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PAP Booklet for Parenting Stress and Bonding (PAP Trial)

N/A
Recruiting
Led By Dorothy Mandell, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 weeks post intervention
Awards & highlights

PAP Trial Summary

This trial will test whether the PAP booklet is effective in reducing stress and improving bonding for parents of newborns.

Who is the study for?
This trial is for maternal caregivers of infants who are 2 months old or younger, able to read and speak English or Spanish, and have the ability to use video call platforms like Zoom, Teams, FaceTime, or Google Hangout. Caregivers under 18 years old or those with infants older than 2 months cannot participate.Check my eligibility
What is being tested?
The study tests the Parenting Action Plan (PAP), a guide designed to help new parents with sleep hygiene for babies, calming techniques for crying infants, emergency caregiver identification, feeding tips, and bonding advice. It also includes using the Safe Kids Home Safety Checklist.See study design
What are the potential side effects?
Since this trial involves educational materials and checklists rather than medical treatments or drugs, there are no physical side effects expected from participating in this study.

PAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 weeks post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive stimulation in the home change from 6 to 12 weeks post intervention
Maternal bonding change from 6 to 12 weeks post intervention
Maternal depression change from 6 to 12 weeks post intervention
+2 more
Secondary outcome measures
Assess patient's Satisfaction level with the educational resource

PAP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Parenting Action PlanExperimental Treatment1 Intervention
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
Group II: Safe Kids Home Safety ChecklistActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,677 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,001,952 Total Patients Enrolled
1 Trials studying Parenting
750 Patients Enrolled for Parenting
The University of Texas Health Science Center at TylerOTHER
14 Previous Clinical Trials
25,388 Total Patients Enrolled

Media Library

Parenting Action Plan Clinical Trial Eligibility Overview. Trial Name: NCT05467371 — N/A
Parenting Research Study Groups: Safe Kids Home Safety Checklist, Parenting Action Plan
Parenting Clinical Trial 2023: Parenting Action Plan Highlights & Side Effects. Trial Name: NCT05467371 — N/A
Parenting Action Plan 2023 Treatment Timeline for Medical Study. Trial Name: NCT05467371 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any volunteers being considered for this clinical experiment at present?

"Data from clinicaltrials.gov reveals that the recruitment phase for this medical trial has concluded; it was first posted on July 1st and last updated on July 18th 2022. Nevertheless, there are currently 102 other trials seeking participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
University of Texas Health Science Center at Tyler
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Baylor College of Medicine: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Safe Babies: Parenting Action Plan ( PAP )
Dorothy Mandell 2022. "Safe Babies: Parenting Action Plan ( PAP )". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467371.
~69 spots leftby Nov 2024
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