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临床试验/NCT02093052
NCT02093052Unknown1 期

Intervening Early With Neglected Children: Key Childhood Outcomes

University of Delaware1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2005年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
220
试验地点
1
主要终点
Inhibitory control

研究概览

简要总结

This study will assess early and middle childhood outcomes of an intervention for neglecting parents that was implemented in the children's infancy. We expect that parents who received the Attachment and Biobehavioral Catch-up Intervention in infancy will be more nurturing and will follow children's lead more than parents who received a control intervention, and that children will show better outcomes in attachment, inhibitory control, emotion regulation, and peer relations than children of parents who received the control intervention.

详细描述

Children were randomly assigned to receive the ABC intervention or a control intervention (DEF) in infancy. These two groups, plus a group of low-risk children, will be studied in early and middle childhood. Of interest will be differences in parent and child outcomes that result from the intervention.

Hypothesis 1: Neglected children whose parents received the ABC intervention and low-risk comparison children will show better inhibitory control than neglected children whose parents received the DEF intervention.

Hypothesis 2: Children in the ABC intervention condition and low-risk comparison children will show better emotion regulation than children in the DEF condition.

Hypothesis 3: Children in the ABC intervention condition and comparison children will show less reactive aggression and less hostile attributional bias than children in the DEF condition.

Hypothesis 4: Children in the ABC condition and comparison children will show more normative cortisol production than children in the DEF condition.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •must have been in earlier randomized clinical trial

排除标准

  • 未提供

研究组 & 干预措施

Attachment and Biobehavioral Catch-up

Experimental

Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead

干预措施: Attachment and Biobehavioral Catch-up (Behavioral)

Low-risk

No Intervention

Low-risk comparison group

Developmental Education for Families

Active Comparator

Developmental Education for Families - 10 session intervention that targets cognitive development

干预措施: Developmental Education for Families (Behavioral)

结局指标

主要结局

Inhibitory control

时间窗: Child age of 36 months

DB-DOS- children who successfully do not touch forbidden toys

Emotion regulation

时间窗: Child age of 36 months

Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)

Cortisol production

时间窗: Child age of 10

Salivary cortisol levels collected at wake-up and bedtime

Attachment

时间窗: Age 18 months

Attachment assessed through Strange Situation

Child diagnosis

时间窗: Child age of 10

Parents will complete diagnostic interview.

Peer relations

时间窗: Child age of 10 years

Social information processing will be assessed through children's responses to videos of peer provocations.

Child aggression

时间窗: Child age of 10

Children will complete video game that will allow assessment of reactive and proactive aggression.

Cortisol production

时间窗: Child age of 24 months

Salivary cortisol levels collected at wake-up and bedtime

Cortisol production

时间窗: Child age of 8

Salivary cortisol levels collected at wake-up and bedtime

次要结局

  • Parent neural activity assessed through event related potentials(Child age 4)
  • Parent Attachment Script Knowledge(Child age of 9)
  • Child inhibitory control in middle childhood(Child age 8)
  • Child attachment security (self-reported on Kerns' Attachment Inventory)(Child age 10)
  • Parental sensitivity(Child age of infancy (12-24 months child age))
  • Child attachment security (narrative measure)(Child age 9)
  • Autonomic nervous system activity(Child age 10)
  • Child brain activity(Child age 9)
  • Alpha and theta wave(Child age 9)
  • Round Robin Assessment of Peer Rejection(Child age 9)
  • Parental sensitivity using Parent-Child Interaction Coding System(Child age 9)
  • Body mass index(Age 4)
  • Autonomic nervous system activity(Child age 8)
  • Child attachment security (self-reported on Kerns' Attachment Inventory)(Child age 9)
  • Body mass index(Age 3)

研究者

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

Mary Dozier

Principal Investigator

University of Delaware

研究点 (1)

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