The PANTHERS (Parents and iNfants Together in Home-based Early Remote Services) Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- Infant-Toddler Social and Emotional Assessment (ITSEA)
研究概览
简要总结
The PANTHERS (Parents And iNfants Together in Home-based Early Remote Services) Projects is a study funded by the National Institute of Child Health and Human Development to evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. All families will participate in five remote evaluations in their home, and families will also receive 6 remote treatment sessions of either the IBP or the EPPC. All participant procedures will be conducted remotely.
详细描述
Research Design: The proposed study will evaluate the efficacy and maintenance of a remote home-based preventive intervention, the Infant Behavior Program (IBP), to decrease behavior problems in infants from high-risk families. Specifically, the investigators propose to conduct a randomized controlled trial to demonstrate its efficacy and maintenance in reducing behavior problems and increasing infant regulation relative to an enhanced pediatric primary care (EPPC) active control condition. Assessments will occur at pre (week 0)- and post (week 8)-intervention assessments (approximately 2 months apart), as well as at 4-month (week 24) , 8 -month (week 40), and 12-month (week 56) follow-up assessments.
Procedures: Families will be primarily recruited from pediatric primary care centers and will be randomized to receive six sessions of either IBP or EPPC in their home. Families also will participate in five remote home-based assessments.
Risks and Benefits: Families may experience risk from a breach in confidentiality as participants reveal sensitive information and there are risks in breach of confidentiality due to videoconferencing methods, in particular if study staff become aware of abuse or neglect situations. Families may experience discomfort when answering personal questions. Benefits to families could include providing families with information that can assist in caring for their child, and instilling new parenting strategies that are designed to outlast treatment.
Knowledge: This study will provide information about the efficacy of a remote home-based preventive intervention to improve infant behavior and regulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators and coders assessing response over time are kept unaware of the condition to which each participant is assigned.
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants ages 12 to 18 months and at least one primary caretaker, who is at least 18-years-old and in most cases will be the mother
- •Elevated score (> 75th percentile) on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan et al., 2004)
- •An English-speaking or Spanish-speaking primary caregiver.
排除标准
- •Infants with major sensory impairment (e.g., deafness blindness) or several problems that impair mobility (e.g., cerebral palsy)
- •Significant cognitive delay in the primary caregiver (i.e., estimated IQ score < 70 on the vocabulary subtest of the Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II) for those speaking English or an average standard score < 4 on the vocabulary subtest of the Escala de Inteligencia Wechsler Para Adultos - Third Edition (EIWA-III) for those speaking Spanish)
- •Families involved with child protection services, which is expected to be low based on our pilot trials
研究组 & 干预措施
Infant Behavior Program (IBP)
Infant Behavior Program (IBP) is a home-based adaptation of the Child-Directed Interaction (CDI) phase of Parent-Child Interaction Therapy (PCIT), an evidence-based intervention for early externalizing problems. Consistent with recommendations we maintained core features of CDI and addressed the unique developmental needs of infants. All IBP sessions will completed remotely.
干预措施: Infant Behavior Program (IBP) (Behavioral)
Enhanced Pediatric Primary Care (EPPC)
Families in EPPC will receive six one-hour home visits where they will receive information about normative developmental and health expectations for their infant. Specifically, therapists will provide education on six topics: (1) cognitive and emotional development; (2) language and social development; (3) safety; (4) feeding and nutrition; (5) sleep; and (6) fitness and activity. All EPPC sessions will completed remotely.
干预措施: Enhanced Pediatric Primary Care (EPPC) (Other)
结局指标
主要结局
Infant-Toddler Social and Emotional Assessment (ITSEA)
时间窗: Change from week 0 to weeks 8, 24, 40, and 56
The ITSEA is a 166-item parent-report measure of the frequency of specific behaviors (e.g., temper tantrums) in 12- to 36-month-olds. Participants will score their child behavior on a scale of 0-2 (0 Not true/Rarely, 2 Somewhat True/Sometimes and 3 Very True/Often). The higher the score, the higher the child is on behavior problems. The Externalizing scale will be an indicator of infant behavior. The higher the score the higher child's behavior problems.
次要结局
- Brief Infant-Toddler Social Emotional Assessment (BITSEA)(Screen)
- Ages and Stages Questionnaire-Third Edition (ASQ-III)(Week 0)
- The Parenting Stress Index, Fourth Edition Short Form (PSI-SF)(Change from weeks 0 to week 8, 24, 40, and 56)
- Early Childhood Behavior Questionnaire-Very Short Form (ECBQ)(Change from weeks 0 to week 8, 24, 40, and 56)
- Laboratory Temperament Assessment Battery (Lab-TAB)(Change from weeks 0 to week 8, 24, 40, and 56)
- Brief Infant Sleep Questionnaire (BISQ)(Change from weeks 0 to week 8, 24, 40, and 56)
- Screen Media Use Questionnaire A(Week 0)
- Parenting Scale(Change from weeks 0 to week 8, 24, 40, and 56)
- Parental Sensitivity/Responsivity: Global codes from the Early Parenting Coding System (EPCS)(Change from weeks 0 to week 8, 24, 40, and 56)
- Abbreviated Multidimensional Acculturation Scale (AMAS)(Week 0)
- Wechsler Abbreviated Scale of Intelligence Second Edition (WASI-II)(Screen)
- Dyadic Parent-Child Interaction Coding System-IV (DPICS-4)(Change from weeks 0 to week 8, 24, 40, and 56)
- Screen Media Use Questionnaire B(Repeated at weeks 8, 24, 40, and 56.)
- Multidimensional Acculturative Stress Inventory (MASI)(Week 0)
- Short-form version of the MacArthur Communicative Development Inventories(Change from weeks 0 to week 8, 24, 40, and 56)
- Screen Media Use Interview(Repeated at weeks 0, 8, 24, 40, and 56.)
- Positive and Negative Affective Schedule (PANAS)(Change from weeks 0 to week 8, 24, 40, and 56)
- Services for Children and Adolescents-Parent Interview (SCAPI)(Change from weeks 0 to week 8, 24, 40, and 56)
- Therapy Attitude Inventory (TAI)(Week 8)
- Adult Executive Functioning Inventory (ADEXI)(Week 0)
- NIH Cognitive Toolbox List Sorting Working Memory Test(Week 0)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Change from weeks 0 to week 8, 24, 40, and 56)
- COPING WITH TODDLERS' NEGATIVE EMOTION SCALE (CTNES)(Change from weeks 0 to week 8, 24, 40, and 56)
- Technological Ease and Computer-based Habits Inventory (TECHI)(Week 0)
- IBP Quiz(Week 8)
- EPPC Quiz(Week 8)