Shaping Neural Activity Through Parenting

Depression Clinical Trial

— SNAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02667522
• Other study ID #: R21MH108766-01A1
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2016
• Last updated: April 16, 2018
• Start date: April 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2018
• Source: Stony Brook University
• Contact: Kristin Bernard
• Phone: 6316327576
• Email: kristin.bernard[@]stonybrook.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-Related Potentials (ERP)	ERP responses to reward (i.e., feedback negativity) and errors (i.e., error-related negativity)	On average, 1 month after intervention
Secondary	Parenting quality	Observational assessments of positive and harsh parenting	On average, 1 month after intervention
Secondary	Child anxiety symptoms	Parent Questionnaire	On average, 1 month after intervention
Secondary	Child depressive symptoms	Parent Questionnaire	On average, 1 month after intervention
Secondary	Child anxiety	Structured diagnostic interview	On average, 1 month after intervention
Secondary	Child depression	Structured diagnostic interview	On average, 1 month after intervention