Safe Babies: Parenting Action Plan ( PAP ) (PAP)

Safe Babies Parenting Action Plan RCT

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.

Study Overview

• Status: Completed
• Conditions: Parenting; Motivational Interviewing; Maltreatment/Abuse
• Intervention / Treatment: Behavioral: Parenting Action Plan; Behavioral: Safe Kids Home Safety Checklist

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 283
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Tyler, Texas, United States, 75799
      • University of Texas Health Science Center at Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• infant is older than 2 months of age
• under 18 years of age
• no video/virtual capability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
Active Comparator: 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.	Behavioral: Safe Kids Home Safety Checklist; Safe Kids created a home safety checklist to help keep kids safe, room by room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Attributions change from 6 to 12 weeks post intervention	The Parent Attribution Test will be used to assess maltreatment risk. This survey was chosen because it has been shown to be predictive of maltreatment in high risk families27. Further, this survey is relatively immune to social desirability bias28, partially because it does not specifically ask parents about their own parenting practices.	6 and 12 weeks post intervention
Parental competency change from 6 to 12 weeks post intervention	Parental competency will be measured using the Infant Characteristics Questionnaire29. The Infant Characteristics Questionnaire measures infant temperament. It is being included because difficult infants can impact how parents assess their own parental competency. Further, "difficult" infants are also at a higher risk for maltreatment. This measure will allow us to assess whether the PAP can help increase self-assessed competency, but also whether these self-assessed competencies increase for mothers who have infants that are more "difficult."	6 and 12 weeks post intervention
Maternal depression change from 6 to 12 weeks post intervention	All women will be screened for depression using the Edinburg Postnatal Depression Scale34. It is important to clarify that the mothers will be screened for the study separate from the screening she will receive in the clinic. We will be assessing depression risk separately so that the medical record will not need to be used for research, nor will research information be used to inform medical decisions.	6 and 12 weeks post intervention
Maternal bonding change from 6 to 12 weeks post intervention	This self-report measure assesses how the parent feels about their infant and is a proxy for bonding.	6 and 12 weeks post intervention
Cognitive stimulation in the home change from 6 to 12 weeks post intervention	StimQ-I is a 43 point scale for measuring cognitive stimulation in the homes of infants ages 5 to 12 months. It is based on a questionnaire that is administered to the child's primary caregiver.	6 and 12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess patient's Satisfaction level with the educational resource	Questionnaire developed to assess the parent's satisfaction with the resource	Immediately post intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: The University of Texas Health Science Center at Tyler
• Investigators: Principal Investigator: Dorothy Mandell, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: parenting education; maternal mental health; infant maltreatment; motivational interviewing
• Other Study ID Numbers: HSC-SPH-23-1042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No