Shaping Neural Activity Through Parenting

NCT ID: NCT02667522

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-01-31

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Parenting Intervention

Parenting Intervention: Parent-Child Interaction Therapy (PCIT)

Group Type: EXPERIMENTAL

Parent Child Interaction Therapy (PCIT)

Intervention Type: BEHAVIORAL

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.

Waitlist Control

Waitlist Control Condition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Kristin Bernard

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Bernard

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University

Stony Brook, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin Bernard

Role: CONTACT

kristin.bernard@stonybrook.edu

6316327576

Facility Contacts

Aline Szenczy, BS

Role: primary

Other Identifiers

R21MH108766-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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