Intervening Early: Key Adolescent Outcomes (SCOH-A)

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University of Delaware

Status

Invitation-only

Conditions

Depressive Symptoms
Conduct Disorder
Anxiety Disorders

Treatments

Behavioral: Attachment and Biobehavioral Catch-up (ABC)
Behavioral: Developmental Education for Families (DEF)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04168684
NIMH074374adol
R01MH074374 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must have been included in middle childhood data collection

Exclusion criteria

None

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups

Attachment and Biobehavioral Catch-up (ABC)
Experimental group
Description:
10 sessions that focused on parental nurturance, and sensitivity
Treatment:
Behavioral: Attachment and Biobehavioral Catch-up (ABC)
Developmental Education for Families (DEF)
Active Comparator group
Description:
10 sessions that focused on cognitive development
Treatment:
Behavioral: Developmental Education for Families (DEF)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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