2018
• Study Start: May 15, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 14, 2020
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)