NCT06303804

Brief Summary

The purpose of this study is to develop culturally-competent family-focused educational modules targeting opioid knowledge and attitudes (including targeting safe storage and prevention of accidental opioid overdose in adolescent populations) and examine changes acceptability, knowledge, and attitudes scores

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 4, 2024

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Acceptability of the educational materials presented via the educational videos, including cultural congruence as assessed by a questionnaire

    This questionnaire has 10 questions that is measured on a Likert scale from 1-4, higher number indicating more acceptability.

    end of study (Day 7)

  • Changes in opioid related knowledge as assessed by a questionnaire

    This has 3 subscales 1. Brief Opioid Overdose Knowledge (BOOK) This has 12 questions and each is scored from 0(true), 1(false) for a maximum score of 12, higher score indicating more knowledge 2. Opioid Overdose Knowledge Scale (OOKS) This has 9 questions, and participants have to identify all correct answers. Score ranges from 0(no correct answers) -33 (identified all correct answers) higher score indicates more knowledge 3. Opioid Overdose Attitude Scale (OOAS) This has 28 questions scored on a Likert scale from 1(completely disagree)-5(completely agree), higher number indicating more positive attitude

    Baseline, end of study (Day 7)

Study Arms (1)

Educational videos arm

EXPERIMENTAL
Behavioral: Educational videos

Interventions

Participants will be delivered a link to complete demographic information and the initial assessment. Upon completing the (initial) pre-test knowledge assessment, participants will be sent links to the three educational videos staggered across 7 days. Educational videos will determine gaps in knowledge related to opioid use and overdose based on questionnaire responses. Upon the completion of the 7 days, participants will be sent a link to the (final) post-test knowledge assessment to complete.

Educational videos arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must identify as Hispanic/Latino/a descent
  • Have an adolescent between the ages of 15 and 17 years old living in their home a majority of the time
  • Have English or Spanish proficiency

You may not qualify if:

  • Adolescent or parent currently in opioid treatment
  • Parent self-reports a substance use (including opioid use) disorder for themselves or adolescent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alejandra Fernandez, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Fernandez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

May 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations