Intervening Early With Neglected Children

Depression Clinical Trial

Official title:

Intervening Early With Neglected Children: Key Childhood Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02093052
• Other study ID #: NIH R01 74374
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 2005
• Est. completion date: April 2024

Study information

• Verified date: November 2020
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• must have been in earlier randomized clinical trial

Exclusion Criteria:

-

Related Conditions & MeSH terms

• ADHD
• Conduct Disorder
• Depression

Intervention

Behavioral:
• Attachment and Biobehavioral Catch-up
Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
• Developmental Education for Families
Enhance children's cognitive development. In-home intervention with parents and children present.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inhibitory control	DB-DOS- children who successfully do not touch forbidden toys	Child age of 36 months
Primary	Emotion regulation	Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)	Child age of 36 months
Primary	Peer relations	Social information processing will be assessed through children's responses to videos of peer provocations.	Child age of 10 years
Primary	Child diagnosis	Parents will complete diagnostic interview.	Child age of 10
Primary	Child aggression	Children will complete video game that will allow assessment of reactive and proactive aggression.	Child age of 10
Primary	Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 24 months
Primary	Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 8
Primary	Cortisol production	Salivary cortisol levels collected at wake-up and bedtime	Child age of 10
Primary	Attachment	Attachment assessed through Strange Situation	Age 18 months
Secondary	Parental sensitivity	Parental sensitivity will be assessed through parent-child interactions.	Child age of infancy (12-24 months child age)
Secondary	Child attachment security (narrative measure)	Children's score on Attachment Script Assessment, a narrative technique	Child age 9
Secondary	Child inhibitory control in middle childhood	Delay task (Flanker). ERP data will be collected.	Child age 8
Secondary	Autonomic nervous system activity	Child heart rate and respiratory sinus arrhythmia	Child age 8
Secondary	Child brain activity	Child brain activation assessed in fMRI	Child age 9
Secondary	Parent Attachment Script Knowledge	Parents' score on Attachment Script Assessment, a narrative technique	Child age of 9
Secondary	Parental sensitivity using Parent-Child Interaction Coding System	Extent to which parent is responsive and attuned in support discussion (coded behaviorally)	Child age 9
Secondary	Autonomic nervous system activity	Child Respiratory Sinus Arrhythmia (RSA)	Child age 10
Secondary	Alpha and theta wave	Alpha and theta wave activity in resting state EEG	Child age 9
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Body mass index	Proportion of height to weight	Age 3
Secondary	Body mass index	Proportion of height to weight	Age 4