Extreme Prematurity, Parent-Child Relations, Parents
Conditions
Brief summary
The Therapist Education and Massage for Parent-Infant Outcomes program is evidence-based and includes infant massage, physical therapy interventions including developmental support and play activities to promote infant behavioral-motor development, principles of family-centered care, and multiple modes of educational delivery to enhance parent retention of knowledge, parent-infant bonding, and confidence in continuing physical therapy interventions after discharge.
Detailed description
The Therapist Education and Massage for Parent-Infant Outcomes program involves components during and after hospitalization. During infant hospitalization • Visit 1: Early Parent Education Session: Initiated within 3 weeks of infant birth. The therapist will educate the parent about the importance of infant positioning, the impact of prematurity on the motor and sensory systems, and how to read and respond to infant behavioral-motor cues using a written pamphlet with pictures to supplement the verbal education lasting about 30 minutes. * The therapist will ask the parent to complete a contact information form and a demographic form and a baseline questionnaire. * Visits 2-8: Weekly Parent Education Sessions \<34 weeks: Following the initial parent education session, the therapist will hold weekly parent education sessions, ideally at the time of therapy. When the infant is this young (\<34 weeks gestation), therapist intervention and education will focus on infant behavioral-motor cues, reading/response to infant cues, positioning strategies/concerns, and developmentally appropriate stimulation of the infant. If the parent is not available for all therapy sessions, then the parent will receive a weekly update about their infant's progress face-to-face and/or via video chat. * Visits 9-10: Infant Massage Parent Education Sessions: Parent-administered infant massage will be incorporated into the therapy plan of care as soon as the infant's medical provider determines that the infant is physiologically stable and can tolerate massage. This time is generally once the infant is approximately 34 weeks gestational age, approximately 1500 grams, and is demonstrating temperature stability out of the isolette for short periods. At a minimum, the therapist will teach massage for the back or lower extremities over 2 parent education sessions. The therapist will demonstrate massage strokes on a doll using verbal cues to guide the parent while the parent administers massage on the infant. An instructional massage pamphlet will be provided. Once the therapist has determined parent safety with massage administration, parents will be encouraged to practice infant massage when they visit the baby and to note when they do this by marking a card at the bedside. * Pre and Post both massage sessions, the Primary Investigator or study coordinator will collect salivary cortisol via buccal swab as a measure of physiologic stress. * Visits 11+: Weekly Parent Education Sessions \>34 weeks: Weekly parent education once the infant is \>34 weeks will begin to incorporate hands-on developmental play activities, introduction to visual engagement, and postural control practice in variety of positions that the infant tolerates. Additionally, the therapist and parent may choose to review massage at these visits. If the parent is not available for all therapy sessions, then the parent will receive a weekly update about their infant's progress face-to-face and/or via video chat. * Final Visit during hospitalization: Within the week of hospital discharge, the therapist will schedule a face-to-face parent education session lasting about 30 minutes to review age-appropriate developmental play activities for home and review infant massage. A supplemental handout and therapist email and pager information will be provided. * At this visit, the therapist will have the parent fill out a questionnaire. Follow- up procedures (by visits) The program has additional components that extend beyond the hospital period. Parent and infant outcome measures will be collected at the first follow-up and 12 month corrected age follow-up clinic visits. After hospitalization: * Visit 1: Parent Education Post-Discharge: The therapist will call the parent within 2 weeks of discharge to follow up about discharge education and massage. During this phone call, the therapist will review the home program and massage techniques. The therapist will also answer any parent questions. Therapist email and pager information will be provided. * Visits 2-12 (approximate): Bi-weekly emails (or texts): The therapist will send bi-weekly emails or texts (depending on parents' preference) with developmental play activity and massage reminders and tips from hospital discharge through the first follow up appointment. * Visit 13 (approximate): First Visit Follow-up Massage Review Session: At the infant's first follow-up appointment with the multidisciplinary neonatology team, the therapist will provide a gross motor screening assessment and education. In addition, as part of the program, a therapist will facilitate a parent-administered infant massage session to provide an opportunity for parent to receive feedback on technique from the therapist. This session will address any safety concerns, infant changes, and parent questions. o At this visit, the therapist will have the parent fill out a questionnaire for ongoing measurement. * Visits 14+ (approximate): Bi-weekly emails (or texts): The therapist will continue to send bi-weekly emails or texts (depending on parents' preference) with developmental play activity and massage reminders until the 12 month followup appointment. * 12 Month Follow-up Appointment: At the standard of care 12 month corrected age follow-up appointment with the multidisciplinary neonatology team, the PI or study coordinator will interview the parent about acceptability of the program. * At this visit, the therapist will have the parent fill out a questionnaire for ongoing measurement
Interventions
OTHERTherapist Education and Massage for Parents of Extremely Preterm Infants
TEMPO includes these components: * Early Parent Education Session * Weekly Parent Education Sessions * Infant Massage Parent Education Sessions * Discharge Parent Education Session * Parent Education Post-Discharge * Bi-weekly emails (or texts) * 2 Month Follow-up Massage Review Session
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective single group
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Infants with gestational age \<28 weeks gestation, within the first 3 weeks of life, and their * Biologic mother or father must be able to speak and understand English.
Exclusion criteria
* Infants who do not have a biological parent available to consent within the first 3 weeks of life. * Infants with genetic/chromosomal abnormality, congenital neurological or musculoskeletal disorder, or abnormal bone density related to a congenital condition that would affect the ability to do massage and/or exercise and the safety of the infant. * Parents who are unwilling to engage in all components of TEMPO.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Summaries of Parent Experience Via Interview | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins | The Primary Investigator or research coordinator will conduct interviews with parents at both follow up visits using 3 questions developed by the Primary Investigator to assess feasibility, acceptability, and perceived benefit of massage. Yes/No responses were provided for the following questions: (1) Was it difficult to meet the therapist weekly for TEMPO sessions?; (2) Would you recommend TEMPO to other parents of preterm infants?; and (3) Have you continued doing massage with your baby at home?. |
| Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) | Baseline | Recruitment is defined as the percent of eligible participants enrolled of those approached. |
| Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants | Final follow up visit - an average of 15-18 months after study period begins | The percent of enrolled parents who report they would recommend the program to other parents. |
| Percent of Parents Who Complete All Protocol Components (Adherence) | At hospital discharge, approximately 8-16 weeks after enrollment | The percent of enrolled parents who complete all protocol components during hospitalization. |
| Percent of Parents Who Are Retained in the Study at 12 Months (Retention) | Final follow up visit - an average of 15-18 months after study period begins | Percent of enrolled parents who are retained in the study at 12 months. |
| Percent of Enrolled Parents Who Provide Complete Data and Interviews | Final follow up visit - an average of 15-18 months after study period begins | The percent of enrolled parents who provide complete data and interviews. |
| Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities | at First follow up visit - approximately 1 to 2 months after hospital discharge | The average days per week that parents completed TEMPO activities based on parents' weekly self reports. |
| Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Longitudinal measures of parents' perceived acceptability of intervention throughout the study period measured by the percent of parents who rate acceptability as 4/5 or 5/5 using the Acceptability of Intervention Measure. The Acceptability of Intervention Measure is a 12 item implementation outcome assessment designed to measure if the intervention is perceived as agreeable, palatable, or satisfactory. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability. |
| Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Longitudinal measures of parents' perceived feasibility of intervention throughout the study period measured by the percent of parents who rate feasibility as 4/5 or 5/5 using the Feasibility of Intervention Measure. The Feasibility of Intervention Measure is a 9 item implementation outcome assessment designed to measure the extent to which a new treatment can be successfully used or carried out. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Infant Salivary Cortisol Level | To be measured twice immediately pre-and post initial massage education in the hospital. | Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. |
| Parent Salivary Cortisol Level | To be measured twice immediately pre-and post initial massage education in the hospital. Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress 15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. Paired t-tests were conducted to assess pre- to post-infant massage cortisol levels in parents. |
| Bayley Scales of Infant Development IV | Final follow up visit - an average of 15-18 months after study period begins | The Bayley Scales of Infant Development IV (BSID-IV) is a standardized assessment to evaluate cognitive development, expressive and receptive language, and fine and gross motor development in children between the ages of 1 and 42 months. For the purpose of this study, only the gross motor scale was recorded. For infants at approximately 12 months corrected, the total gross motor scaled scores range from 0-19 with 0 indicating the highest risk of developmental delay and 19 indicating the lowest risk of developmental delay. |
| Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Sample medians and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. An 8 item validated measure with each item rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety. |
| Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A valid, reliable self-assessment tool for evaluating depressive symptoms in adult populations, including among mothers during and after parturition. The 20 item form will be used. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology. |
| Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 10-item self-report questionnaire validated to detect change in depressive symptoms in mothers both during and after the postnatal period. Scores range from 0-30, with scores greater than 13 indicating likely depressive illness. |
| Longitudinal Measures Changes in Parenting Sense of Competence Scale | Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months) | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 17-item scale using ratings (Strongly Disagree-1, Somewhat Disagree-2, Disagree-3, Agree-4, Somewhat Agree-5, Strongly Agree-6) to assess satisfaction of parenting and parental self-efficacy in a variety of populations with a range in score from 17 to 102 and higher scores indicating a greater sense of parental self-efficacy. |
| Postnatal Attachment Questionnaire | Final follow up visit - an average of 15-18 months after study period begins | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A Maternal Postnatal Attachment Scale (MPAS) with 19 items representing 4 components: pleasure in proximity, tolerance, need-gratification and protection, and knowledge acquisition was used to query the parents' feelings about their infants under 1 year of age. The MPAS is a self-reported scale to reflect the degree of subjective emotional connection between mothers and their infants.The scale includes two, three, four and five options.The total score span of the scale is between 19-95, and the higher the score, the higher the level of maternal and child attachment. |
| Longitudinal Measures in Infant Temperament Using Carey Temperament Scales | First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins | Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. This questionnaire assesses nine temperamental characteristics of infants. Caregivers are presented with a statement describing a certain behavior and asked to rate how often their child behaves in that way on a scale from 1 (almost never) to 6 (almost always), with higher scores indicating more difficult temperament |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TEMPO Parents The Therapist Education and Massage for Parent-Infant Outcomes program (TEMPO) is a structured, therapist-led physical therapy program. TEMPO trains and supports parents to deliver physical therapy interventions including massage and developmental play during hospitalization and in the home setting.
Therapist Education and Massage for Parents of Extremely Preterm Infants: TEMPO includes these components:
* Early Parent Education Session
* Weekly Parent Education Sessions
* Infant Massage Parent Education Sessions
* Discharge Parent Education Session
* Parent Education Post-Discharge
* Bi-weekly emails (or texts)
* 2 Month Follow-up Massage Review Session | 32 |
| TEMPO Infants Physical Therapy (PT) and Occupational Therapy (OT) Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable)
* PT and OT Intervention at \<33 weeks Post Menstrual Age (PMA): During hospitalization, infants received PT and OT intervention 4-5 times weekly (total) for approximately 15-30 minutes at a time.
* PT and OT Re-assessment: Performed between 33-34 weeks PMA if infant was physiologically stable.
* PT and OT Intervention \>33 weeks PMA: Infants continued to receive combined PT or OT intervention 4-5 times weekly for approximately 30 minutes.
* Discharge Education: In standard of care therapy, the PT or OT reviewed a 2-page handout with the parent if they are available at the bedside the week of discharge.
* \<4 month and 12-month Follow-Up Visits: The Special Infant Care Clinic is a multidisciplinary follow-up clinic that follows the neurodevelopment of preterm infants discharged from the Neonatal Critical Care Center (NCCC). | 36 |
| Total | 68 |
Baseline characteristics
| Characteristic | TEMPO Infants | Total | TEMPO Parents |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 36 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 32 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 60 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) White | 20 Participants | 37 Participants | 17 Participants |
| Region of Enrollment United States | 36 Participants | 68 Participants | 32 Participants |
| Sex: Female, Male Female | 20 Participants | 51 Participants | 31 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 36 |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities
The average days per week that parents completed TEMPO activities based on parents' weekly self reports.
Time frame: at First follow up visit - approximately 1 to 2 months after hospital discharge
Population: Includes number of parents interviewed at first Follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEMPO Parents | Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities | 4.5 days per week | Standard Deviation 1.5 |
Primary
Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)
Recruitment is defined as the percent of eligible participants enrolled of those approached.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEMPO Parents | Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) | 91 percentage of participants |
Primary
Percent of Enrolled Parents Who Provide Complete Data and Interviews
The percent of enrolled parents who provide complete data and interviews.
Time frame: Final follow up visit - an average of 15-18 months after study period begins
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEMPO Parents | Percent of Enrolled Parents Who Provide Complete Data and Interviews | 56 percentage of participants |
Primary
Percent of Parents Who Are Retained in the Study at 12 Months (Retention)
Percent of enrolled parents who are retained in the study at 12 months.
Time frame: Final follow up visit - an average of 15-18 months after study period begins
Population: More parents agreed to a phone interview than those who agreed to return their child for testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEMPO Parents | Percent of Parents Who Are Retained in the Study at 12 Months (Retention) | 56 percentage of participants |
Primary
Percent of Parents Who Complete All Protocol Components (Adherence)
The percent of enrolled parents who complete all protocol components during hospitalization.
Time frame: At hospital discharge, approximately 8-16 weeks after enrollment
Population: Six parents transferred to an outside hospital and 3 infants died prior to hospital discharge; therefore, 23 dyads were maintained at hospital discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEMPO Parents | Percent of Parents Who Complete All Protocol Components (Adherence) | 87 percentage of participants |
Primary
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure
Longitudinal measures of parents' perceived acceptability of intervention throughout the study period measured by the percent of parents who rate acceptability as 4/5 or 5/5 using the Acceptability of Intervention Measure. The Acceptability of Intervention Measure is a 12 item implementation outcome assessment designed to measure if the intervention is perceived as agreeable, palatable, or satisfactory. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater acceptability.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Data reported for all parents who responded to surveys at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Baseline | 81 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Hospital Discharge | 95 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | First Follow Up | 100 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure | Second Follow Up | 91 percentage of participants |
Primary
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure
Longitudinal measures of parents' perceived feasibility of intervention throughout the study period measured by the percent of parents who rate feasibility as 4/5 or 5/5 using the Feasibility of Intervention Measure. The Feasibility of Intervention Measure is a 9 item implementation outcome assessment designed to measure the extent to which a new treatment can be successfully used or carried out. Cut-off scores for interpretation are not yet available; however, higher scores indicate greater feasibility.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Data reported for all parents who responded to surveys at the specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Baseline | 78 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Hospital Discharge | 100 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | First Follow Up | 100 percentage of participants |
| TEMPO Parents | Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure | Second Follow Up | 91 percentage of participants |
Primary
Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants
The percent of enrolled parents who report they would recommend the program to other parents.
Time frame: Final follow up visit - an average of 15-18 months after study period begins
Population: Includes all parents who were retained through the final Follow Up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TEMPO Parents | Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants | 100 percentage of participants |
Primary
Qualitative Summaries of Parent Experience Via Interview
The Primary Investigator or research coordinator will conduct interviews with parents at both follow up visits using 3 questions developed by the Primary Investigator to assess feasibility, acceptability, and perceived benefit of massage. Yes/No responses were provided for the following questions: (1) Was it difficult to meet the therapist weekly for TEMPO sessions?; (2) Would you recommend TEMPO to other parents of preterm infants?; and (3) Have you continued doing massage with your baby at home?.
Time frame: First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins
Population: Responses reported for participants who answered yes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TEMPO Parents | Qualitative Summaries of Parent Experience Via Interview | Feasibility | 95 percentage of participants |
| TEMPO Parents | Qualitative Summaries of Parent Experience Via Interview | Acceptability | 100 percentage of participants |
| TEMPO Parents | Qualitative Summaries of Parent Experience Via Interview | Perceived benefit | 95 percentage of participants |
Secondary
Bayley Scales of Infant Development IV
The Bayley Scales of Infant Development IV (BSID-IV) is a standardized assessment to evaluate cognitive development, expressive and receptive language, and fine and gross motor development in children between the ages of 1 and 42 months. For the purpose of this study, only the gross motor scale was recorded. For infants at approximately 12 months corrected, the total gross motor scaled scores range from 0-19 with 0 indicating the highest risk of developmental delay and 19 indicating the lowest risk of developmental delay.
Time frame: Final follow up visit - an average of 15-18 months after study period begins
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TEMPO Parents | Bayley Scales of Infant Development IV | 11.6 score on a scale |
Secondary
Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 10-item self-report questionnaire validated to detect change in depressive symptoms in mothers both during and after the postnatal period. Scores range from 0-30, with scores greater than 13 indicating likely depressive illness.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEMPO Parents | Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Baseline | 17.2 score on a scale | Standard Deviation 2.19 |
| TEMPO Parents | Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Hospital Discharge | 18.36 score on a scale | Standard Deviation 2.1 |
| TEMPO Parents | Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | First Follow Up | 18.7 score on a scale | Standard Deviation 2.18 |
| TEMPO Parents | Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale | Second Follow Up | 19.2 score on a scale | Standard Deviation 2.18 |
Secondary
Longitudinal Measures Changes in Parenting Sense of Competence Scale
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A 17-item scale using ratings (Strongly Disagree-1, Somewhat Disagree-2, Disagree-3, Agree-4, Somewhat Agree-5, Strongly Agree-6) to assess satisfaction of parenting and parental self-efficacy in a variety of populations with a range in score from 17 to 102 and higher scores indicating a greater sense of parental self-efficacy.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEMPO Parents | Longitudinal Measures Changes in Parenting Sense of Competence Scale | Baseline | 76.6 score on a scale | Standard Deviation 9.99 |
| TEMPO Parents | Longitudinal Measures Changes in Parenting Sense of Competence Scale | Hospital Discharge | 82.61 score on a scale | Standard Deviation 9.88 |
| TEMPO Parents | Longitudinal Measures Changes in Parenting Sense of Competence Scale | First Follow Up | 85.0 score on a scale | Standard Deviation 11.88 |
| TEMPO Parents | Longitudinal Measures Changes in Parenting Sense of Competence Scale | Second Follow Up | 87.2 score on a scale | Standard Deviation 10.71 |
Secondary
Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A valid, reliable self-assessment tool for evaluating depressive symptoms in adult populations, including among mothers during and after parturition. The 20 item form will be used. Possible range of scores is 0-60, with the higher scores indicating the presence of more symptomatology.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TEMPO Parents | Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Baseline | 15.4 score on a scale | Standard Deviation 7.59 |
| TEMPO Parents | Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Hospital Discharge | 8.21 score on a scale | Standard Deviation 4.85 |
| TEMPO Parents | Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | First Follow Up | 8.0 score on a scale | Standard Deviation 3.84 |
| TEMPO Parents | Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale | Second Follow Up | 7.83 score on a scale | Standard Deviation 5.46 |
Secondary
Longitudinal Measures in Infant Temperament Using Carey Temperament Scales
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. This questionnaire assesses nine temperamental characteristics of infants. Caregivers are presented with a statement describing a certain behavior and asked to rate how often their child behaves in that way on a scale from 1 (almost never) to 6 (almost always), with higher scores indicating more difficult temperament
Time frame: First follow up visit - an average of 6-10 months after study period begins; Final follow up visit - an average of 15-18 months after study period begins
Population: In order to limit parent burden, the investigators removed this questionnaire from the survey battery.
Secondary
Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety
Sample medians and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. An 8 item validated measure with each item rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of anxiety.
Time frame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Population: Although 32 parents were enrolled, Baseline survey data was only collected for 24 . Hospital discharge data was collected for 19 parents. All data were reported for parents who were not lost to follow up.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| TEMPO Parents | Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Baseline | 20 score on a scale | Standard Deviation 5.28 |
| TEMPO Parents | Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Hospital Discharge | 12 score on a scale | Standard Deviation 4.03 |
| TEMPO Parents | Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | First Follow Up | 10 score on a scale | Standard Deviation 5.27 |
| TEMPO Parents | Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety | Second Follow Up | 9.5 score on a scale | Standard Deviation 3.61 |
Secondary
Mean Infant Salivary Cortisol Level
Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist. Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress15 that may be used to understand the mechanism by which the intervention impacts physiological stress states.
Time frame: To be measured twice immediately pre-and post initial massage education in the hospital.
Population: Both a pre- and post initial massage sample was required to detect \& report change and no sufficient samples were collected for any infant at both timepoints. Insufficient (or immeasurable) samples were collected for all infants across all timepoints.
Secondary
Parent Salivary Cortisol Level
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. Salivary cortisol is a biomarker for stress 15 that may be used to understand the mechanism by which the intervention impacts physiological stress states. Paired t-tests were conducted to assess pre- to post-infant massage cortisol levels in parents.
Time frame: To be measured twice immediately pre-and post initial massage education in the hospital. Buccal swab will be taken immediately pre and post massage implementation during hospitalization at the massage education session with therapist.
Population: Six parents transferred to an outside hospital and 3 infants died prior to hospital discharge; therefore, 23 dyads were maintained at hospital discharge. One additional male parent was excluded from analysis because salivary cortisol is sex-specific.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEMPO Parents | Parent Salivary Cortisol Level | -18.05 ng/dL | Standard Deviation 34.89 |
p-value: 0.024t-test, 2 sided
Secondary
Postnatal Attachment Questionnaire
Sample means and standard deviations will be reported to provide an estimate of population parameters needed for planning a future study. A Maternal Postnatal Attachment Scale (MPAS) with 19 items representing 4 components: pleasure in proximity, tolerance, need-gratification and protection, and knowledge acquisition was used to query the parents' feelings about their infants under 1 year of age. The MPAS is a self-reported scale to reflect the degree of subjective emotional connection between mothers and their infants.The scale includes two, three, four and five options.The total score span of the scale is between 19-95, and the higher the score, the higher the level of maternal and child attachment.
Time frame: Final follow up visit - an average of 15-18 months after study period begins
Population: All data were reported for parents who were not lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TEMPO Parents | Postnatal Attachment Questionnaire | 87.9 score on a scale | Standard Deviation 5.9 |