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OpenTrials
Completed

NCT Number: NCT05467371

Safe Babies: Parenting Action Plan ( PAP )

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.

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Key information

Conditions

Parenting Maltreatment/Abuse Motivational Interviewing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baylor College of Medicine, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Safe Kids Home Safety Checklist

Behavioral

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

Primary outcomes

  1. Parental Attributions change from 6 to 12 weeks post intervention

    Time frame: 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.

  2. Parental competency change from 6 to 12 weeks post intervention

    Time frame: 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."

  3. Maternal depression change from 6 to 12 weeks post intervention

    Time frame: 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.

  4. Maternal bonding change from 6 to 12 weeks post intervention

    Time frame: 6 and 12 weeks post intervention

    This self-report measure assesses how the parent feels about their infant and is a proxy for bonding.

  5. Cognitive stimulation in the home change from 6 to 12 weeks post intervention

    Time frame: 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.

Secondary outcomes

  1. Assess patient's Satisfaction level with the educational resource

    Time frame: Immediately post intervention

    Questionnaire developed to assess the parent's satisfaction with the resource

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Safe Babies Parenting Action Plan RCT

Acronym: PAP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2022
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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