Clinical trial NCT02093052: Intervening Early With Neglected Children
Official title: Intervening Early With Neglected Children: Key Childhood Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Conduct Disorder
ADHD
Depression
Keywords: Parenting
Parent child relations
Middle childhood outcomes
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* must have been in earlier randomized clinical trial

Exclusion Criteria:

-

Primary outcomes:
measure: Inhibitory control
timeFrame: Child age of 36 months
measure: Emotion regulation
timeFrame: Child age of 36 months
measure: Peer relations
timeFrame: Child age of 10 years
measure: Child diagnosis
timeFrame: Child age of 10
measure: Child aggression
timeFrame: Child age of 10
measure: Cortisol production
timeFrame: Child age of 24 months
measure: Cortisol production
timeFrame: Child age of 8
measure: Cortisol production
timeFrame: Child age of 10
measure: Attachment
timeFrame: Age 18 months
Secondary outcomes:
measure: Parental sensitivity
timeFrame: Child age of infancy (12-24 months child age)
measure: Child attachment security (narrative measure)
timeFrame: Child age 9
measure: Child inhibitory control in middle childhood
timeFrame: Child age 8
measure: Autonomic nervous system activity
timeFrame: Child age 8
measure: Child brain activity
timeFrame: Child age 9
measure: Parent Attachment Script Knowledge
timeFrame: Child age of 9
measure: Parental sensitivity using Parent-Child Interaction Coding System
timeFrame: Child age 9
measure: Autonomic nervous system activity
timeFrame: Child age 10
measure: Alpha and theta wave
timeFrame: Child age 9
measure: Round Robin Assessment of Peer Rejection
timeFrame: Child age 9
measure: Parent neural activity assessed through event related potentials
timeFrame: Child age 4
measure: Parent neural activity assessed through event related potentials
timeFrame: Child age 4
measure: Child attachment security (self-reported on Kerns' Attachment Inventory)
timeFrame: Child age 9
measure: Child attachment security (self-reported on Kerns' Attachment Inventory)
timeFrame: Child age 10
measure: Body mass index
timeFrame: Age 3
measure: Body mass index
timeFrame: Age 4
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garnett M, Bernard K, Hoye J, Zajac L, Dozier M. Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial. Psychoneuroendocrinology. 2020 Nov;121:104809. doi: 10.1016/j.psyneuen.2020.104809. Epub 2020 Jul 24.
citation: Valadez EA, Tottenham N, Tabachnick AR, Dozier M. Early Parenting Intervention Effects on Brain Responses to Maternal Cues Among High-Risk Children. Am J Psychiatry. 2020 Sep 1;177(9):818-826. doi: 10.1176/appi.ajp.2020.20010011. Epub 2020 Jul 31.
citation: Zajac L, Raby KL, Dozier M. Sustained effects on attachment security in middle childhood: results from a randomized clinical trial of the Attachment and Biobehavioral Catch-up (ABC) intervention. J Child Psychol Psychiatry. 2020 Apr;61(4):417-424. doi: 10.1111/jcpp.13146. Epub 2019 Nov 1.
citation: Bernard K, Frost A, Jelinek C, Dozier M. Secure attachment predicts lower body mass index in young children with histories of child protective services involvement. Pediatr Obes. 2019 Jul;14(7):e12510. doi: 10.1111/ijpo.12510. Epub 2019 Jan 18.
citation: Bernard K, Hostinar CE, Dozier M. Intervention effects on diurnal cortisol rhythms of Child Protective Services-referred infants in early childhood: preschool follow-up results of a randomized clinical trial. JAMA Pediatr. 2015 Feb;169(2):112-9. doi: 10.1001/jamapediatrics.2014.2369.