AddictionNCT01632735

Mobile Continuing Care Approach for Youth

A study testing Mobile Continuing Care in people with Addiction, run by Azusa Pacific University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to test the effectiveness of a pilot mobile based continuing care program (monitoring/feedback texting) relative to standard continuing care as usual in reducing relapse and improving psychosocial functioning outcomes in a youth population (under 24) with substance abuse problems. Read more about this study

Who is it for?: Ages 12 to 24 years
Conditions the study is for: Addiction
What is being tested?: Mobile Continuing Care
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Youth between 12 and 24 years old
Youth in treatment for substance abuse
Youth who complete treatment (minimum 12 weeks)
Youth who have the cognitive capacity to understand study procedures and agree to participate

Who cannot join

Presence of an adverse (life threatening) medical condition that could interfere with study participation.
Presence of psychiatric co-occurring illness or symptoms warranting safety concerns or continued treatment, including acute suicide risk; and
Current homelessness (unless residing in recovery home for which contact information can be provided).

Trial locations and contacts

1 site in 1 country.

United States1 site

Azusa Pacific University Psychology Department
Azusa, California, 91702

Other trials in United States

About this study

Read the detailed description

This study will include approximately 80 participants randomized to either 12 weeks of mobile continuing care (intervention) or standard continuing care as usual (control). Participants will be recruited from the treatment programs in Los Angeles County, including Matrix Institute on Addictions, Tarzana Treatment, Twin Town, Phoenix House, and Cri-Help. During the 12-week active program, participants will be monitored monthly via telephone data collection. Both groups will be followed for 10-months using repeated assessments (self-report and urine specimens) at baseline (month 0) and at follow-up points (months 3, 6, and 9).

Conditions: Addiction
Being tested: Mobile Continuing Care
Keywords: Continuing Care, Youth Substance Abuse, Recovery Support, Mobile Texting
Medical subject headings: Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile Continuing CareBehavioural
Behavioral: Mobile Texting 12-week intervention. Delivers daily Recovering monitoring, self-management feedback, and education/social support

Study groups in NCT01632735
Study group	Role	What they receive
Mobile Continuing Care	Experimental	Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education Receives: Behavioral: Mobile Continuing Care
Standard Continuing Care as Usual	No intervention	Continuing care as usual to 12-step facilitation (Anonymous group)

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Substance Use (Defined as Substance Received Treatment for)
Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).
Measured: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up

Secondary outcomes (3)

Participation in Recovery Behaviors Over Time
Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.
Measured: baseline, discharge, 3-, 6- and 9-month follow-ups
Recovery Confidence (Self-efficacy) Over Time
Change/improvements in mean recovery confidence score over time (measured by question "How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days?" (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely).
Measured: baseline, discharge, 3-, 6-, and 9-month follow-ups
Social Support Utilization
Self-help utilization was measured by the question: "In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?"
Measured: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jun 2015

First posted3 Jul 2012 (estimated)
Study startFeb 2012
Primary completionDec 2014
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AddictionStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01632735
Sponsor's protocol ID: 5K01DA027754-03
Other IDs: 1K01DA027754-01A1
Status last verified: Jul 2015
First submitted: 29 Jun 2012
Last updated: 21 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Continuing Care Approach for Youth
ClinicalTrials.gov ID: NCT01632735
Acronym / sponsor ID: 5K01DA027754-03
Conditions: Addiction
Keywords: Continuing Care, Youth Substance Abuse, Recovery Support, Mobile Texting
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Azusa Pacific UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of California, Los Angeles
Study start: Feb 2012
Primary completion: Dec 2014 (actual)
Study completion: Jun 2015 (actual)
First posted: 3 Jul 2012 (estimated)
Results: Posted 21 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mobile Continuing Care	Experimental	Behavioral: Mobile Continuing CareBehavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education
Standard Continuing Care as Usual	No intervention	–Continuing care as usual to 12-step facilitation (Anonymous group)

Who may qualify

Ages: 12 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Youth between 12 and 24 years old
Youth in treatment for substance abuse
Youth who complete treatment (minimum 12 weeks)
Youth who have the cognitive capacity to understand study procedures and agree to participate

Key exclusion criteria (3 listed)

Presence of an adverse (life threatening) medical condition that could interfere with study participation.
Presence of psychiatric co-occurring illness or symptoms warranting safety concerns or continued treatment, including acute suicide risk; and
Current homelessness (unless residing in recovery home for which contact information can be provided).

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
Mobile Continuing CareBehavioral: Mobile Texting 12-week intervention. Delivers daily Recovering monitoring, self-management feedback, and education/social support	Behavioural	Mobile Continuing Care

Primary outcome

Primary Substance Use (Defined as Substance Received Treatment for)
Time frame: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up
Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).

3 secondary outcomes

Participation in Recovery Behaviors Over Time
Time frame: baseline, discharge, 3-, 6- and 9-month follow-ups
Recovery Confidence (Self-efficacy) Over Time
Time frame: baseline, discharge, 3-, 6-, and 9-month follow-ups
Social Support Utilization
Time frame: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up

Results and safety

Results posted to the registry on 21 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile Continuing Care	40	36
Standard Continuing Care as Usual	40	37

Primary outcome: Primary Substance Use (Defined as Substance Received Treatment for)

Time frame: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up. Number. Unit: percentage of positive urines

Measure	Mobile Continuing Care n = 40	Standard Continuing Care as Usual n = 40
baseline substance use	47.5	41.5
discharge substace use	14.7	62.9
3-month follow-up substace use	21.4	59.3
6-month follow-up substace use	16.7	50.0
9-month follow-up substace use	11.1	14.3

Mobile Continuing Care vs Standard Continuing Care as Usual: Odds Ratio (OR): 0.75 (95% CI 0.57 to 0.99), p <0.05, GEE

Population analysed: An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 9-month study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile Continuing Care	0 of 40 (0%)	0 of 40 (0%)	Not reported
Standard Continuing Care as Usual	0 of 40 (0%)	0 of 40 (0%)	Not reported

Limitations and caveats (from the sponsor): Pilot study limiting number of participants recruited.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Rachel Gonzales-Castaneda, MPH, PhD principal investigator

Azusa Pacific 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 Mobile Continuing Care in people with Addiction, run by Azusa Pacific 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 4 inclusion and 3 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 21 Aug 2015. 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?

Yes. Results are posted in the registry (first posted 21 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Substance Use (Defined as Substance Received Treatment for) (time frame: Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01632735.

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 21 Aug 2015.