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临床试验/NCT01240993
NCT01240993已完成不适用

Fostering Mothers' Emotionally-Responsive Parenting

Yale University4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
4
主要终点
Parent Development Interview coded for maternal reflective functioning

研究概览

简要总结

A formal randomized efficacy trial testing the Mothers and Toddlers' program, an attachment-based parenting intervention for mothers enrolled in addiction treatment and caring for young children.

详细描述

Five years ago the investigators were funded to develop the Mothers and Toddlers Program (MTP; R01 DA17294 / Project Period: 8/20/04 - 12/31/09). MTP is the first parenting intervention developed for substance abusing mothers based on the attachment theory. It is also the only parenting intervention for substance abusing mothers that has led to improvement in maternal caregiving sensitivity and responsiveness to infant and toddler distress in observed lab-based interactions. The investigators now have all the research materials to conduct a Stage II randomized clinical trial including a treatment manual, treatment fidelity scales therapist training program and outcome measures. In this Stage II formal efficacy trial, the investigators (1) Introduce new measures of dyadic adjustment and child attachment, (2) Add an 18 week follow up period to test for sustained treatment effects, (3) Measure major constructs (reflective functioning, representations, dyadic adjustment, and child attachment) when they are expected to change, (4) Examine temporal mechanisms of change proposed in the MTP treatment model (5) Determine whether improvements in dyadic adjustment reduces incidence of relapse, (6) Broaden the MTP therapist pool by training four new therapists and (7) Broaden the coding pool by training 3 additional coders per measure. One hundred and fifty mothers caring for children ages 12 to 60 months of age will be recruited from outpatient substance abuse treatment services at the APT Foundation into the intention-to-treat sample and will be randomized to 12 weeks of MTP vs. PEP and followed for 33 weeks.

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
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All mothers ages 21 to 45 years, who are enrolled in treatment at one of the five APT Foundation clinics and caring for a biological child between 12 and 60 months of age will be eligible to participate.

排除标准

  • Severe mental health problems (e.g., suicidal, homicidal, psychosis, thought disorder)
  • Severe cognitive impairment
  • Inability to speak English
  • Target child with serious illness or significant developmental delay (e.g., cognitive, language, or motor).

结局指标

主要结局

Parent Development Interview coded for maternal reflective functioning

时间窗: Change at week 33 (follow up) from baseline

The Parent Development Interview (PDI; Slade, Aber, Berger, Bresgi, \& Kaplan, 2002) was used to measure maternal capacity to mentalize about her own and her child's behavior. The PDI is a 1 hour semi-structured interview designed to elicit the mother's narrative about commonly occurring, emotionally-challenging aspects of parenting. A rating of 1 indicates a absence of recognition of mental states. A rating of 3 indicates a limited capacity to acknowledge mental states. A rating of 5 indicates the presence of a rudimentary capacity for reflective functioning.

次要结局

  • Working Model of the Child Interview (coded for representation quality)(Change at week 33 (follow up) from baseline)
  • NCAST Teaching Scales (Maternal Behavior)(Change at week 33 (follow up) from baseline)
  • Brief Symptom Inventory(Change at week 33 (follow up) from baseline)
  • Curiosity Box Paradigm(Change at week 33 (follow up) from baseline)
  • Beck Depression Inventory(Change at week 33 (follow up) from baseline)
  • NCAST Teaching Scales (Child Behavior)(Change at week 33 (follow up) from baseline)
  • Child Attachment Status(Change at week 12 (post-treatment) from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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