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Clinical Trials/NCT02093052
NCT02093052
Unknown
Phase 1

Intervening Early With Neglected Children: Key Childhood Outcomes

University of Delaware1 site in 1 country220 target enrollmentMarch 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Conduct Disorder
Sponsor
University of Delaware
Enrollment
220
Locations
1
Primary Endpoint
Emotion regulation
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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. Although we expect that sustained changes in parenting are critical for sustained changes in child behaviors, several alternative models will be tested. First, it is possible that when parents change as a result of the intervention in a child's infancy, there are positive outcomes for children regardless of whether the changes in parenting are sustained. If this is the case, early parenting will mediate the effects of the intervention when controlling for later parenting. Second, if concurrent parenting is what is critical to child functioning, current parenting will mediate intervention effects on child outcomes when controlling for early parenting. Third, longitudinal modeling of both parent and child behaviors allows for analysis of cross-lagged associations using structural equation modeling. Such modeling can examine concurrent and transactional associations between parent and child. We can also examine associations between change at behavioral and biological levels. Longitudinal modeling will be used to examine models of change in parenting behaviors and how those influence child outcomes.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
April 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Dozier

Principal Investigator

University of Delaware

Eligibility Criteria

Inclusion Criteria

  • must have been in earlier randomized clinical trial

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Emotion regulation

Time Frame: Child age of 36 months

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

Cortisol production

Time Frame: Child age of 10

Salivary cortisol levels collected at wake-up and bedtime

Attachment

Time Frame: Age 18 months

Attachment assessed through Strange Situation

Child diagnosis

Time Frame: Child age of 10

Parents will complete diagnostic interview.

Inhibitory control

Time Frame: Child age of 36 months

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

Peer relations

Time Frame: Child age of 10 years

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

Child aggression

Time Frame: Child age of 10

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

Secondary Outcomes

  • 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))
  • Parent neural activity assessed through event related potentials(Child age 4)
  • 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)

Study Sites (1)

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