Parenting Action Plan for new mothers
Safe Babies Parenting Action Plan RCT
This study tests whether a helpful booklet for new mothers can improve their parenting skills and mental health while reducing stress and the risk of harming their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 3 sites (Houston, Texas and 2 other locations) |
| Trial ID | NCT05467371 on ClinicalTrials.gov |
What this trial studies
This project evaluates the effectiveness of the Parenting Action Plan (PAP), which is a booklet designed to educate maternal caregivers of infants on essential topics such as sleep hygiene, soothing techniques for crying babies, and identifying safe caregivers. The intervention employs motivational interviewing to promote positive maternal mental health and coping strategies for managing stress and difficult infant behaviors. The study aims to provide population-level prevention education rather than targeting at-risk individuals, focusing on enhancing parental behaviors and reducing the risk of infant maltreatment.
Who should consider this trial
Good fit: Ideal candidates are maternal caregivers of infants aged 2 months or younger who can communicate in English or Spanish and have access to virtual communication tools.
Not a fit: Patients with infants older than 2 months or those without virtual communication capabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve maternal mental health and reduce the risk of infant maltreatment.
How similar studies have performed: Other studies utilizing motivational interviewing for parenting education have shown promise, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 2 other locations
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- University of Texas Health Science Center at Tyler — Tyler, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dorothy Mandell, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Dorothy Mandell, PhD
- Email: Dorothy.J.Mandell@uth.tmc.edu
- Phone: (512) 482-6160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.