Clinical trial NCT04168684: Intervening Early: Key Adolescent Outcomes
Official title: Intervening Early With Neglected Children: Key Adolescent Outcomes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depressive Symptoms
Conduct Disorder
Anxiety Disorders
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-11-19
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Families randomized to Attachment and Biobehavioral Catch-up (ABC) or to a control intervention (DEF)
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Must have been included in middle childhood data collection

Exclusion Criteria:

* None

Primary outcomes:
measure: Brain activation in Stop Signal Task
timeFrame: Child age 13 years
measure: Brain activation in Mother-Stranger Task
timeFrame: Age 13 years
measure: Brain activation in Mother-Stranger Task
timeFrame: Age 15 years
measure: Brain activation in Emotion Go/Nogo task
timeFrame: Age 13 years
measure: Brain activation in Emotional Reappraisal Task
timeFrame: Age 14 years
measure: Brain activation in Emotion Go/Nogo task
timeFrame: Age 15 years
measure: Trier Social Stress Test- Cortisol
timeFrame: Age 13 years
measure: Trier Social Stress Test-ANS
timeFrame: Age 13 years
measure: Revealed differences task - parent sensitivity.
timeFrame: Age 13 years
measure: Support task- parent sensitivity
timeFrame: Age 14 years
measure: Revealed differences task- parent sensitivity
timeFrame: Age 15 years
measure: Revealed differences task-adolescent competence
timeFrame: Age 13 years
measure: Support task-adolescent competence
timeFrame: Age 14 years
measure: Revealed differences task-adolescent competence
timeFrame: 15 years of age.
measure: Revealed differences task-adolescent ANS
timeFrame: 13 years of age.
measure: Support task-adolescent ANS
timeFrame: 14 years of age.
measure: Revealed differences task-adolescent ANS
timeFrame: 15 years of age.
measure: Balloon Analogue Risk Task (BART)
timeFrame: 13 years of age
measure: Delay Discounting
timeFrame: 13 years of age
measure: Delay Discounting
timeFrame: 15 years of age
measure: Child Depression
timeFrame: 13 years of age
measure: Child Depression
timeFrame: 14 years of age
measure: Child Depression
timeFrame: 15 years of age
measure: Child problem behaviors
timeFrame: 13 years of age
measure: Child problem behaviors
timeFrame: 14 years of age
measure: Child problem behaviors
timeFrame: 15 years of age
measure: Adolescent substance use
timeFrame: 13 years of age
measure: Adolescent substance use
timeFrame: 14 years of age
measure: Adolescent substance use
timeFrame: 15 years of age
measure: Adolescent risky behaviors
timeFrame: 13 years of age
measure: Adolescent risky behaviors
timeFrame: 14 years of age
measure: Adolescent risky behaviors
timeFrame: 15 years of age
measure: Mini-International Neuropsychiatric Interview for Children and Adolescents
timeFrame: 13 years of age
measure: Mini-International Neuropsychiatric Interview for Children and Adolescents
timeFrame: 14 years of age
measure: Emotional Regulation Questionnaire
timeFrame: 14 years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Mary Dozier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: