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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03664154
Other study ID # HM20013532
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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