NCT05864027

Brief Summary

The aim of the study is to test a brief, peer-led group-based oral health educational intervention - called the "Oral Health Recovery Group" - designed for individuals with psychiatric disabilities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

April 12, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

April 12, 2023

Last Update Submit

March 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average subject-level change between pre- and post-surveys

    To analyze process data generated by the peers, a custom web-based Peer Encounter Form will be employed using Qualtrics Survey Software. Peers will complete encounter forms after each group and follow up. Fields include time spent, unique and total encounters, topics covered, participant engagement, and any knowledge of participants' seeking out or utilizing dental care. The primary analyses will compare the change in total scores on an oral health knowledge questionnaire and an oral health confidence/activation questionnaire based primarily on the transtheoretical model of change. These comparisons will be conducted as a comparison of the average subject-level improvements between pre- and post-surveys ("change scores") between the primary intervention (peer-led Oral Health Recovery Group) and the comparator video intervention.

    2 months

Secondary Outcomes (1)

  • Odds ratio of participants who reported seeking dental care

    2 months

Study Arms (2)

Peer-led Oral Health Recovery educational group

EXPERIMENTAL
Behavioral: Peer-led Oral Health Recovery Group

Educational Video

ACTIVE COMPARATOR
Behavioral: Educational Video about Oral Health

Interventions

The interactive Oral Health Recovery group will be centered around the tailored materials previously developed, with topics such as "it's never too late to make a change," "oral health and whole health," "taking care of your teeth," and "going to the dentist."

Peer-led Oral Health Recovery educational group

The video comparison will be pulled from Toothflix 2.0 Patient Education DVD Series, which are patient education videos developed by the American Dental Association.

Educational Video

Eligibility Criteria

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

You may qualify if:

  • An adult member/consumer with the selected site (JIMHO or Washtenaw CMH)
  • Ability to understand and willingness to read a consent terms handout and discussion
  • Participant must understand/read/speak English

You may not qualify if:

  • Not a member/consumer with the site
  • Not able to understand and/or not willing to read consent terms handout
  • Does not understand/read/speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Justice in Mental Health Organization (JIMHO)

Lansing, Michigan, 48933, United States

Location

Community Mental Health (Towner)

Ypsilanti, Michigan, 48198, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Adrienne Lapidos, PhD

    University of Michigan Medical School, Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Psychiatry

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 18, 2023

Study Start

April 13, 2023

Primary Completion

December 7, 2023

Study Completion

December 20, 2023

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations