University of North Carolina Children's Hospital
Chapel Hill, North Carolina, 27759, United States
NCT Number: NCT04121897
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.
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Interventional
Not applicable
Chapel Hill, North Carolina, 27759, United States
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.
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:
o At this visit, the therapist will have the parent fill out a questionnaire for ongoing measurement.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TEMPO includes these components:
Time frame: Baseline
Recruitment is defined as the percent of eligible participants enrolled of those approached.
Time frame: 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.
Time frame: At hospital discharge, approximately 8-16 weeks after enrollment
The percent of enrolled parents who complete all protocol components during hospitalization.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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)
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: 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?".
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. 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. 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.
Time frame: 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.
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)
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)
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)
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)
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: 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.
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
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
University of North Carolina, Chapel Hill
Other
TEMPO: A Feasibility Study of a Therapist-led Program for Parents of Extremely Pre-term Infants
Acronym: TEMPO
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