The Rewire Study (Mindfulness Mobile App to Reduce Adolescent Substance Use)

Adolescent Substance Use Clinical Trial

Official title:

Mindfulness Mobile App to Reduce Adolescent Substance Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533491
• Other study ID #: DA043288-01
• Secondary ID: 1R43DA043288-01
• Status: Completed
• Phase: N/A
• Start date: March 30, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: May 2024
• Source: Oregon Research Behavioral Intervention Strategies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current proposal is aimed at developing a substance use cessation app (Rewire) for high risk adolescents who are involved in the juvenile justice system. The Rewire app will be based on the primary substance use cessation components tested in our previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation.

Description:

The Rewire Study will recruit 60 youth (30 boys and 30 girls) who have had contact with the Department of Youth Services in the last year. Consent will be obtained from parents or guardians for the youths' participation. The participating teens will come to Oregon Research Institute for a baseline assessment. During this visit, the teens will complete an assent form and spend 20-30 minutes completing an online survey with an assessor; topics covered in the survey include emotion regulation and drug and alcohol use. Teens will have the app loaded onto their phones and be provided with instructions for its use during this visit. Participants are asked to use the app over the next 2 weeks, completing 4 modules and spending 5-10 minutes each day answering questions about recent emotions and substance use. Teens will be contacted via email for follow up assessments at 2 weeks and 8 weeks post-baseline. These emails will contain links to the follow-up surveys which also ask about emotion regulation and drug and alcohol use; surveys should take 20-30 minutes to complete.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• ages 13 to 18
• involved with Juvenile Justice system
• documented substance use
• English-speaking
• living in the community

Exclusion Criteria:

• non English-speaking
• living in treatment or detention facility

Related Conditions & MeSH terms

• Adolescent Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Rewire App
A prototype Rewire app will be designed and created; the first four modules will be evaluated by 60 high-risk adolescents. The teens are asked to complete each module and spend a few minutes each day for two weeks using the practice exercises.

Locations

Country	Name	City	State
United States	Oregon Research Behavioral Intervention Strategies, Inc./Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Behavioral Intervention Strategies, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Adolescent Use of Cigarettes and E-Cigarettes	Change in nicotine use (frequency of use and quantity consumed) as measured by Youth Substances Interview	Baseline, 2 weeks, 8 weeks
Primary	Changes in Adolescent Use of Alcohol	Change in alcohol use (frequency of use and quantity consumed) as measured by Youth Substances Interview	Baseline, 2 weeks, 8 weeks
Primary	Changes in Adolescent Use of Marijuana	Change in marijuana use (frequency of use and quantity consumed) as measured by Youth Substances Interview	Baseline, 2 weeks, 8 weeks
Primary	Changes in Adolescent Use of Other Recreational Substances	Change in recreational substance use as measured by Youth Substances Interview	Baseline, 2 weeks, 8 weeks
Secondary	Changes in Adolescent Attitudes toward Substance Use	Adolescent Attitudes toward Substance Use measures beliefs about social norms and consequences. Scores are 0 to 10 with higher scores representing more prosocial attitudes.	Baseline, 2 weeks, 8 weeks
Secondary	Changes in Adolescent Mindfulness Practices	Mindfulness is measured by the Five Facet Mindfulness Questionnaire. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Maximum score is 40 for the first 4 scales and 35 for the last. Higher scores indicate a greater tendency toward each element of mindfulness.	Baseline, 2 weeks, 8 weeks
Secondary	Changes in Emotion Regulation	Emotion Regulation is measured by the Difficulties in Emotion Regulation Scale. Higher scores indicate greater problems with emotion regulation. Total score will range from 77 to 121.	Baseline, 2 weeks, 8 weeks
Secondary	Evaluate first 4 modules of prototype app	Participant satisfaction ratings are collected through interview questions	Intervention period (time of app use) is from Baseline to 2 week follow up