Safe Babies: Parenting Action Plan ( PAP )

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safe Babies: Parenting Action Plan Efficacy Study

Conditions
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Parenting, Motivational Interviewing, Maltreatment/Abuse

Intervention / Treatment
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* Behavioral: Parenting Action Plan
* Behavioral: Safe Kids Home Safety Checklist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Action Plan<br>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<br>* 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.<br>|
| Active Comparator: Safe Kids Home Safety Checklist<br>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<br>* Safe Kids created a home safety checklist to help keep kids safe, room by room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess patient's Satisfaction level with the educational resource | Questionnaire developed to assess the parent's satisfaction with the resource | Immediately post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parenting education, maternal mental health, infant maltreatment, motivational interviewing