ClinicalTrials.gg
CompletedNCT04168684SCOH-AUpdated May 5, 2026

Intervening Early: Key Adolescent Outcomes

An interventional study of Attachment and Biobehavioral Catch-up (ABC) and Developmental Education for Families (DEF) in Depressive Symptoms, Conduct Disorder and Anxiety Disorders, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Delaware · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Depressive Symptoms
  • Conduct Disorder
  • Anxiety Disorders
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's enrollment of 128 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must have been included in middle childhood data collection

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Attachment and Biobehavioral Catch-up (ABC)

    10 sessions that focused on parental nurturance, and sensitivity

    Behavioral: Attachment and Biobehavioral Catch-up (ABC)

  • Active comparator
    Developmental Education for Families (DEF)

    10 sessions that focused on cognitive development

    Behavioral: Developmental Education for Families (DEF)

Interventions

  • BehavioralAttachment and Biobehavioral Catch-up (ABC)

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

  • BehavioralDevelopmental Education for Families (DEF)

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

06

What researchers measure

Primary outcomes

  1. Brain activation in Stop Signal Task

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

    Time frame: Child age 13 years

  2. Brain activation in Mother-Stranger Task

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

    Time frame: Age 13 years

  3. Brain activation in Mother-Stranger Task

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

    Time frame: Age 15 years

  4. Brain activation in Emotion Go/Nogo task

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

    Time frame: Age 13 years

  5. Brain activation in Emotional Reappraisal Task

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

    Time frame: Age 14 years

  6. Brain activation in Emotion Go/Nogo task

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

    Time frame: Age 15 years

  7. Trier Social Stress Test- Cortisol

    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.

    Time frame: Age 13 years

  8. Trier Social Stress Test-ANS

    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.

    Time frame: Age 13 years

  9. Revealed differences task - parent sensitivity.

    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.

    Time frame: Age 13 years

  10. Support task- parent sensitivity

    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.

    Time frame: Age 14 years

  11. Revealed differences task- parent sensitivity

    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.

    Time frame: Age 15 years

  12. Revealed differences task-adolescent competence

    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.

    Time frame: Age 13 years

  13. Support task-adolescent competence

    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.

    Time frame: Age 14 years

  14. Revealed differences task-adolescent competence

    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.

    Time frame: 15 years of age.

  15. Revealed differences task-adolescent ANS

    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.

    Time frame: 13 years of age.

  16. Support task-adolescent ANS

    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.

    Time frame: 14 years of age.

  17. Revealed differences task-adolescent ANS

    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.

    Time frame: 15 years of age.

  18. Balloon Analogue Risk Task (BART)

    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.

    Time frame: 13 years of age

  19. Delay Discounting

    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).

    Time frame: 13 years of age

  20. Delay Discounting

    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).

    Time frame: 15 years of age

  21. Child Depression

    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.

    Time frame: 13 years of age

  22. Child Depression

    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.

    Time frame: 14 years of age

  23. Child Depression

    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.

    Time frame: 15 years of age

  24. Child problem behaviors

    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.

    Time frame: 13 years of age

  25. Child problem behaviors

    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.

    Time frame: 14 years of age

  26. Child problem behaviors

    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.

    Time frame: 15 years of age

  27. Adolescent substance use

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

    Time frame: 13 years of age

  28. Adolescent substance use

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

    Time frame: 14 years of age

  29. Adolescent substance use

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

    Time frame: 15 years of age

  30. Adolescent risky behaviors

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

    Time frame: 13 years of age

  31. Adolescent risky behaviors

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

    Time frame: 14 years of age

  32. Adolescent risky behaviors

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

    Time frame: 15 years of age

  33. Mini-International Neuropsychiatric Interview for Children and Adolescents

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

    Time frame: 13 years of age

  34. Mini-International Neuropsychiatric Interview for Children and Adolescents

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

    Time frame: 14 years of age

  35. Emotional Regulation Questionnaire

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

    Time frame: 14 years of age

07

Study locations

1 site
  • University of Delaware
    Newark, Delaware 19716, United States
08

References and documents

Individual participant data

Plan to share: Yes — As described below, data will be made available to the scientific community for further analysis and novel research purposes after the primary results of the study have been published. De-identified research data will be shared in spreadsheet format for all clinical assessment, survey, and behavioral data. MRI data will be shared in NIFTI format. A description of the variables that are included in the dataset as well as a description of the data collection methods will also be provided. All data sharing will be done in consultation with our IRB. Results will be shared within one year of the completion of data collection of primary outcome measures.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 12 months following final data collection for at least 3 years.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04168684
Responsible party
Sponsor
First posted
Nov 19, 2019
Start date
Aug 2, 2019
Primary completion
Feb 28, 2026
Completion
Mar 31, 2026
Last update
May 5, 2026

Study contacts

Mary Dozier, Ph.D.
principal investigator · University of Delaware

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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