Safe Babies: Parenting Action Plan ( PAP )

Not Applicable

Completed

• Conditions: Maltreatment/Abuse; Motivational Interviewing; Parenting

• Registration Number: NCT05467371
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Study Start: 2022-08-23
• Primary Completion: 2025-05-01
• Status Verified: 2025-06
• Study Completion: 2025-06-15
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 283

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parental Attributions change from 6 to 12 weeks post intervention	6 and 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.
Parental competency change from 6 to 12 weeks post intervention	6 and 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."
Maternal bonding change from 6 to 12 weeks post intervention	6 and 12 weeks post intervention	This self-report measure assesses how the parent feels about their infant and is a proxy for bonding.
Cognitive stimulation in the home change from 6 to 12 weeks post intervention	6 and 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.
Maternal depression change from 6 to 12 weeks post intervention	6 and 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.

Secondary Outcome Measures

Name	Time	Method
Assess patient's Satisfaction level with the educational resource	Immediately post intervention	Questionnaire developed to assess the parent's satisfaction with the resource

Trial Locations

Locations (3)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States