Parent-Child RelationsTEMPONCT04121897
Therapist Education and Massage for Parent Infant-Outcomes
A study testing Therapist Education and Massage for Parents of Extremely Preterm Infants in people with Parent-Child Relations and Parents, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Parents, Extreme Prematurity
- What is being tested?
- Therapist Education and Massage for Parents of Extremely Preterm Infants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Children's Hospital
Chapel Hill, North Carolina, 27759
About this study
Official title: TEMPO: A Feasibility Study of a Therapist-led Program for Parents of Extremely Pre-term Infants
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.
Read the 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.
- 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
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Being tested
- Therapist Education and Massage for Parents of Extremely Preterm Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist Education and Massage for Parents of Extremely Preterm InfantsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapist Education and Massage for Parents of Extremely Preterm Infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)
Recruitment is defined as the percent of eligible participants enrolled of those approached.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?".
Measured: 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
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.
Measured: To be measured twice immediately pre-and post initial massage education in the hospital.
Parent Salivary Cortisol Level
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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 Changes in Edinburgh Postnatal Depression Scale
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.
Measured: 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 Changes in Parenting Sense of Competence Scale
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.
Measured: Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months)
Postnatal Attachment Questionnaire
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.
Measured: Final follow up visit - an average of 15-18 months after study period begins
Longitudinal Measures in Infant Temperament Using Carey Temperament Scales
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start25 Nov 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Dana McCarty, DPT, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121897
- Sponsor's protocol ID
- 19-0282
- Other IDs
- KL2TR002490
- Acronym
- TEMPO
- Status last verified
- Mar 2023
- First submitted
- 4 Oct 2019
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the university.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPO: A Feasibility Study of a Therapist-led Program for Parents of Extremely Pre-term Infants
- ClinicalTrials.gov ID
- NCT04121897
- Acronym / sponsor ID
- TEMPO / 19-0282
- Conditions
- Parent-Child Relations, Parents, Extreme Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single group
| Arm | Type | Receives |
|---|---|---|
| TEMPO | Experimental | Other: Therapist Education and Massage for Parents of Extremely Preterm InfantsThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist Education and Massage for Parents of Extremely Preterm InfantsTEMPO 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 | Other | TEMPO |
Primary outcome
Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment)
Time frame: Baseline
Recruitment is defined as the percent of eligible participants enrolled of those approached.
Percent of Parents Who Would Recommend This Program to Other Parents of Preterm Infants
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.
Percent of Parents Who Complete All Protocol Components (Adherence)
Time frame: At hospital discharge, approximately 8-16 weeks after enrollment
The percent of enrolled parents who complete all protocol components during hospitalization.
Percent of Parents Who Are Retained in the Study at 12 Months (Retention)
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.
Percent of Enrolled Parents Who Provide Complete Data and Interviews
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.
Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities
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.
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Acceptability of Intervention Measure
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.
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure
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.
Qualitative Summaries of Parent Experience Via Interview
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?".
9 secondary outcomes
Mean Infant Salivary Cortisol Level
Time frame: To be measured twice immediately pre-and post initial massage education in the hospital.
Parent Salivary Cortisol Level
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.
Bayley Scales of Infant Development IV
Time frame: 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
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 in Centers for Epidemiologic Studies Depression Scale
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 Changes in Edinburgh Postnatal Depression Scale
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 Changes in Parenting Sense of Competence Scale
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)
Postnatal Attachment Questionnaire
Time frame: Final follow up visit - an average of 15-18 months after study period begins
Longitudinal Measures in Infant Temperament Using Carey Temperament Scales
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Data Sharing PolicyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the university.
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A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers
Healthy, 24-Hour Movement Guidelines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana McCarty, DPT principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist Education and Massage for Parents of Extremely Preterm Infants in people with Parent-Child Relations and Parents, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Eligible Dyads Who Would Consent to Enroll (Recruitment) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.