Intervening Early: Key Adolescent Outcomes

Anxiety Disorders Clinical Trial

— SCOH-A  

Official title:

Intervening Early With Neglected Children: Key Adolescent Outcomes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04168684
• Other study ID #: NIMH074374adol
• Secondary ID: R01MH074374
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: September 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

• Must have been included in middle childhood data collection

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Anxiety Disorders
• Conduct Disorder
• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Attachment and Biobehavioral Catch-up (ABC)
Manualized intervention implemented in home with parent and child present focused on parental responsiveness
• Developmental Education for Families (DEF)
Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Brain activation in Mother-Stranger Task	Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers	Age 13 years
Primary	Brain activation in Mother-Stranger Task	Functional connectivity assessed through fMRI when viewing photos of mothers vs. strangers	Age 15 years
Primary	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
Primary	Brain activation in Emotional Reappraisal Task	Functional connectivity between amygdala and PFC assessed through fMRI in emotional reappraisal task	Age 14 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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