Clinical trial NCT05467371: Safe Babies: Parenting Action Plan ( PAP )
Official title: Safe Babies Parenting Action Plan RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Motivational Interviewing
Maltreatment/Abuse
Keywords: parenting education
maternal mental health
infant maltreatment
motivational interviewing
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental Attributions change from 6 to 12 weeks post intervention
timeFrame: 6 and 12 weeks post intervention
measure: Parental competency change from 6 to 12 weeks post intervention
timeFrame: 6 and 12 weeks post intervention
measure: Maternal depression change from 6 to 12 weeks post intervention
timeFrame: 6 and 12 weeks post intervention
measure: Maternal bonding change from 6 to 12 weeks post intervention
timeFrame: 6 and 12 weeks post intervention
measure: Cognitive stimulation in the home change from 6 to 12 weeks post intervention
timeFrame: 6 and 12 weeks post intervention
Secondary outcomes:
measure: Assess patient's Satisfaction level with the educational resource
timeFrame: Immediately post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Dorothy Mandell, PhD
role: PRINCIPAL_INVESTIGATOR
References: