TEMPO: A Feasibility Study of a Therapist-led Program for Parents of Extremely Pre-term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities
研究概览
简要总结
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.
详细描述
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.
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The therapist will ask the parent to complete a contact information form and a demographic form and a baseline questionnaire.
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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.
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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.
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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.
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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.
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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.
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At this visit, the therapist will have the parent fill out a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Average Number of Days Per Week That Enrolled Parents Complete TEMPO Activities
时间窗: 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
时间窗: 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 Eligible Dyads Who Would Consent to Enroll (Recruitment)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
Percent of Parents Who Rate Acceptability as 4/5 or 5/5 Using the Feasibility of Intervention Measure
时间窗: 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
时间窗: 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?".
次要结局
- 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 Changes in Edinburgh Postnatal 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))
- 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.)
- Postnatal Attachment Questionnaire(Final follow up visit - an average of 15-18 months after study period begins)
- Longitudinal Measures in Infant Temperament Using Carey Temperament Scales(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)
- Mean Infant Salivary Cortisol Level(To be measured twice immediately pre-and post initial massage education in the hospital.)
- Bayley Scales of Infant Development IV(Final follow up visit - an average of 15-18 months after study period begins)
- 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))
- Longitudinal Measures Changes in Parenting Sense of Competence Scale(Baseline, Hospital Discharge (Variable 8-12 weeks), First Follow up (at 1-2 months post discharge), Second Follow up (at 15-18 months))