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Safe Babies: Parenting Action Plan ( PAP )

Safe Babies Parenting Action Plan RCT

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05467371
Acronym
PAP
Enrollment
283
Registered
2022-07-20
Start date
2022-08-23
Completion date
2025-06-15
Last updated
2025-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maltreatment/Abuse, Motivational Interviewing, Parenting

Keywords

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

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.

Interventions

BEHAVIORALParenting 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.

BEHAVIORALSafe Kids Home Safety Checklist

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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

All data will be blinded prior to analysis. The outcomes assessor will not know study allocation.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parental Attributions change from 6 to 12 weeks post intervention6 and 12 weeks post interventionThe 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 intervention6 and 12 weeks post interventionParental 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 depression change from 6 to 12 weeks post intervention6 and 12 weeks post interventionAll 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.
Maternal bonding change from 6 to 12 weeks post intervention6 and 12 weeks post interventionThis 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 intervention6 and 12 weeks post interventionStimQ-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

MeasureTime frameDescription
Assess patient's Satisfaction level with the educational resourceImmediately post interventionQuestionnaire developed to assess the parent's satisfaction with the resource

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026