Intervening Early With Neglected Children: Key Childhood Outcomes
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- University of Delaware
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Emotion regulation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •must have been in earlier randomized clinical trial
Exclusion Criteria
- Not provided
Arms & Interventions
Low-risk
Low-risk comparison group
Attachment and Biobehavioral Catch-up
Attachment and Biobehavioral Catch-up - 10 session intervention to enhance nurturance and following the lead
Intervention: Attachment and Biobehavioral Catch-up (Behavioral)
Developmental Education for Families
Developmental Education for Families - 10 session intervention that targets cognitive development
Intervention: Developmental Education for Families (Behavioral)
Outcomes
Primary Outcomes
Emotion regulation
Time Frame: Child age of 36 months
Children will complete emotion regulation tasks (Perfect Circle and Disappointing Gift)
Cortisol production
Time Frame: Child age of 10
Salivary cortisol levels collected at wake-up and bedtime
Attachment
Time Frame: Age 18 months
Attachment assessed through Strange Situation
Child diagnosis
Time Frame: Child age of 10
Parents will complete diagnostic interview.
Inhibitory control
Time Frame: Child age of 36 months
DB-DOS- children who successfully do not touch forbidden toys
Peer relations
Time Frame: Child age of 10 years
Social information processing will be assessed through children's responses to videos of peer provocations.
Child aggression
Time Frame: Child age of 10
Children will complete video game that will allow assessment of reactive and proactive aggression.
Secondary Outcomes
- Parent Attachment Script Knowledge(Child age of 9)
- Child inhibitory control in middle childhood(Child age 8)
- Child attachment security (self-reported on Kerns' Attachment Inventory)(Child age 10)
- Parental sensitivity(Child age of infancy (12-24 months child age))
- Parent neural activity assessed through event related potentials(Child age 4)
- Child attachment security (narrative measure)(Child age 9)
- Autonomic nervous system activity(Child age 10)
- Child brain activity(Child age 9)
- Alpha and theta wave(Child age 9)
- Round Robin Assessment of Peer Rejection(Child age 9)
- Parental sensitivity using Parent-Child Interaction Coding System(Child age 9)
- Body mass index(Age 4)
Investigators
Mary Dozier
Principal Investigator
University of Delaware