NCT02667522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

January 11, 2016

Last Update Submit

April 16, 2018

Conditions

DepressionAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Parenting quality

    On average, 1 month after intervention

  • Child anxiety symptoms

    On average, 1 month after intervention

  • Child depressive symptoms

    On average, 1 month after intervention

  • Child anxiety

    On average, 1 month after intervention

  • Child depression

    On average, 1 month after intervention

Study Arms (2)

Parenting Intervention

EXPERIMENTAL

Parenting Intervention: Parent-Child Interaction Therapy (PCIT)

Behavioral: Parent Child Interaction Therapy (PCIT)

Waitlist Control

NO INTERVENTION

Waitlist Control Condition

Interventions

Parent Child Interaction Therapy (PCIT)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.

Parenting Intervention

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child is 6-7 years old
  • Maternal history of anxiety or depression
  • Maternal self-report of low positive/high harsh parenting

You may not qualify if:

  • Child has developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Kristin Bernard

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Bernard

CONTACT

6316327576kristin.bernard@stonybrook.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 29, 2016

Study Start

April 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

US(1)