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Shaping Neural Activity Through Parenting (SNAP)

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ClinicalTrials.gov Identifier: NCT02667522
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kristin Bernard, Stony Brook University

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Parent Child Interaction Therapy (PCIT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
Study Start Date : April 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Parenting

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Parenting quality [ Time Frame: On average, 1 month after intervention ]
    Observational assessments of positive and harsh parenting

  2. Child anxiety symptoms [ Time Frame: On average, 1 month after intervention ]
    Parent Questionnaire

  3. Child depressive symptoms [ Time Frame: On average, 1 month after intervention ]
    Parent Questionnaire

  4. Child anxiety [ Time Frame: On average, 1 month after intervention ]
    Structured diagnostic interview

  5. Child depression [ Time Frame: On average, 1 month after intervention ]
    Structured diagnostic interview



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667522


Contacts
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Contact: Kristin Bernard 6316327576 kristin.bernard@stonybrook.edu

Locations
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United States, New York
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Aline Szenczy, BS         
Sponsors and Collaborators
Stony Brook University
Investigators
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Principal Investigator: Kristin Bernard Stony Brook University

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Responsible Party: Kristin Bernard, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT02667522     History of Changes
Other Study ID Numbers: R21MH108766-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders