Safe Babies: Parenting Action Plan ( PAP )

Parenting Clinical Trial

— PAP  

Official title:

Safe Babies Parenting Action Plan RCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467371
• Other study ID #: HSC-SPH-23-1042
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Dorothy Mandell, PhD
• Phone: (512) 482-6160
• Email: Dorothy.J.Mandell[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Motivational Interviewing
• Parenting

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Assess patient's Satisfaction level with the educational resource	Questionnaire developed to assess the parent's satisfaction with the resource	Immediately post intervention