Stress and Feeding (SAFE): A Pilot Intervention for Mothers and Their Preterm Infants
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|ClinicalTrials.gov Identifier: NCT03664154|
Recruitment Status : Active, not recruiting
First Posted : September 10, 2018
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Feeding Behavior Preterm Infant Stress Mother-Infant Interaction||Behavioral: Stress and Feeding (SAFE)||Not Applicable|
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.
|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)|
|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|
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.
- 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
- Track non-participation [ Time Frame: 16-weeks after start of intervention ]Track reasons for non-participation via self-report
- Adherence [ Time Frame: 16-weeks after start of intervention ]Adherence will be assessed by tracking the number of times the interventions are used
- 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
- 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
- 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.
- 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
- 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)
- 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)
- 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
- 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
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
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Lisa F Brown, PhD, RN||Virginia Commonwealth University|