Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03664154
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Feeding Behavior Preterm Infant Stress Mother-Infant Interaction Behavioral: Stress and Feeding (SAFE) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A one-group longitudinal repeated measures design. Data will be collected at baseline, 8-weeks, 12-weeks, and 16-weeks
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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.





Primary Outcome Measures :
  1. Ease of recruitment of participants [ Time Frame: 12-months after study opens to enrollment ]
    Number of mother-infant dyads recruited, with a goal of 15

  2. Track non-participation [ Time Frame: 16-weeks after start of intervention ]
    Track reasons for non-participation via self-report

  3. Adherence [ Time Frame: 16-weeks after start of intervention ]
    Adherence will be assessed by tracking the number of times the interventions are used

  4. Data collection completeness [ Time Frame: 16-weeks after start of intervention ]
    Percent of participants with complete data collection at end of study, with a goal of >75% of patients

  5. Appraisal of SAFE's degree of inconvenience [ Time Frame: 16-weeks after start of intervention ]
    The participants appraisal of inconvenience will be measured through a semi-structured interview and will be described qualitatively

  6. Satisfaction with intervention [ Time Frame: 16-weeks after start of 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.


Secondary Outcome Measures :
  1. Change in maternal stress [ Time Frame: Baseline to 16-weeks post-baseline ]
    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

  2. Changes in mother biological stress [ Time Frame: Baseline to 16-weeks post-baseline ]
    Biological stress will be assessed by changes in salivary cortisol of mother (an indicator of mother and infant stress)

  3. Changes in infant biological stress [ Time Frame: Baseline to 16-weeks post-baseline ]
    Biological stress will be assessed by changes in salivary cortisol of infant (an indicator of mother and infant stress)

  4. Changes in mother-infant feeding behaviors [ Time Frame: Baseline to 16-weeks post-baseline ]
    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


Other Outcome Measures:
  1. Practicability of collecting cortisol [ Time Frame: 16-weeks after start of intervention ]
    Practicability will be assessed by tracking the number of successfully obtained, transported, processed, and stored cortisol samples



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women who have given birth to a premature infant (either male or female)
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664154


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Layout table for investigator information
Principal Investigator: Lisa F Brown, PhD, RN Virginia Commonwealth University

Publications:
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
Lazarus, R. S., & Folkman, S. (1984). Stress, Appraisal, and Coping. New York, NY: Springer Publishing.
Rogoff, B. (2003). The cultural nature of human development. New York: Oxford University Press.
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.

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03664154     History of Changes
Other Study ID Numbers: HM20013532
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications