Intervening Early: Key Adolescent Outcomes

NCT ID: NCT04168684

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-02
• Study Completion Date: 2025-03-31

Brief Summary

This study follows children into adolescence who were first randomized to intervention condition in infancy.

Detailed Description

Parents serve as co-regulators for their young children, helping them regulate behaviors, emotions, and physiology and supporting the development of healthy brain circuitry. Neglecting parents often fail to serve as co-regulators, which has implications for young children's self-regulatory capabilities and brain development. As children become older, these difficulties with self-regulation may become more pronounced. Adolescence represents a period of particular vulnerability for the emergence of mental health problems because of increasing demands for regulation of emotions and behaviors, coupled with on-going development of neural circuits that support emotional and behavioral regulation. The Attachment and Biobehavioral Catch-up (ABC) intervention was designed to help parents learn to interact in responsive and sensitive ways, with the expectation that children would show enhanced ability to regulate behavior, emotions, and physiology. The efficacy of the ABC intervention among parents involved with Child Protective Services (CPS) was assessed. Parents were randomized to ABC or to a control intervention. Children were followed at T1 (ages 1-4) and T2 (ages 8-10). At T1, more of the children in the ABC group developed secure and organized attachments than children in the DEF group, and children in ABC showed more normative production of cortisol, less expression of negative emotions, and poorer inhibitory control than children in DEF. ABC parents were more sensitive and showed more optimal neural activity than DEF parents. At T2, ABC children showed greater prefrontal cortex activation in response to threat than DEF children, suggesting better regulation to threat at the level of brain activation. Also at T2, children in the ABC group reported more secure relationships with parents, and showed more normative cortisol production and more optimal autonomic nervous system functioning than DEF children. In adolescence, the ABC intervention is expected to result in enhanced brain circuitry and more optimal functioning across domains as assessed at multiple levels of analysis relative to the control intervention. In the proposed study, behavioral and neurobiological development among 13-, 14- and 15-year-old adolescents whose parents were referred by CPS to a randomized controlled trial in infancy (n=120), and among low-risk adolescents followed since middle childhood (n=80) will be assessed.

Conditions

Depressive Symptoms; Conduct Disorder; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Attachment and Biobehavioral Catch-up (ABC)

10 sessions that focused on parental nurturance, and sensitivity

Group Type: EXPERIMENTAL

Attachment and Biobehavioral Catch-up (ABC)

Intervention Type: BEHAVIORAL

Manualized intervention implemented in home with parent and child present focused on parental responsiveness

Developmental Education for Families (DEF)

10 sessions that focused on cognitive development

Group Type: ACTIVE_COMPARATOR

Developmental Education for Families (DEF)

Intervention Type: BEHAVIORAL

Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning

Interventions

Attachment and Biobehavioral Catch-up (ABC)

Manualized intervention implemented in home with parent and child present focused on parental responsiveness

Intervention Type: BEHAVIORAL

Developmental Education for Families (DEF)

Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Must have been included in middle childhood data collection

Exclusion Criteria

• None

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Dozier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

R01MH074374

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIMH074374adol

Identifier Type: -

Identifier Source: org_study_id