Therapist Education and Massage for Parent Infant-Outcomes

NCT04121897 | Completed Results DMC

• 2 other identifiers: 19-0282KL2TR002490
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Parents; Extreme Prematurity

Outcome Measures

Primary Outcomes (9)

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

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

  Baseline

• 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.

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

• Percent of Parents Who Complete All Protocol Components (Adherence)

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

  At hospital discharge, approximately 8-16 weeks after enrollment

• 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.

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

• Percent of Enrolled Parents Who Provide Complete Data and Interviews

  The percent of enrolled parents who provide complete data and interviews.

  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

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

  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

  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.

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

• 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.

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

• 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?".

  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

Secondary Outcomes (9)

• Mean Infant Salivary Cortisol Level

  To be measured twice immediately pre-and post initial massage education in the hospital.

• 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.

• Bayley Scales of Infant Development IV

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

• 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)

• 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)

Study Arms (1)

TEMPO

EXPERIMENTAL

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.

Other: Therapist Education and Massage for Parents of Extremely Preterm Infants

Interventions

Therapist Education and Massage for Parents of Extremely Preterm Infants OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of North Carolina Children's Hospital

Chapel Hill, North Carolina, 27759, United States

Location

Related Links

• NIH Data Sharing Policy

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dana McCarty, PT, DPT
• Organization: University of North Carolina at Chapel Hill

dana_mccarty@med.unc.edu

919-843-8792

Study Officials

• Dana McCarty, DPT

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single group

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 10, 2019
• Study Start: November 25, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: NIH expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. Publication is anticipated within one year of the study conclusion.
• Access Criteria: Data use agreement. http://research.unc.edu/clinical-trials/clinical-trials-gov/data-sharing-guidance/

Locations

US (1)