Overview

This trial is active, not recruiting.

Conditions conduct disorder, adhd, depression
Treatments attachment and biobehavioral catch-up, developmental education for families
Phase phase 1/phase 2
Sponsor University of Delaware
Start date March 2005
End date January 2019
Trial size 220 participants
Trial identifier NCT02093052, NIH R01 74374

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead
attachment and biobehavioral catch-up
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
(Active Comparator)
Developmental Education for Families - 10 session intervention that targets cognitive development
developmental education for families
Enhance children's cognitive development. In-home intervention with parents and children present.
(No Intervention)
Low-risk comparison group

Primary Outcomes

Measure
Inhibitory control
time frame: Child age of 36 (up to 12 months later)
Emotion regulation
time frame: Child age of 36 months (up to 12 months later)
Peer relations
time frame: Child age of 8 and 10 years
Child diagnosis
time frame: Child age of 10 (up to 11 months later)
Child aggression
time frame: Child age of 10

Secondary Outcomes

Measure
Parental sensitivity
time frame: Child age of infancy (12-24 months child age)
Child attachment
time frame: 8-10 years until study completion
Child inhibitory control in middle childhood
time frame: Child age 8 (up to 12 months later)

Eligibility Criteria

Male or female participants from 6 years up to 8 years old.

Inclusion Criteria: - must have been in earlier randomized clinical trial Exclusion Criteria:

Additional Information

Official title Intervening Early With Neglected Children: Key Childhood Outcomes
Principal investigator Mary Dozier, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Delaware.