Substance Use DisordersNCT02670902
Intervention for Persons Leaving Residential Substance Abuse Treatment
A study testing Critical Time Intervention-Residential (CTI-R) and Enhanced Usual Discharge Services-Residential in people with Substance Use Disorders, run by New York University at 1 site in United States.
Trial summary
This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Critical Time Intervention-Residential (CTI-R) and Enhanced Usual Discharge Services-Residential
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.
Who cannot join
- Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:
- Anyone under the age of 18
- Non-English speaking individuals due to limited resources
- Individuals who are considered vulnerable/protected populations, including children, pregnant women, and prisoners.
- Individuals judged by clinical treatment staff to be in immediate crisis, i.e., suicide watch or inadequate decisional capacity to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx
This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.
Read the detailed description
This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.
- Conditions
- Substance Use Disorders
- Being tested
- Critical Time Intervention-Residential (CTI-R), Enhanced Usual Discharge Services-Residential
- Keywords
- Residential substance use treatment, Transition
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Time Intervention-Residential (CTI-R)Behavioural
CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program.
Enhanced Usual Discharge Services-ResidentialBehavioural
The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services.
| Study group | Role | What they receive |
|---|---|---|
| Critical Time Intervention-Residential | Experimental | CTI-R is a 9-month, assertive outreach and linkage program. Receives: Behavioral: Critical Time Intervention-Residential (CTI-R); Behavioral: Enhanced Usual Discharge Services-Residential |
| Enhanced Usual Discharge-Residential | Active comparator | The enhanced usual discharge condition includes usual discharge services plus enhanced transition services. Receives: Behavioral: Enhanced Usual Discharge Services-Residential |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Proportion of participants enrolled in the study as measured by the research records
Measured: Baseline
Change in retention
Proportion of participants completed the study as measured by the research records
Measured: 3, 6, 9, and 12 months
Short-term Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Measured: 3 months
Use of aftercare services
Proportion of participants who were linked to aftercare services (i.e. substance use treatment) at the time of discharge as measured by the Treatment Service Review (TSR)
Measured: 3 months
Housing
Proportion of participants housed at the time of discharge
Measured: 3 months
Secondary outcomes (11)
Short-term Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Measured: 3 months
Short-term Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Measured: 3 months
Short-term Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Measured: 3 months
Change in Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Measured: 3, 6, and 9 months
Long-term Relapse
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Measured: 12 months
Change in Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Measured: 3, 6, and 9 months
Long-term Social Support
Level of social support as measured by the 8-item modified Medical Outcomes Study Social Support Survey
Measured: 12 months
Change in Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Measured: 3, 6, and 9 months
Long-term Self-Efficacy
Level of self-efficacy as measured by "I feel like I'm in control of my alcohol or drug use."
Measured: 12 months
Change in Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Measured: 3, 6, and 9 months
Long-term Mental Health
Level of mental health severity as measured by the Brief Symptom Inventory
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start1 May 2017
- Primary completion1 May 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer I Manuel, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670902
- Sponsor's protocol ID
- K01DA035330
- Status last verified
- May 2022
- First submitted
- 25 Jan 2016
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Persons With Co-Occurring Disorders Leaving Residential Tx
- ClinicalTrials.gov ID
- NCT02670902
- Acronym / sponsor ID
- K01DA035330
- Conditions
- Substance Use Disorders
- Keywords
- Residential substance use treatment, Transition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research uses a multi-phase approach to adapt and implement an established intervention, Critical Time Intervention, for a new population and setting among individuals with substance use who are at risk of relapse following residential substance abuse treatment. The goals of the study are to: (PHASE 1) identify challenges and strategies of community reentry among individuals in residential substance abuse treatment and their providers and social support networks (e.g., family, friends, community members); (PHASE 2) adapt CTI for individuals in residential substance abuse treatment to prepare them for discharge and transition back into the community; and (PHASE 3) conduct a pilot study to examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services.
Detailed description
This randomized pilot study will examine the feasibility, acceptability, and preliminary outcomes of the adapted CTI compared to enhanced usual discharge planning services. More specifically, 60 participants will be randomized to either CTI (n=30) or enhanced usual discharge planning services (n=30) at the time of discharge. Participants will complete a baseline interview (prior to randomization) and 3-, 6-, 9- and 12-month follow-up assessments post-discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critical Time Intervention-Residential | Experimental | Behavioral: Critical Time Intervention-Residential (CTI-R), Behavioral: Enhanced Usual Discharge Services-ResidentialCTI-R is a 9-month, assertive outreach and linkage program. |
| Enhanced Usual Discharge-Residential | Active comparator | Behavioral: Enhanced Usual Discharge Services-ResidentialThe enhanced usual discharge condition includes usual discharge services plus enhanced transition services. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be enrolled in residential substance abuse treatment and who are at least 18 years of age, speak English, and expect to be discharged within 3 months.
Key exclusion criteria (5 listed)
- Individuals that do not meet the aforementioned inclusion criteria will be excluded from the study.More specifically, the following categories will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical Time Intervention-Residential (CTI-R)CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program. | Behavioural | Critical Time Intervention-Residential |
| Enhanced Usual Discharge Services-ResidentialThe enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program plus enhanced transition services. | Behavioural | Critical Time Intervention-Residential, Enhanced Usual Discharge-Residential |
Primary outcome
Enrollment
Time frame: Baseline
Proportion of participants enrolled in the study as measured by the research records
Change in retention
Time frame: 3, 6, 9, and 12 months
Proportion of participants completed the study as measured by the research records
Short-term Relapse
Time frame: 3 months
Proportion of participants who relapsed (i.e., substance use) as measured by Addiction Severity Index
Use of aftercare services
Time frame: 3 months
Proportion of participants who were linked to aftercare services (i.e. substance use treatment) at the time of discharge as measured by the Treatment Service Review (TSR)
Housing
Time frame: 3 months
Proportion of participants housed at the time of discharge
11 secondary outcomes
Short-term Social Support
Time frame: 3 months
Short-term Self-Efficacy
Time frame: 3 months
Short-term Mental Health
Time frame: 3 months
Change in Relapse
Time frame: 3, 6, and 9 months
Long-term Relapse
Time frame: 12 months
Change in Social Support
Time frame: 3, 6, and 9 months
Long-term Social Support
Time frame: 12 months
Change in Self-Efficacy
Time frame: 3, 6, and 9 months
Long-term Self-Efficacy
Time frame: 12 months
Change in Mental Health
Time frame: 3, 6, and 9 months
Long-term Mental Health
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer I Manuel, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical Time Intervention-Residential (CTI-R) and Enhanced Usual Discharge Services-Residential in people with Substance Use Disorders, run by New York University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.