Shaping Neural Activity Through Parenting (SNAP)

April 16, 2018 updated by: Kristin Bernard, Stony Brook University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University
        • Contact:
          • Aline Szenczy, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parenting Intervention
Parenting Intervention: Parent-Child Interaction Therapy (PCIT)
Behavioral: Parent Child Interaction Therapy (PCIT)
PCIT includes 12-16 sessions across two phases: the first focused on enhancing positive parenting during child-directed interactions, and the second focused on reducing harsh parenting during parent-directed interactions. Parents receive feedback and coaching on their interactions with the child during sessions.
No Intervention: Waitlist Control
Waitlist Control Condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On average, 1 month after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting quality
Time Frame: On average, 1 month after intervention
Observational assessments of positive and harsh parenting
On average, 1 month after intervention
Child anxiety symptoms
Time Frame: On average, 1 month after intervention
Parent Questionnaire
On average, 1 month after intervention
Child depressive symptoms
Time Frame: On average, 1 month after intervention
Parent Questionnaire
On average, 1 month after intervention
Child anxiety
Time Frame: On average, 1 month after intervention
Structured diagnostic interview
On average, 1 month after intervention
Child depression
Time Frame: On average, 1 month after intervention
Structured diagnostic interview
On average, 1 month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Investigators

  • Principal Investigator: Kristin Bernard, Stony Brook University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH108766-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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