Intervening Early: Key Adolescent Outcomes

NCT04168684 | Completed

• 2 other identifiers: NIMH074374adolR01MH074374
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depressive Symptoms; Conduct Disorder; Anxiety Disorders

Outcome Measures

Primary Outcomes (35)

• Brain activation in Stop Signal Task

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

  Child age 13 years

• Brain activation in Mother-Stranger Task

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

  Age 13 years

• Brain activation in Mother-Stranger Task

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

  Age 15 years

• Brain activation in Emotion Go/Nogo task

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

  Age 13 years

• Brain activation in Emotional Reappraisal Task

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

  Age 14 years

• Brain activation in Emotion Go/Nogo task

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

  Age 15 years

• 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.

  Age 13 years

• 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.

  Age 13 years

• 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.

  Age 13 years

• 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.

  Age 14 years

• 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.

  Age 15 years

• 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.

  Age 13 years

• 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.

  Age 14 years

• 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.

  15 years of age.

• 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.

  13 years of age.

• 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.

  14 years of age.

• 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.

  15 years of age.

• 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.

  13 years of age

• 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).

  13 years of age

• 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).

  15 years of age

• 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.

  13 years of age

• 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.

  14 years of age

• 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.

  15 years of age

• 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.

  13 years of age

• 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.

  14 years of age

• 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.

  15 years of age

• Adolescent substance use

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

  13 years of age

• Adolescent substance use

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

  14 years of age

• Adolescent substance use

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

  15 years of age

• Adolescent risky behaviors

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

  13 years of age

• Adolescent risky behaviors

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

  14 years of age

• Adolescent risky behaviors

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

  15 years of age

• Mini-International Neuropsychiatric Interview for Children and Adolescents

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

  13 years of age

• Mini-International Neuropsychiatric Interview for Children and Adolescents

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

  14 years of age

• Emotional Regulation Questionnaire

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

  14 years of age

Study Arms (2)

Attachment and Biobehavioral Catch-up (ABC)

EXPERIMENTAL

10 sessions that focused on parental nurturance, and sensitivity

Behavioral: Attachment and Biobehavioral Catch-up (ABC)

Developmental Education for Families (DEF)

ACTIVE COMPARATOR

10 sessions that focused on cognitive development

Behavioral: Developmental Education for Families (DEF)

Interventions

Attachment and Biobehavioral Catch-up (ABC) BEHAVIORAL

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

Attachment and Biobehavioral Catch-up (ABC)

Developmental Education for Families (DEF) BEHAVIORAL

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

Developmental Education for Families (DEF)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must have been included in middle childhood data collection

You may not qualify if:

• None

Sponsors & Collaborators

• University of Delaware: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

MeSH Terms

Conditions

Depression; Conduct Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mary Dozier, Ph.D.

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parents received an intervention but did not know whether it was experimental or control. All participants had an identification number that did not indicate group.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Families randomized to Attachment and Biobehavioral Catch-up (ABC) or to a control intervention (DEF)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 19, 2019
• Study Start: August 2, 2019
• Primary Completion: February 28, 2026
• Study Completion: March 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months following final data collection for at least 3 years.

Locations

US (1)