A Phase 1/2 interventional study of Attachment and Biobehavioral Catch-up and Developmental Education for Families in Conduct Disorder, ADHD and Depression, sponsored by University of Delaware. Status unknown at 1 site in United States. Open to participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2020-11-17.
Sponsored by University of Delaware · Phase 1/2, Interventional, and Prevention
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.
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.
101 studies on the registry are indexed under Conduct Disorder; 15 are open to participants now.
This study's enrollment of 220 is above the median of 124 across 80 interventional studies indexed under Conduct Disorder.
Browse Conduct Disorder studies →University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
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Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead
Behavioral: Attachment and Biobehavioral Catch-up
Developmental Education for Families - 10 session intervention that targets cognitive development
Behavioral: Developmental Education for Families
Low-risk comparison group
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.
Inhibitory control
DB-DOS- children who successfully do not touch forbidden toys
Time frame: Child age of 36 months
Emotion regulation
Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Time frame: Child age of 36 months
Peer relations
Social information processing will be assessed through children's responses to videos of peer provocations.
Time frame: Child age of 10 years
Child diagnosis
Parents will complete diagnostic interview.
Time frame: Child age of 10
Child aggression
Children will complete video game that will allow assessment of reactive and proactive aggression.
Time frame: Child age of 10
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Time frame: Child age of 24 months
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Time frame: Child age of 8
Cortisol production
Salivary cortisol levels collected at wake-up and bedtime
Time frame: Child age of 10
Attachment
Attachment assessed through Strange Situation
Time frame: Age 18 months
Parental sensitivity
Parental sensitivity will be assessed through parent-child interactions.
Time frame: Child age of infancy (12-24 months child age)
Child attachment security (narrative measure)
Children's score on Attachment Script Assessment, a narrative technique
Time frame: Child age 9
Child inhibitory control in middle childhood
Delay task (Flanker). ERP data will be collected.
Time frame: Child age 8
Autonomic nervous system activity
Child heart rate and respiratory sinus arrhythmia
Time frame: Child age 8
Child brain activity
Child brain activation assessed in fMRI
Time frame: Child age 9
Parent Attachment Script Knowledge
Parents' score on Attachment Script Assessment, a narrative technique
Time frame: 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)
Time frame: Child age 9
Autonomic nervous system activity
Child Respiratory Sinus Arrhythmia (RSA)
Time frame: Child age 10
Alpha and theta wave
Alpha and theta wave activity in resting state EEG
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Child age 10
Body mass index
Proportion of height to weight
Time frame: Age 3
Body mass index
Proportion of height to weight
Time frame: Age 4
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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