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Completed

NCT Number: NCT04168684

Intervening Early: Key Adolescent Outcomes

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

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Key information

Conditions

Depressive Symptoms Anxiety Disorders Attention Deficit and Disruptive Behavior Disorders Behavior Behavioral Symptoms Conduct Disorder Depression Mental Disorders Neurodevelopmental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19716, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have been included in middle childhood data collection

Exclusion criteria

  • None

Treatment and study plan

Attachment and Biobehavioral Catch-up (ABC)

Behavioral

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

Developmental Education for Families (DEF)

Behavioral

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

Primary outcomes

  1. Brain activation in Stop Signal Task

    Time frame: Child age 13 years

    Prefrontal cortex activation assessed through functional magnetic resonance imaging (fMRI) in task requiring inhibitory control

  2. Brain activation in Mother-Stranger Task

    Time frame: Age 13 years

    Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers

  3. Brain activation in Mother-Stranger Task

    Time frame: Age 15 years

    Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers

  4. Brain activation in Emotion Go/Nogo task

    Time frame: Age 13 years

    Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task

  5. Brain activation in Emotional Reappraisal Task

    Time frame: Age 14 years

    Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task

  6. Brain activation in Emotion Go/Nogo task

    Time frame: Age 15 years

    Functional connectivity between amygdala and PFC assessed through fMRI in an emotion go/no go task

  7. Trier Social Stress Test- Cortisol

    Time frame: Age 13 years

    Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997). For the purpose of assessing cortisol, investigators will collect saliva samples before and after the speech/math.

  8. Trier Social Stress Test-ANS

    Time frame: Age 13 years

    Participants will be met by two research assistants (one male, one female), whom they have not met previously. The research assistants will tell the participants that they will have 5 minutes to prepare a speech which they will give to the researchers who will rate the speech. Participants will then give their speeches for 5 minutes; the research assistants will maintain neutral expressions and provide no feedback. Afterwards, participants will be asked to do (age-adjusted) mental arithmetic aloud (Buske-Kirschbaum et al.,1997).Assess child autonomic nervous system regulation, examine reactivity from baseline in RSA.

  9. Revealed differences task - parent sensitivity.

    Time frame: Age 13 years

    Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.

  10. Support task- parent sensitivity

    Time frame: Age 14 years

    Parents and children engage in support discussion (discussing Trier task from previous year). Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.

  11. Revealed differences task- parent sensitivity

    Time frame: Age 15 years

    Parents and children engage in conflict discussion. Assess parental sensitivity using Sensitivity scale. Parental behavior is scored on a 1-7 scale, with higher scores reflecting greater sensitivity.

  12. Revealed differences task-adolescent competence

    Time frame: Age 13 years

    Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.

  13. Support task-adolescent competence

    Time frame: Age 14 years

    Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.

  14. Revealed differences task-adolescent competence

    Time frame: 15 years of age.

    Parents and children engage in conflict discussion. Assess child competence in discussion on Competence scale. Competence is scored on a 1-7 scale, with higher scores reflecting greater competence.

  15. Revealed differences task-adolescent ANS

    Time frame: 13 years of age.

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.

    Parents and children engage in conflict discussion. Assess child autonomic nervous system regulation. Respiratory sinus arrhythmia (RSA) will be measured as a rise from baseline.

  16. Support task-adolescent ANS

    Time frame: 14 years of age.

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.

  17. Revealed differences task-adolescent ANS

    Time frame: 15 years of age.

    The control of cardiac functions via the vagal nerve, or vagal tone, is an index of parasympathetic activity. It can be measured by heart rate variability associated with respiration or high frequency respiratory sinus arrhythmia (RSA). RSA data will be collected continuously throughout the parent-child interaction using a MindWare Portable Lab system. Greater changes in RSA from baseline to discussion considered preferable.

  18. Balloon Analogue Risk Task (BART)

    Time frame: 13 years of age

    This task assesses risk-taking through a computer game in which participants see a balloon on the computer screen and have the option of pumping up the balloon more, and therefore increasing its monetary value, or stopping and collecting the value of the balloon. If the balloon pops on a pump, then all of the value of the balloon is lost and the next trial begins. There is a randomly, pre-determined probability of the balloon popping on any given pump of each trial. A brief version of the task with 15 balloons will be used. A running tally of participants' total monetary gain is kept (and can range from $0 up to a cap of $5). The amount of money earned is the score, with more money reflecting higher risk taking.

  19. Delay Discounting

    Time frame: 13 years of age

    Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).

  20. Delay Discounting

    Time frame: 15 years of age

    Delay Discounting Task is a brief, five-item task on a computer that asks participants their preference between $5 now and $10 at some later time point (Koffarnus, Warren, & Bickel, 2014). No money is actually earned on this task. A score from 0 to 5 is received with lower score indicating better delay (preferred).

  21. Child Depression

    Time frame: 13 years of age

    Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.

  22. Child Depression

    Time frame: 14 years of age

    Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.

  23. Child Depression

    Time frame: 15 years of age

    Child Depression Inventory-Short Version (CDI-S): A 10-item measure that screens for depression (Kovacs, 2010). Scores can range from 0-24, with higher scores reflecting greater depression.

  24. Child problem behaviors

    Time frame: 13 years of age

    Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.

  25. Child problem behaviors

    Time frame: 14 years of age

    Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.

  26. Child problem behaviors

    Time frame: 15 years of age

    Child Behavior Checklist (CBCL): Parents will complete the 113 items from the CBCL to assess adolescents' internalizing and externalizing symptoms (Achenbach et al., 2001). Raw scores range from 0-240. Higher scores reflect greater problems.

  27. Adolescent substance use

    Time frame: 13 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.

  28. Adolescent substance use

    Time frame: 14 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.

  29. Adolescent substance use

    Time frame: 15 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more substance use, with a possible range of 21-98.

  30. Adolescent risky behaviors

    Time frame: 13 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.

  31. Adolescent risky behaviors

    Time frame: 14 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.

  32. Adolescent risky behaviors

    Time frame: 15 years of age

    Adolescents will complete the Youth Risk Behavior Survey. Higher scores reflect more risky problems, with a possible range of 8-28.

  33. Mini-International Neuropsychiatric Interview for Children and Adolescents

    Time frame: 13 years of age

    Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.

  34. Mini-International Neuropsychiatric Interview for Children and Adolescents

    Time frame: 14 years of age

    Psychiatric interview. Higher scores reflect more psychiatric symptoms, with a range of 0-8.

  35. Emotional Regulation Questionnaire

    Time frame: 14 years of age

    Assesses how effectively adolescents regulate or control emotions. Higher scores reflect better regulation. Scores range from 10-50.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Intervening Early With Neglected Children: Key Adolescent Outcomes

Acronym: SCOH-A

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2019
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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