Shaping Neural Activity Through Parenting (SNAP)
Primary Purpose
Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Child Interaction Therapy (PCIT)
Sponsored by
About this trial
This is an interventional prevention trial for Depression
Eligibility 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
Sites / Locations
- Stony Brook UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parenting Intervention
Waitlist Control
Arm Description
Parenting Intervention: Parent-Child Interaction Therapy (PCIT)
Waitlist Control Condition
Outcomes
Primary Outcome Measures
Event-Related Potentials (ERP)
ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)
Secondary Outcome Measures
Parenting quality
Observational assessments of positive and harsh parenting
Child anxiety symptoms
Parent Questionnaire
Child depressive symptoms
Parent Questionnaire
Child anxiety
Structured diagnostic interview
Child depression
Structured diagnostic interview
Full Information
NCT ID
NCT02667522
First Posted
January 11, 2016
Last Updated
April 16, 2018
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT02667522
Brief Title
Shaping Neural Activity Through Parenting
Acronym
SNAP
Official Title
Targeting Biomarkers of Risk for Depression and Anxiety Through a Parenting Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Parenting Intervention
Arm Type
Experimental
Arm Description
Parenting Intervention: Parent-Child Interaction Therapy (PCIT)
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Waitlist Control Condition
Intervention Type
Behavioral
Intervention Name(s)
Parent Child Interaction Therapy (PCIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Event-Related Potentials (ERP)
Description
ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)
Time Frame
On average, 1 month after intervention
Secondary Outcome Measure Information:
Title
Parenting quality
Description
Observational assessments of positive and harsh parenting
Time Frame
On average, 1 month after intervention
Title
Child anxiety symptoms
Description
Parent Questionnaire
Time Frame
On average, 1 month after intervention
Title
Child depressive symptoms
Description
Parent Questionnaire
Time Frame
On average, 1 month after intervention
Title
Child anxiety
Description
Structured diagnostic interview
Time Frame
On average, 1 month after intervention
Title
Child depression
Description
Structured diagnostic interview
Time Frame
On average, 1 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Bernard
Phone
6316327576
Email
kristin.bernard@stonybrook.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Bernard
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline Szenczy, BS
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Shaping Neural Activity Through Parenting
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