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Completed

NCT Number: NCT03664154

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.

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Key information

Conditions

Feeding Behavior Behavior Behavior, Animal Female Urogenital Diseases and Pregnancy Complications Mother-Infant Interaction Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Stress Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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