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临床试验/NCT06179576
NCT06179576招募中不适用

Connect to Baby: A Pilot Study of a Parenting and Coparenting Program for New Parents

Georgetown University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
2
主要终点
Coparenting Relationship Scale

研究概览

简要总结

The proposed project is a randomized control trial to assess a novel 6-session parenting and coparenting intervention for low-income parents of infants. Connect to Baby (CTB) will be implemented within one of the largest federally-funded early care and education programs, Early Head Start (EHS), in Washington, DC. To engage both fathers and mothers, CTB recruits parents at the time of birth, capitalizing on the "magic moment" of delivery, and uses father-inclusive digital media content to engage men. A key innovation lies in the introduction and rehearsal of four interaction skills -- Noticing, Following, Talking, and Encouraging (NiFTE, pronounced "Nifty") -- to foster serve-and-return interactions with infants as well as supportive, cooperative coparenting interactions between mothers and fathers. To maximize program uptake, CTB is situated within an early education program parents already trust and attend. Additionally, the study will test hybrid program delivery with both in-person and remote sessions using video-enabled tablets to reduce scheduling and logistical barriers and thereby enhance retention. The specific aims of the project are to assess efficacy of random assignment to Hybrid delivery of CTB relative to EHS as usual at enhancing parenting and coparenting quality and parent and child wellbeing. If demonstrated to be efficacious, this program will provide Early Head Start (and other family-serving agencies) a brief cost-effective, manualized preventive intervention that could be used alone or in conjunction with other services to improve parent functioning and co-parenting, further engage fathers in programming and caregiving, and, ultimately, enhance child development.

详细描述

Overview:

The proposed project is a randomized control trial to assess the effectiveness of a novel 6-session parenting and coparenting intervention for low-income parents of infants designed by the program developers of Just Beginning (JB) and Family Foundations (FF). Connect to Baby (CTB) blends and builds upon these two evidence-based programs and will be implemented within one of the largest federally-funded early care and education programs, Early Head Start (EHS), in Washington, DC. CTB's approach recognizes that although many existing interventions aim to increase parenting quality in low-income contexts, the vast majority yield only modest effects that often fade. These mixed findings stem, in part, from three key weaknesses in existing programs: 1) a focus on mothers, rather than mothers and fathers; 2) a focus on the parent-child relationship to the exclusion of the coparenting relationship; 3) low program recruitment and retention rates. The co-PIs have successfully piloted a program that addresses these weaknesses and can be easily incorporated into programs like EHS to enhance their effects on parenting, and child development. Specifically, to engage both fathers and mothers, CTB recruits parents at the time of birth, capitalizing on the "magic moment" of delivery, and uses father-inclusive digital media content to engage men. A key innovation lies in the introduction and rehearsal of four interaction skills -- Noticing, Following, Talking, and Encouraging (NiFTE, pronounced "Nifty") -- to foster serve-and-return interactions with infants as well as supportive, cooperative coparenting interactions between mothers and fathers. To maximize program uptake, CTB is situated within an early education program parents already trust and attend. Additionally, the study will test hybrid program delivery with both in-person and remote sessions using video-enabled tablets to reduce scheduling and logistical barriers and thereby enhance retention. CTB has two key targets of intervention - coparenting communication and parenting quality. By enhancing these targets, CTB aims to improve parent mental health, and child socioemotional and language outcomes. The specific aims of the project are to assess efficacy of random assignment to Hybrid delivery of CTB relative to EHS as usual at enhancing program targets and both parent mental health and infant socioemotional and language outcomes. If demonstrated to be efficacious, this program will provide Early Head Start (and other family-serving agencies) a brief cost-effective, manualized preventive intervention that could be used alone or in conjunction with other services to improve parent functioning and co-parenting, further engage fathers in programming and caregiving, and, ultimately, enhance child development.

Families will be randomly assigned to CTB-EHS Hybrid and EHS-digital only conditions. There will be 100 dyads randomly assigned to each condition. The main objective of the study is to test the feasibility of the CTB-Hybrid intervention for enhancing targets of co-parenting and parenting, and outcomes of parent well-being and child language and socioemotional development. The specific aims are:

Aim 1. To assess the efficacy of CTB-Hybrid at improving program targets. One hundred and fifty families will be recruited and randomized to one of two conditions: 1) EHS-CTB Hybrid or 2) EHS-digital with CTB digital content (content delivered via the customized application). CTB is hypothesized to increase coparenting communication quality and parenting quality relative to EHS digital at 3- and 6-months post-random assignment (RA); comparing results at each time point will distinguish immediate from sustained effects of the program. Analyses will include both intent-to-treat (ITT) and treatment-on-the-treated (TOT) analyses to determine the importance of program dosage for program efficacy.

Aim 2. To assess the efficacy of CTB-Hybrid at enhancing secondary program outcomes. CTB will also be assessed with regard to parent mental health (assessed using parent self-report and a short diagnostic interview at 3- and 6-months post (RA), and child socioemotional and language outcomes at 3- and 6-months post RA (assessed using parent-report and objective ratings). In exploratory analyses, parenting and coparenting quality will be tested as mediators and child sex as moderator of effects on secondary outcomes.

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

Families will be randomly assigned to the treatment or control condition upon enrollment in the study. Because it is an intervention, administered by facilitators, the facilitators and parents will be aware of the treatment families status. The investigators will know which families are receiving the treatment or not because they will need to manage the progress of the intervention and the progress of data collection. Those blind to treatment status will be the data collectors, who will administer all parent surveys and objective measures, including the videotaped parent-child interactions. The coders of the videotaped parent-child interactions will also be blind to treatment status.

入排标准

年龄范围
2 Months 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Must be a mother, father (or father figure, including same sex parent and grandparent) of an infant who is 2-24 months.
  • Must speak and read English or Spanish with sufficient fluency for completion of consent forms and questionnaires and actively participate in the intervention.

排除标准

  • Pre-intervention assessment their score on the Woman Abuse Screening Tool (WAST) Interpersonal Violence (IPV) screener (Brown, Lent, Schmidt, & Sas, 2000) indicates sexual or physical abuse.

结局指标

主要结局

Coparenting Relationship Scale

时间窗: 6 months

Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.

Parent criticizes child during parent-child interactions

时间窗: 6 months

Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

Parent restricts child during parent-child interactions

时间窗: 6 months

Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

Coparenting Quality: competition

时间窗: 6 months

Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

Father Engagement Scale

时间窗: 6 months

Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4

Parent Descriptive Language during parent-child interactions

时间窗: 6 months

Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

Coparenting Quality:mother-father pleasure in coparenting

时间窗: 6 months

Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

Coparenting Quality: cooperation

时间窗: 6 months

Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

Parent Acceptance/Warmth during parent-child interactions

时间窗: 6 months

Positive parenting behaviors as coded from a 25 minute parent-child interaction

Parent Follows child's lead during parent-child interactions

时间窗: 6 months

Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

Parent Extends Child's Focus during parent-child interactions

时间窗: 6 months

Qualitative rating (0-4 scale) as coded from a 25 minute parent-child interaction

Coparenting Quality: interactiveness

时间窗: 6 months

Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

Coparenting Quality: displeasure in coparenting

时间窗: 6 months

Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

次要结局

  • Parent mental health(6 months)
  • Parent self efficacy(6 months)
  • Child language development(6 months)
  • Child socioemotional development(6 months)
  • Parent Generalized Anxiety Scale(6 months)
  • Child Language Development(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca Ryan

Professor

Georgetown University

研究点 (2)

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