Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395467
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
12-Step FacilitationMETCBT InTEGRA vs METCBT for Youth With Alcohol and Other Drug Use Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Integrated Treatment for Enhancing Growth in Recovery During Adolescence InTEGRA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InTEGRA
Brief Summary:
This is a Phase II parallel group randomized controlled trial with 294 adolescents age 14-21 years with alcohol and other drug AOD use disorder hereafter substance use disorder that compares two different active psychosocial interventions designed to address adolescent substance use disorder Participants are recruited from our clinical settings and the community at two sites one in the metro Boston Massachusetts MA area and the other in the metro Farmington Connecticut CT area
Study aims and hypotheses are as follows
1 To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence InTEGRA which integrates 12-Step Facilitation TSF with Motivational Enhancement TherapyCognitive Behavioral Therapy METCBT relative to gold standard METCBT alone N 294 It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment higher abstinence rates and fewer substance-related negative consequences
2 Investigate the personal recovery capital PRC and social recovery capital SRC mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time eg PRC motivation self-efficacy coping SRC 12-step involvement social network changes
3 Investigate moderators of InTEGRAs effects on outcomes across one-year follow-up eg effect of age network support for AOD use psychiatric severity age composition of 12-step meetings on substance use and substance-related consequences It is hypothesized that higher network support for AOD use abstinence motivation and greater AOD severity will have a better response to InTEGRA
4 Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design
Study aims and hypotheses are as follows
1 To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence InTEGRA which integrates 12-Step Facilitation TSF with Motivational Enhancement TherapyCognitive Behavioral Therapy METCBT relative to gold standard METCBT alone N 294 It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment higher abstinence rates and fewer substance-related negative consequences
2 Investigate the personal recovery capital PRC and social recovery capital SRC mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time eg PRC motivation self-efficacy coping SRC 12-step involvement social network changes
3 Investigate moderators of InTEGRAs effects on outcomes across one-year follow-up eg effect of age network support for AOD use psychiatric severity age composition of 12-step meetings on substance use and substance-related consequences It is hypothesized that higher network support for AOD use abstinence motivation and greater AOD severity will have a better response to InTEGRA
4 Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design
Detailed Description:
Interested individuals will be screened by phone followed by a more rigorous screening completed at intake With the anticipated sample size of 294 expected enrollment is between 6-7 participants per month across the two sites during the enrollment period about 3-4 per site
Participants are randomized to treatment conditions in a 11 ratio using a computerized urn randomization program stratified by age and gender The study data analyst will share this information with the treatment providers once a given group is ready to begin The research assistants conducting assessments will be blinded to condition assignment
Beginning at treatment conclusion approximately 3 months after enrollment participants are followed up every 3 months for one year following their baseline enrollment date
The treatment conditions are InTEGRA which integrates key elements of TSF with METCBT and METCBT alone
Participants are randomized to treatment conditions in a 11 ratio using a computerized urn randomization program stratified by age and gender The study data analyst will share this information with the treatment providers once a given group is ready to begin The research assistants conducting assessments will be blinded to condition assignment
Beginning at treatment conclusion approximately 3 months after enrollment participants are followed up every 3 months for one year following their baseline enrollment date
The treatment conditions are InTEGRA which integrates key elements of TSF with METCBT and METCBT alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA030926 | NIH | None | httpsreporternihgovquickSearchR01AA030926 |