Holistic Assessment of Tulsa Children's Health

NCT04158089 | Completed

• 1 other identifier: HS1871
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to rapidly increase maternal-fetal bonding, a strong predictor of maternal health practices during pregnancy, through an intervention, BLOOM (Babies and Moms, connected by Love, Openness, and Opportunity). Specifically, the investigators will examine change in maternal-fetal bonding across pregnancy and implications for change in maternal smoking during pregnancy using a randomized clinical trial design in a longitudinal, multi-ethnic cohort study of 160 women (ages 18 or older) who are 12-16 weeks pregnant. Participants will be randomly assigned into one of two groups for the intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment/mindfulness exercises. Participants will complete an in-depth initial assessment that includes sociodemographic measures as well as a battery to capture maternal-fetal bonding and self-reported smoking. Pre- and post-tests will be used to assess maternal-fetal bonding and smoking before and after the intervention to allow for examination of change across pregnancy. The positive impacts of this work include information that will be used to reduce the impact of unintended pregnancy for adverse infant health outcomes.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Maternal-Fetal Attachment at 4 months

  Maternal-Fetal Attachment Scale (MFAS) is a 24-item, Likert type, self-rated scale with five subscales (Cranley, 1981)

  Through study completion, an average of 1 year

• Change from Baseline Self-Reported Smoking Status at 4 months

  Survey questions asking about frequency, type (vaping vs. combustible); cannabis vs. tobacco; amount (relevant for vaping)

  Through study completion, an average of 1 year

Study Arms (2)

No intervention

NO INTERVENTION

Participants in the "No intervention" group will receive treatment (e.g., prenatal care) as usual.

Attachment Exercises

EXPERIMENTAL

Participants in the "Attachment Exercises" group will receive daily texts over the 2-week intervention period with activities to do from home that are designed to increase feelings of attachment (e.g., read a children's book aloud; sing a nursery rhyme; picture giving the baby a bath; tell the baby a story; etc.).

Behavioral: Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)

Interventions

Babies and Moms connected through Love, Openness, and Opportunity (BLOOM) BEHAVIORAL

Participants will be randomly assigned into one of two groups for the BLOOM intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment exercises to complete from home. The intervention will take place over a 2-week period. Participants in the "Attachment Exercises" group will receive a text every day with an activity designed to increase feelings of attachment (e.g., read a children's book; sign a nursery rhyme; picture giving your baby a baby; tell your baby a story, etc.).

Attachment Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Between 12-16 weeks pregnant at the time of enrollment.

You may not qualify if:

• Unable to communicate in either English or Spanish
• Planning to either terminate the pregnancy or place the baby for adoption.

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma Center for the Advancement of Science and Technology: collaborator

Study Sites (1)

OU Women's Health and Specialty Clinic

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (4)

• Cranley MS. Development of a tool for the measurement of maternal attachment during pregnancy. Nurs Res. 1981 Sep-Oct;30(5):281-4.

  PMID: 6912989 BACKGROUND

• Wise A, Geronimus AT, Smock PJ. The Best of Intentions: A Structural Analysis of the Association between Socioeconomic Disadvantage and Unintended Pregnancy in a Sample of Mothers from the National Longitudinal Survey of Youth (1979). Womens Health Issues. 2017 Jan-Feb;27(1):5-13. doi: 10.1016/j.whi.2016.10.006. Epub 2016 Nov 29.

  PMID: 27913056 BACKGROUND

• Massey SH, Bublitz MH, Magee SR, Salisbury A, Niaura RS, Wakschlag LS, Stroud LR. Maternal-fetal attachment differentiates patterns of prenatal smoking and exposure. Addict Behav. 2015 Jun;45:51-6. doi: 10.1016/j.addbeh.2015.01.028. Epub 2015 Jan 20.

  PMID: 25644587 BACKGROUND

• Shreffler KM, Tiemeyer S, Ciciolla L, Croff JM. Effect of a mindfulness-based pilot intervention on maternal-fetal bonding. Int J Womens Health. 2019 Jun 21;11:377-380. doi: 10.2147/IJWH.S203836. eCollection 2019.

  PMID: 31417321 BACKGROUND

Study Officials

• Karina M Shreffler, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the behavioral design of the intervention, it is impossible to mask participants (who are asked to do tasks) or investigators (who train participants and contact them about tasks). However, care providers are not involved in the study, and the statistical analyses will be conducted with a de-identified data set.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This intervention examines whether the use of texted attachment exercises to effectively increase maternal prenatal bonding.

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 8, 2019
• Study Start: December 20, 2021
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Researchers will be able to request limited (e.g., non-identifying) IPD at the time of publication.
• Access Criteria: Researchers must request IPD directly from PI Shreffler for access. Data published will be uploaded to FigShare, which allows the PI to securely provide a researcher with access to the data.

Locations

US (1)