Safe Babies: Parenting Action Plan ( PAP )

NCT05467371 | Completed

• 1 other identifier: HSC-SPH-23-1042
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 3

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.

Conditions

Parenting; Motivational Interviewing; Maltreatment/Abuse

Keywords

parenting education; maternal mental health; infant maltreatment; motivational interviewing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Assess patient's Satisfaction level with the educational resource

  Immediately post intervention

Study Arms (2)

Parenting Action Plan

EXPERIMENTAL

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

Safe Kids Home Safety Checklist

ACTIVE COMPARATOR

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

Interventions

Parenting Action Plan 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.

Parenting Action Plan

Safe Kids Home Safety Checklist BEHAVIORAL

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

Safe Kids Home Safety Checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (3)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75799, United States

Location

Study Officials

• Dorothy Mandell, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data will be blinded prior to analysis. The outcomes assessor will not know study allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 20, 2022
• Study Start: August 23, 2022
• Primary Completion: May 1, 2025
• Study Completion: June 15, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)