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Clinical Trials/NCT02667522
NCT02667522UnknownNot Applicable

Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention

Stony Brook University1 site in 1 country160 target enrollmentStarted: April 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
160
Locations
1
Primary Endpoint
Event-Related Potentials (ERP)

Study Overview

Brief Summary

The purpose of this study is to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors, using a parenting intervention.

Detailed Description

Depression and anxiety are among the most frequently diagnosed psychological disorders, with persistent patterns of impairment evident from childhood through adulthood. Impaired functioning of core brain systems that respond to reward and errors may increase risk for depression and anxiety. Importantly, these neural risk markers for depression and anxiety appear to be shaped, at least in part, by environmental input. Problematic parenting is a key environmental factor involved in the intergenerational transmission of depression and anxiety. Low positive parenting is associated with blunted brain responses to reward and harsh parenting is associated with heightened brain responses to errors. This study uses an evidence-based parenting program to test causal links between dimensions of positive and harsh parenting and children's brain responses to rewards and errors. Participants will include 80 6- to 7-year-old children and their mothers who will be randomly assigned to participate in a parenting program (Parent Child Interaction Therapy: PCIT) or to a waitlist control group, and brain responses to rewards and errors will be assessed pre- and post-intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
6 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Child is 6-7 years old
  • •Maternal history of anxiety or depression
  • •Maternal self-report of low positive/high harsh parenting

Exclusion Criteria

  • •Child has developmental disorder

Arms & Interventions

Parenting Intervention

Experimental

Parenting Intervention: Parent-Child Interaction Therapy (PCIT)

Intervention: Parent Child Interaction Therapy (PCIT) (Behavioral)

Waitlist Control

No Intervention

Waitlist Control Condition

Outcomes

Primary Outcomes

Event-Related Potentials (ERP)

Time Frame: On average, 1 month after intervention

ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)

Secondary Outcomes

  • Parenting quality(On average, 1 month after intervention)
  • Child anxiety symptoms(On average, 1 month after intervention)
  • Child depressive symptoms(On average, 1 month after intervention)
  • Child anxiety(On average, 1 month after intervention)
  • Child depression(On average, 1 month after intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kristin Bernard

Assistant Professor

Stony Brook University

Study Sites (1)

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