NCT06624332

Brief Summary

The goal of this study is to learn about whether digital screening and brief intervention can help address substance use in postpartum mothers who are enrolled in home visiting programs. The main questions it aims to answer are:

  1. 1.What combination of digital intervention components work best for postpartum mothers in home visiting programs?
  2. 2.What are the factors that help the intervention work best in home visiting, and what factors serve as barriers to the success of the intervention? Participants in the study will include home visiting staff and postpartum home visiting clients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

October 1, 2024

Last Update Submit

March 16, 2026

Conditions

Substance Use

Outcome Measures

Primary Outcomes (1)

  • Substance use

    Quantity and frequency of substance use, measured by the Timeline Follow Back Method. Higher scores indicate more substance use.

    Assessed at 3-month follow-up and 6-month follow-up

Secondary Outcomes (3)

  • Motivation to avoid substance use

    Assessed at 3-month follow-up and 6-month follow-up

  • Maternal self-efficacy

    Assessed at 3-month and 6-month follow-up

  • Home visiting retention

    Assessed at 6-month follow-up

Study Arms (6)

No intervention Routine HV Only

NO INTERVENTION

Routine home visiting only

e-SBI main session

EXPERIMENTAL

e-SBI main session

Behavioral: e-SBI main session

e-SBI main session + booster

EXPERIMENTAL

e-SBI main session and e-SBI booster session

Behavioral: e-SBI main sessionBehavioral: e-SBI Booster Session

Text messaging only

EXPERIMENTAL

text messaging

Behavioral: Text messaging

e-SBI main session + text messaging

EXPERIMENTAL

e-SBI main session Text messaging

Behavioral: e-SBI main sessionBehavioral: Text messaging

e-SBI main + e-SBI booster + text messaging

EXPERIMENTAL

e-SBI main session e-SBI booster session text messaging

Behavioral: e-SBI main sessionBehavioral: e-SBI Booster SessionBehavioral: Text messaging

Interventions

e-SBI main sessionBEHAVIORAL

Single 20-minute e-SBI session that includes screening followed by brief motivational intervention.

e-SBI main + e-SBI booster + text messaginge-SBI main sessione-SBI main session + boostere-SBI main session + text messaging
e-SBI Booster SessionBEHAVIORAL

A 20-minute booster e-SBI session that reinforces content from the main e-SBI session.

e-SBI main + e-SBI booster + text messaginge-SBI main session + booster
Text messagingBEHAVIORAL

4 weeks of daily automated text messages that reinforce content from the e-SBI main session.

Text messaging onlye-SBI main + e-SBI booster + text messaginge-SBI main session + text messaging

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIn order to be eligible, participants must have given birth to a baby in the prior year. Thus, their biological sex must be female, but biological females who express their gender identity in other ways are still eligible, as long as they gave birth to a baby in the prior year.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Age 18 years old or older
  • Gave birth to a baby within the prior year
  • Enrolled in a Healthy Families Kansas program with a participating home visitor
  • Not currently enrolled in substance use treatment

You may not qualify if:

  • Does not speak English
  • Under age 18 years
  • Did not give birth to a baby within the prior year
  • Not enrolled in a Healthy Families Kansas program with a participating home visitor
  • Currently enrolled in substance use treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Central Study Contacts

Sarah Dauber, PhD

CONTACT

212-841-5270sdauber@toendaddiction.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03