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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

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02667522 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Parenting quality [ Time Frame: On average, 1 month after intervention ]
    Observational assessments of positive and harsh parenting
  • Child anxiety symptoms [ Time Frame: On average, 1 month after intervention ]
    Parent Questionnaire
  • Child depressive symptoms [ Time Frame: On average, 1 month after intervention ]
    Parent Questionnaire
  • Child anxiety [ Time Frame: On average, 1 month after intervention ]
    Structured diagnostic interview
  • Child depression [ Time Frame: On average, 1 month after intervention ]
    Structured diagnostic interview
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shaping Neural Activity Through Parenting
Official Title  ICMJE Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Anxiety
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Parenting Intervention
    Parenting Intervention: Parent-Child Interaction Therapy (PCIT)
    Intervention: Behavioral: Parent Child Interaction Therapy (PCIT)
  • No Intervention: Waitlist Control
    Waitlist Control Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2016)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kristin Bernard 6316327576 kristin.bernard@stonybrook.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02667522
Other Study ID Numbers  ICMJE R21MH108766-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kristin Bernard, Stony Brook University
Study Sponsor  ICMJE Stony Brook University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristin Bernard Stony Brook University
PRS Account Stony Brook University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP