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Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children

NCT ID: NCT04160013

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

533 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2019-01-19

Brief Summary

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The aim is to determine if a brief intervention can affect parents' attitudes about physical punishment and other parenting behaviors.

Detailed Description

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A public health problem that needs to be solved is how to educate more parents about healthy discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by integrating evidence-based parent training into pediatric primary care. Some of the most modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The investigators define unhealthy parenting behaviors such as spanking, threatening, yelling, and humiliation. For adults in the original ACEs study, it was exposure to these behaviors that led to the categorization of child abuse/neglect and that were associated with heart disease, obesity, depression, smoking, drug use, violence, and many other problems. This study may help change policy and practice related to mitigating ACEs in primary care. To accomplish this goal, randomized controlled trials are needed to test brief screening tools and evidence-based resources. A population-based approach is needed to reach all parents (i.e. primary prevention). In the study, parents in the intervention group will receive 3 minutes of education about healthy discipline strategies.

Conditions

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Parenting Violence Child Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking.

Study Groups

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Discipline education

Education about discipline using the Play Nicely program (www.playnicely.org).

Group Type EXPERIMENTAL

Discipline education

Intervention Type BEHAVIORAL

Discipline education using the Play Nicely program.

Cavity prevention

Education about cavity prevention using a 2 page handout.

Group Type PLACEBO_COMPARATOR

Cavity Prevention

Intervention Type BEHAVIORAL

Cavity prevention using a 2 page handout.

Interventions

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Discipline education

Discipline education using the Play Nicely program.

Intervention Type BEHAVIORAL

Cavity Prevention

Cavity prevention using a 2 page handout.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Parents of 6 month to 2 year old children presenting to the Vanderbilt Pediatric Primary Care Clinic for a well visit or an acute care visit.

Exclusion Criteria

* Parents who do not speak and read English, Spanish, or Arabic. The interventions are only available in English, Spanish, and Arabic.
Minimum Eligible Age

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seth Scholer

Professor of Pediatrics and Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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171485

Identifier Type: -

Identifier Source: org_study_id