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临床试验/NCT05562557
NCT05562557招募中不适用

A Regional Partnership for New York City to Improve Well-Being and Child Welfare Outcomes Among Families at Risk of Substance Misuse Through Fatherhood Engagement

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年5月9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
240
试验地点
1
主要终点
Child well-being

研究概览

简要总结

Montefiore will engage fathers in families at risk of substance misuse in the Bronx and neighboring communities. Families will be referred from Bronx and neighboring community-based child welfare systems, substance use disorder (SUD) treatment providers, and medical providers if identified at risk of substance use concerns and will be randomly assigned to receive services as usual as part of the comparison group, or to receive enhanced services as part of the program group.

Enhanced services include: (1) Motivational Enhancement; (2) referral to Healthy, Empowered, Resilient, and Open (HERO) Dads fatherhood engagement program; (3) Contingency Management; and (4) Case Management.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • is a custodial or non-custodial father
  • speaks English or Spanish
  • has at least one child under the age of 18,
  • someone in the family is identified as at-risk for substance use through: self-report of illicit substance use in the family, the presence of an SUD diagnosis in the family, a clinician/provider identified substance use risk, or the presence of a substance-related indicated child welfare allegation in the family

排除标准

  • The placement of all children in the family in foster care

结局指标

主要结局

Child well-being

时间窗: Baseline and 6 Month followup

Child well-being will be assessed by the Child Behavior Checklist. This is a standardized self-report measure widely used in the measure of child behavior and child well-being. Separate forms are used for children aged 1.5-5, and 6-18. The questionnaire is completed by the caregiver using a series of Likert scales (0=absent, 1=sometimes, 2=often occurs). There are 113 questions, measuring a series of internalizing (e.g., anxious/ depressed, depressed, somatic complaints) and externalizing (e.g., attention problems, rule-breaking behavior, aggression) symptoms over the prior 6-months. Raw scores are standardized into t-scores, with elevated scores reflecting greater symptomatology when compared to a gender and aged normed population.

次要结局

  • Father engagement based on the Child-Parent Relationship Scale, Short form (CPRS-SF)(Baseline and 6 Month followup)
  • Father engagement based on the Inventory of Father Involvement, Short form (IFI-SF)(Baseline and 6 Month followup)
  • Father engagement based on the Parenting Alliance Inventory (PAI)(Baseline and 6 Month followup)
  • Father behavioral health based on the Addiction Severity Index (ASI, adapted)(Baseline and 6 Month followup)
  • Father behavioral health based on the Center for Epidemiological Studies Depression Scale (CESD, adapted)(Baseline and 6 Month followup)
  • Father behavioral health based on the Trauma Symptom Checklist-40 (TSC-40)(Baseline and 6 Month followup)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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