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Intervening Early With Neglected Children

Intervening Early With Neglected Children: Key Childhood Outcomes

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02093052
Enrollment
220
Registered
2014-03-20
Start date
2005-03-31
Completion date
2024-04-30
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Conduct Disorder, Depression

Keywords

Parenting, Parent child relations, Middle childhood outcomes

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.

Interventions

Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.

Enhance children's cognitive development. In-home intervention with parents and children present.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* must have been in earlier randomized clinical trial

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Child aggressionChild age of 10Children will complete video game that will allow assessment of reactive and proactive aggression.
Cortisol productionChild age of 24 monthsSalivary cortisol levels collected at wake-up and bedtime
AttachmentAge 18 monthsAttachment assessed through Strange Situation
Inhibitory controlChild age of 36 monthsDB-DOS- children who successfully do not touch forbidden toys
Emotion regulationChild age of 36 monthsChildren will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Peer relationsChild age of 10 yearsSocial information processing will be assessed through children's responses to videos of peer provocations.
Child diagnosisChild age of 10Parents will complete diagnostic interview.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026