Trial Outcomes & Findings for Therapist Education and Massage for Parent Infant-Outcomes (NCT NCT04121897)

Results Overview

Recruitment is defined as the percent of eligible participants enrolled of those approached.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

Baseline

Results posted on

2023-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	TEMPO 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
Overall Study STARTED	68
Overall Study Parents	32
Overall Study Infants	36
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Therapist Education and Massage for Parent Infant-Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TEMPO Parents n=32 Participants 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	TEMPO Infants n=36 Participants 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).	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	36 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	0 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	20 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	32 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	36 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Recruitment is defined as the percent of eligible participants enrolled of those approached.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=35 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)	91 percentage of participants

PRIMARY outcome

Timeframe: 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.

The percent of enrolled parents who report they would recommend the program to other parents.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=18 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants	100 percentage of participants

PRIMARY outcome

Timeframe: 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.

The percent of enrolled parents who complete all protocol components during hospitalization.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=23 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Parents Who Complete All Protocol Components (Adherence)	87 percentage of participants

PRIMARY outcome

Timeframe: 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.

Percent of enrolled parents who are retained in the study at 12 months.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=32 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Parents Who Are Retained in the Study at 12 Months (Retention)	56 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=32 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Enrolled Parents Who Provide Complete Data and Interviews	56 percentage of participants

PRIMARY outcome

Timeframe: at First follow up visit - approximately 1 to 2 months after hospital discharge

Population: Includes number of parents interviewed at first Follow up visit.

The average days per week that parents completed TEMPO activities based on parents' weekly self reports.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=17 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities	4.5 days per week Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=32 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure Baseline	81 percentage of participants
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure Hospital Discharge	95 percentage of participants
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=32 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure Baseline	78 percentage of participants
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure Hospital Discharge	100 percentage of participants
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
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 outcome

Timeframe: 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".

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?".

Outcome measures

Outcome measures
Measure	TEMPO Infants n=19 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Qualitative Summaries of Parent Experience Via Interview Feasibility	95 percentage of participants
Qualitative Summaries of Parent Experience Via Interview Acceptability	100 percentage of participants
Qualitative Summaries of Parent Experience Via Interview Perceived benefit	95 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=22 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Parent Salivary Cortisol Level	-18.05 ng/dL Standard Deviation 34.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=11 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Bayley Scales of Infant Development IV	11.6 score on a scale Interval 7.0 to 13.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=24 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety Baseline	20 score on a scale Standard Deviation 5.28
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=24 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale Baseline	15.4 score on a scale Standard Deviation 7.59
Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale Hospital Discharge	8.21 score on a scale Standard Deviation 4.85
Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale First Follow Up	8.0 score on a scale Standard Deviation 3.84
Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale Second Follow Up	7.83 score on a scale Standard Deviation 5.46

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=24 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale Baseline	17.2 score on a scale Standard Deviation 2.19
Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale Hospital Discharge	18.36 score on a scale Standard Deviation 2.10
Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale First Follow Up	18.7 score on a scale Standard Deviation 2.18
Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale Second Follow Up	19.2 score on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=24 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Longitudinal Measures Changes in Parenting Sense of Competence Scale Baseline	76.6 score on a scale Standard Deviation 9.99
Longitudinal Measures Changes in Parenting Sense of Competence Scale Hospital Discharge	82.61 score on a scale Standard Deviation 9.88
Longitudinal Measures Changes in Parenting Sense of Competence Scale First Follow Up	85.0 score on a scale Standard Deviation 11.88
Longitudinal Measures Changes in Parenting Sense of Competence Scale Second Follow Up	87.2 score on a scale Standard Deviation 10.71

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TEMPO Infants n=12 Participants PT and OT Initial Assessment: Initiated within the first 72-96 hours of life (if infant medically stable) * PT and OT Intervention at \<33 weeks 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 NCCC.
Postnatal Attachment Questionnaire	87.9 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

Adverse Events

TEMPO Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dana McCarty, PT, DPT

University of North Carolina at Chapel Hill

Phone: 919-843-8792

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place