Safe Babies: Parenting Action Plan ( PAP )

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2025-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tips for Infant and Parent Sleep (TIPS)

NCT00228215

Sleep Deprivation

COMPLETED NA

Improving the Self-Efficacy of African American Parents in Infant Supine Sleep

NCT01707173

African American Infant Sleep Beliefs and Practices

COMPLETED NA

Measuring and Reducing Excessive Infant Crying

NCT01217658

Infant Colic Postpartum Depression

COMPLETED NA

Effective Analgesia During Routine Immunizations

NCT01368861

Pain

COMPLETED

Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates

NCT06318637

Newborn

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this project is to evaluate whether prevention education using motivational interviewing focused on promoting positive maternal mental health, coping with inconsolable crying, life stress reduction, and positive coping strategies with difficult infant behavior can provide complimentary messaging that supports positive parental behavior and reduces risks associated with poor mental health and infant maltreatment. The goal is to examine the efficacy of the Parenting Action Plan (PAP), a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. It is delivered using motivational interviewing techniques. This study is not designed to develop education for "at-risk" individuals, rather the purpose is to develop a populationlevel prevention program.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parenting Motivational Interviewing Maltreatment/Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is designed as a randomized controlled trial with maternal caregivers of infants 2 months and younger. Maternal caregivers who consent to be in the study will be randomized into one of two groups. One group will get Safe Kids home safety education and the other group will receive the Parenting Action Plan with motivational interviewing techniques.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

All data will be blinded prior to analysis. The outcomes assessor will not know study allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parenting Action Plan

The parenting action plan is a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby. Maternal caregivers will receive the booklet via mail and a trained research staff member will virtually go over the booklet using motivational interviewing strategies

Group Type EXPERIMENTAL

Parenting Action Plan

Intervention Type BEHAVIORAL

The parenting action plan a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.

Safe Kids Home Safety Checklist

The Safe Kids Home Safety Checklist is a handout with information that focuses on home safety for parents of young children. Maternal caregivers will receive the handout via mail and a trained research staff member will virtually go over the handout with the parent using educational strategies.

Group Type ACTIVE_COMPARATOR

Safe Kids Home Safety Checklist

Intervention Type BEHAVIORAL

Safe Kids created a home safety checklist to help keep kids safe, room by room.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parenting Action Plan

The parenting action plan a booklet with information that focuses on sleep hygiene, soothing a crying baby, what to do when the baby's crying is overwhelming, identifying safe caregivers in case of emergency, and issues surrounding feeding and bonding with the baby.

Intervention Type BEHAVIORAL

Safe Kids Home Safety Checklist

Safe Kids created a home safety checklist to help keep kids safe, room by room.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* maternal caregivers of infant 2 months and younger
* can read and speak English or Spanish
* has zoom / teams / facetime / google hangout capability