Clinical trial NCT04121897: Therapist Education and Massage for Parent Infant-Outcomes
Official title: TEMPO: A Feasibility Study of a Therapist-led Program for Parents of Extremely Pre-term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Parents
Extreme Prematurity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-10-10
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single group
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)
timeFrame: Baseline
measure: 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
measure: Percent of Parents Who Complete All Protocol Components (Adherence)
timeFrame: At hospital discharge, approximately 8-16 weeks after enrollment
measure: 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
measure: 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
measure: 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
measure: 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)
measure: Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility 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)
measure: Qualitative Summaries of Parent Experience Via Interview
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
Secondary outcomes:
measure: Mean Infant Salivary Cortisol Level
timeFrame: To be measured twice immediately pre-and post initial massage education in the hospital.
measure: Parent Salivary Cortisol Level
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.
measure: Bayley Scales of Infant Development IV
timeFrame: Final follow up visit - an average of 15-18 months after study period begins
measure: Longitudinal Measures in Patient-Reported Outcomes Measurement Information System Adult Profile Short Form - Anxiety
timeFrame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
measure: Longitudinal Measures in Centers for Epidemiologic Studies Depression Scale
timeFrame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
measure: Longitudinal Measures Changes in Edinburgh Postnatal Depression Scale
timeFrame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
measure: Longitudinal Measures Changes in Parenting Sense of Competence Scale
timeFrame: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
measure: Postnatal Attachment Questionnaire
timeFrame: Final follow up visit - an average of 15-18 months after study period begins
measure: Longitudinal Measures in Infant Temperament Using Carey Temperament Scales
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
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Children's Hospital
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Dana McCarty, DPT
role: PRINCIPAL_INVESTIGATOR
References: