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Intervening Early With Neglected Children

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ClinicalTrials.gov Identifier: NCT02093052
Recruitment Status : Active, not recruiting
First Posted : March 20, 2014
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Mary Dozier, University of Delaware

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.

Condition or disease Intervention/treatment Phase
Conduct Disorder ADHD Depression Behavioral: Attachment and Biobehavioral Catch-up Behavioral: Developmental Education for Families Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervening Early With Neglected Children: Key Childhood Outcomes
Study Start Date : March 2005
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Inhibitory control [ Time Frame: Child age of 36 months ]
    DB-DOS- children who successfully do not touch forbidden toys

  2. Emotion regulation [ Time Frame: Child age of 36 months ]
    Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)

  3. Peer relations [ Time Frame: Child age of 10 years ]
    Social information processing will be assessed through children's responses to videos of peer provocations.

  4. Child diagnosis [ Time Frame: Child age of 10 ]
    Parents will complete diagnostic interview.

  5. Child aggression [ Time Frame: Child age of 10 ]
    Children will complete video game that will allow assessment of reactive and proactive aggression.

  6. Cortisol production [ Time Frame: Child age of 24 months ]
    Salivary cortisol levels collected at wake-up and bedtime

  7. Cortisol production [ Time Frame: Child age of 8 ]
    Salivary cortisol levels collected at wake-up and bedtime

  8. Cortisol production [ Time Frame: Child age of 10 ]
    Salivary cortisol levels collected at wake-up and bedtime

  9. Attachment [ Time Frame: Age 18 months ]
    Attachment assessed through Strange Situation


Secondary Outcome Measures :
  1. Parental sensitivity [ Time Frame: Child age of infancy (12-24 months child age) ]
    Parental sensitivity will be assessed through parent-child interactions.

  2. Child attachment security (narrative measure) [ Time Frame: Child age 9 ]
    Children's score on Attachment Script Assessment, a narrative technique

  3. Child inhibitory control in middle childhood [ Time Frame: Child age 8 ]
    Delay task (Flanker). ERP data will be collected.

  4. Autonomic nervous system activity [ Time Frame: Child age 8 ]
    Child heart rate and respiratory sinus arrhythmia

  5. Child brain activity [ Time Frame: Child age 9 ]
    Child brain activation assessed in fMRI

  6. Parent Attachment Script Knowledge [ Time Frame: Child age of 9 ]
    Parents' score on Attachment Script Assessment, a narrative technique

  7. Parental sensitivity using Parent-Child Interaction Coding System [ Time Frame: Child age 9 ]
    Extent to which parent is responsive and attuned in support discussion (coded behaviorally)

  8. Autonomic nervous system activity [ Time Frame: Child age 10 ]
    Child Respiratory Sinus Arrhythmia (RSA)

  9. Alpha and theta wave [ Time Frame: Child age 9 ]
    Alpha and theta wave activity in resting state EEG

  10. Round Robin Assessment of Peer Rejection [ Time Frame: Child age 9 ]
    Play groups of unknown peers constituted and video recorded; videos coded at microanalytic level for indices of peer rejection

  11. Parent neural activity assessed through event related potentials [ Time Frame: Child age 4 ]
    Negative 170 ms. (N170: negative deflection 170 ms. after onset of stimulus) in task discriminating infant affect

  12. Parent neural activity assessed through event related potentials [ Time Frame: Child age 4 ]
    Late positive potential - 350-600 ms after onset of stimulus (LPP) in task discriminating infant affect

  13. Child attachment security (self-reported on Kerns' Attachment Inventory) [ Time Frame: Child age 9 ]
    Self-report from child of extent to which he or she can rely on parent

  14. Child attachment security (self-reported on Kerns' Attachment Inventory) [ Time Frame: Child age 10 ]
    Self-report from child of extent to which he or she can rely on parent

  15. Body mass index [ Time Frame: Age 3 ]
    Proportion of height to weight

  16. Body mass index [ Time Frame: Age 4 ]
    Proportion of height to weight



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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must have been in earlier randomized clinical trial

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093052


Locations
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United States, Delaware
University of Delaware
Newark, Delaware, United States, 19711
Sponsors and Collaborators
University of Delaware
Investigators
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Principal Investigator: Mary Dozier, Ph.D. University of Delaware
  Study Documents (Full-Text)

Documents provided by Mary Dozier, University of Delaware:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mary Dozier, Principal Investigator, University of Delaware
ClinicalTrials.gov Identifier: NCT02093052    
Other Study ID Numbers: NIH R01 74374
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mary Dozier, University of Delaware:
Parenting
Parent child relations
Middle childhood outcomes
Additional relevant MeSH terms:
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Conduct Disorder
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders