Intervening Early With Neglected Children

Intervening Early With Neglected Children: Key Childhood Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; ADHD; Conduct Disorder
• Intervention / Treatment: Behavioral: Attachment and Biobehavioral Catch-up; Behavioral: Developmental Education for Families

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19711
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• must have been in earlier randomized clinical trial

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attachment and Biobehavioral Catch-up; Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead	Behavioral: 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; Developmental Education for Families - 10 session intervention that targets cognitive development	Behavioral: Developmental Education for Families; Enhance children's cognitive development. In-home intervention with parents and children present.
No Intervention: Low-risk; Low-risk comparison group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibitory control	DB-DOS- children who successfully do not touch forbidden toys	Child age of 36 months
Emotion regulation	Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)	Child age of 36 months
Peer relations	Social information processing will be assessed through children's responses to videos of peer provocations.	Child age of 10 years
Child diagnosis	Parents will complete diagnostic interview.	Child age of 10
Child aggression	Children will complete video game that will allow assessment of reactive and proactive aggression.	Child age of 10
Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 24 months
Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 8
Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 10
Attachment	Attachment assessed through Strange Situation	Age 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental sensitivity	Parental sensitivity will be assessed through parent-child interactions.	Child age of infancy (12-24 months child age)
Child attachment security (narrative measure)	Children's score on Attachment Script Assessment, a narrative technique	Child age 9
Child inhibitory control in middle childhood	Delay task (Flanker). ERP data will be collected.	Child age 8
Autonomic nervous system activity	Child heart rate and respiratory sinus arrhythmia	Child age 8
Child brain activity	Child brain activation assessed in fMRI	Child age 9
Parent Attachment Script Knowledge	Parents' score on Attachment Script Assessment, a narrative technique	Child age of 9
Parental sensitivity using Parent-Child Interaction Coding System	Extent to which parent is responsive and attuned in support discussion (coded behaviorally)	Child age 9
Autonomic nervous system activity	Child Respiratory Sinus Arrhythmia (RSA)	Child age 10
Alpha and theta wave	Alpha and theta wave activity in resting state EEG	Child age 9
Round Robin Assessment of Peer Rejection	Play groups of unknown peers constituted and video recorded; videos coded at microanalytic level for indices of peer rejection	Child age 9
Parent neural activity assessed through event related potentials	Negative 170 ms. (N170: negative deflection 170 ms. after onset of stimulus) in task discriminating infant affect	Child age 4
Parent neural activity assessed through event related potentials	Late positive potential - 350-600 ms after onset of stimulus (LPP) in task discriminating infant affect	Child age 4
Child attachment security (self-reported on Kerns' Attachment Inventory)	Self-report from child of extent to which he or she can rely on parent	Child age 9
Child attachment security (self-reported on Kerns' Attachment Inventory)	Self-report from child of extent to which he or she can rely on parent	Child age 10
Body mass index	Proportion of height to weight	Age 3
Body mass index	Proportion of height to weight	Age 4

Collaborators and Investigators

• Sponsor: University of Delaware

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 14, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Parenting; Parent child relations; Middle childhood outcomes
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Conduct Disorder
• Other Study ID Numbers: NIH R01 74374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided