CompletedNot Applicable

Therapist Education and Massage for Parent Infant-Outcomes

United States68 participantsStarted 2019-11-25

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)

Timeframe: Baseline

Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Percent of Parents Who Complete All Protocol Components (Adherence)

Timeframe: At hospital discharge, approximately 8-16 weeks after enrollment

Percent of Parents Who Are Retained in the Study at 12 Months (Retention)

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Percent of Enrolled Parents Who Provide Complete Data and Interviews

Timeframe: Final follow up visit - an average of 15-18 months after study period begins

Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities

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

Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure

Timeframe: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)

Trial details

NCT IDNCT04121897

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-01

Results submitted2023-02-09

View on ClinicalTrials.gov More Parent-Child Relations trials