NCT02214667

Brief Summary

Treatment adaptation and implementation study for adult jail inmates with co-occurring substance use disorders.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

August 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

May 21, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

4.1 years

First QC Date

August 10, 2014

Last Update Submit

March 13, 2020

Conditions

Co-occurring Mental and Substance Use DisordersCrimeCriminogenic ThinkingImplementationAdaptation

Keywords

Jailco-occurring disordersimplementationacceptabilityfeasibilityfidelity

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    Client Satisfaction Questionnaire-8, Narrative Evaluation of Intervention Interview

    Study months 21 through 34

Secondary Outcomes (10)

  • Feasibility of Adapted Interventions

    Study months 21 through 34

  • Fidelity

    Study months 21 through 34

  • Substance use

    Study months 20 through 30

  • Psychiatric symptoms

    Study months 20 through 30

  • Health status

    Study months 20 through 30

  • +5 more secondary outcomes

Study Arms (2)

DDMI-IGT

EXPERIMENTAL

Subjects randomized to the experimental condition will receive adapted versions of dual-diagnosis motivational interviewing (\[DDMI\] one session before release from jail) and integrated group therapy (\[IGT\] 12 community-based sessions over a 2-month period).

Behavioral: Dual-diagnosis motivational interviewing (DDMI)Behavioral: Integrated group therapy (IGT)

Usual care

ACTIVE COMPARATOR

Subjects randomized to the usual care condition will receive jail and community-based behavioral health services.

Behavioral: Jail and community-based behavioral health services

Interventions

Dual-diagnosis motivational interviewing (DDMI)BEHAVIORAL

DDMI is an evidence-based adaptation to motivational interviewing. DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.

DDMI-IGT
Integrated group therapy (IGT)BEHAVIORAL

IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.

DDMI-IGT
Jail and community-based behavioral health servicesBEHAVIORAL

Existing behavioral health service programs

Usual care

Eligibility Criteria

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

You may qualify if:

  • (1) drug or alcohol abuse or dependence and SMI (major depressive disorder; depressive disorder not otherwise specified \[NOS\]; bipolar disorder I, II, or NOS; schizophrenia spectrum disorder; schizoaffective disorder; schizophreniform disorder; brief psychotic disorder; delusional disorder; or psychotic disorder NOS);
  • (2) resident of Wake County and detained in The Jail;
  • (3) \>18 years of age; (4) able to speak/read English; and (5) able to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

  • Van Dorn RA, Desmarais SL, Rade CB, Burris EN, Cuddeback GS, Johnson KL, Tueller SJ, Comfort ML, Mueser KT. Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial. Trials. 2017 Aug 4;18(1):365. doi: 10.1186/s13063-017-2088-z.

    PMID: 28778175DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Jails

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Correctional FacilitiesNon-Medical Public and Private Facilities

Study Officials

  • Richard A Van Dorn, Ph.D.

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2014

First Posted

August 12, 2014

Study Start

May 21, 2015

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)