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Intervening Early With Neglected Children

Primary Purpose

Conduct Disorder, ADHD, Depression

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Attachment and Biobehavioral Catch-up
Developmental Education for Families
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Conduct Disorder focused on measuring Parenting, Parent child relations, Middle childhood outcomes

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • must have been in earlier randomized clinical trial

Exclusion Criteria:

-

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Attachment and Biobehavioral Catch-up

Developmental Education for Families

Low-risk

Arm Description

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

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

Low-risk comparison group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Parental sensitivity
Parental sensitivity will be assessed through parent-child interactions.
Child attachment security (narrative measure)
Children's score on Attachment Script Assessment, a narrative technique
Child inhibitory control in middle childhood
Delay task (Flanker). ERP data will be collected.
Autonomic nervous system activity
Child heart rate and respiratory sinus arrhythmia
Child brain activity
Child brain activation assessed in fMRI
Parent Attachment Script Knowledge
Parents' score on Attachment Script Assessment, a narrative technique
Parental sensitivity using Parent-Child Interaction Coding System
Extent to which parent is responsive and attuned in support discussion (coded behaviorally)
Autonomic nervous system activity
Child Respiratory Sinus Arrhythmia (RSA)
Alpha and theta wave
Alpha and theta wave activity in resting state EEG
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
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
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 attachment security (self-reported on Kerns' Attachment Inventory)
Self-report from child of extent to which he or she can rely on parent
Child attachment security (self-reported on Kerns' Attachment Inventory)
Self-report from child of extent to which he or she can rely on parent
Body mass index
Proportion of height to weight
Body mass index
Proportion of height to weight

Full Information

First Posted
March 18, 2014
Last Updated
November 14, 2020
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT02093052
Brief Title
Intervening Early With Neglected Children
Official Title
Intervening Early With Neglected Children: Key Childhood Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conduct Disorder, ADHD, Depression
Keywords
Parenting, Parent child relations, Middle childhood outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attachment and Biobehavioral Catch-up
Arm Type
Experimental
Arm Description
Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead
Arm Title
Developmental Education for Families
Arm Type
Active Comparator
Arm Description
Developmental Education for Families - 10 session intervention that targets cognitive development
Arm Title
Low-risk
Arm Type
No Intervention
Arm Description
Low-risk comparison group
Intervention Type
Behavioral
Intervention Name(s)
Attachment and Biobehavioral Catch-up
Intervention Description
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
Intervention Type
Behavioral
Intervention Name(s)
Developmental Education for Families
Intervention Description
Enhance children's cognitive development. In-home intervention with parents and children present.
Primary Outcome Measure Information:
Title
Inhibitory control
Description
DB-DOS- children who successfully do not touch forbidden toys
Time Frame
Child age of 36 months
Title
Emotion regulation
Description
Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Time Frame
Child age of 36 months
Title
Peer relations
Description
Social information processing will be assessed through children's responses to videos of peer provocations.
Time Frame
Child age of 10 years
Title
Child diagnosis
Description
Parents will complete diagnostic interview.
Time Frame
Child age of 10
Title
Child aggression
Description
Children will complete video game that will allow assessment of reactive and proactive aggression.
Time Frame
Child age of 10
Title
Cortisol production
Description
Salivary cortisol levels collected at wake-up and bedtime
Time Frame
Child age of 24 months
Title
Cortisol production
Description
Salivary cortisol levels collected at wake-up and bedtime
Time Frame
Child age of 8
Title
Cortisol production
Description
Salivary cortisol levels collected at wake-up and bedtime
Time Frame
Child age of 10
Title
Attachment
Description
Attachment assessed through Strange Situation
Time Frame
Age 18 months
Secondary Outcome Measure Information:
Title
Parental sensitivity
Description
Parental sensitivity will be assessed through parent-child interactions.
Time Frame
Child age of infancy (12-24 months child age)
Title
Child attachment security (narrative measure)
Description
Children's score on Attachment Script Assessment, a narrative technique
Time Frame
Child age 9
Title
Child inhibitory control in middle childhood
Description
Delay task (Flanker). ERP data will be collected.
Time Frame
Child age 8
Title
Autonomic nervous system activity
Description
Child heart rate and respiratory sinus arrhythmia
Time Frame
Child age 8
Title
Child brain activity
Description
Child brain activation assessed in fMRI
Time Frame
Child age 9
Title
Parent Attachment Script Knowledge
Description
Parents' score on Attachment Script Assessment, a narrative technique
Time Frame
Child age of 9
Title
Parental sensitivity using Parent-Child Interaction Coding System
Description
Extent to which parent is responsive and attuned in support discussion (coded behaviorally)
Time Frame
Child age 9
Title
Autonomic nervous system activity
Description
Child Respiratory Sinus Arrhythmia (RSA)
Time Frame
Child age 10
Title
Alpha and theta wave
Description
Alpha and theta wave activity in resting state EEG
Time Frame
Child age 9
Title
Round Robin Assessment of Peer Rejection
Description
Play groups of unknown peers constituted and video recorded; videos coded at microanalytic level for indices of peer rejection
Time Frame
Child age 9
Title
Parent neural activity assessed through event related potentials
Description
Negative 170 ms. (N170: negative deflection 170 ms. after onset of stimulus) in task discriminating infant affect
Time Frame
Child age 4
Title
Parent neural activity assessed through event related potentials
Description
Late positive potential - 350-600 ms after onset of stimulus (LPP) in task discriminating infant affect
Time Frame
Child age 4
Title
Child attachment security (self-reported on Kerns' Attachment Inventory)
Description
Self-report from child of extent to which he or she can rely on parent
Time Frame
Child age 9
Title
Child attachment security (self-reported on Kerns' Attachment Inventory)
Description
Self-report from child of extent to which he or she can rely on parent
Time Frame
Child age 10
Title
Body mass index
Description
Proportion of height to weight
Time Frame
Age 3
Title
Body mass index
Description
Proportion of height to weight
Time Frame
Age 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have been in earlier randomized clinical trial Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Dozier, Ph.D.
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32781397
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.
Results Reference
derived
PubMed Identifier
32731812
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.
Results Reference
derived
PubMed Identifier
31677152
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.
Results Reference
derived
PubMed Identifier
30659782
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.
Results Reference
derived
PubMed Identifier
25436448
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.
Results Reference
derived

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Intervening Early With Neglected Children

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