Intervening Early With Neglected Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervening Early With Neglected Children: Key Childhood Outcomes

Conditions
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Conduct Disorder, ADHD, Depression

Intervention / Treatment
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* Behavioral: Attachment and Biobehavioral Catch-up
* Behavioral: Developmental Education for Families


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must have been in earlier randomized clinical trial Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenting, Parent child relations, Middle childhood outcomes