NCT03947177

Brief Summary

The purpose of this study is to compare two versions of an intervention focused on teaching 10-14-year-old Latina/o adolescent's skills that will decrease the likelihood that they will use tobacco, alcohol, and other drugs. We are also interested in determining how cultural context is related to substance use and whether additional information about other tobacco products should be added to the GMIT intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

May 9, 2019

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (13)

  • Change in tobacco use intentions

    4-item self-reported tobacco use scale. Each item is scored from 1 (definitely yes) to 4 (definitely no) yielding a range between 4 and 16

    Baseline to 3 months

  • Change in tobacco use attitudes

    7-item self-reported attitudes about tobacco scale. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 7 and 28

    Baseline to 3 months

  • Change in smoking refusal intentions

    7 item self-reported smoking refusal intentions scale. Each item is scored from 1 (Definitely would say "No") to 5 (Definitely would not say "No") yielding a range from 7 to 35

    Baseline to 3 months

  • Change in marijuana or other drug refusal intentions

    5-item self-reported marijuana or other drug refusal intentions scale. Each item is scored from 1 (Definitely would) to 5 (Definitely would not) yielding a range from 5 to 25.

    Baseline to 3 months

  • Change in parent-child communication about tobacco

    6-item self-reported antismoking socialization scale. Item scores vary depending on response type (Yes/no or Likert scale). Total scores range from 0 to 9

    Baseline to 3 months

  • Change in parental monitoring - adolescent

    24-item self-reported parenting practices scale completed by adolescents. Each item is scored from 1 (high monitoring) to 5 (low monitoring) yielding a range from 24 to 120

    Baseline to 3 months

  • Change in parental monitoring - parent

    24-item self-reported parenting practices scale completed by parents. Each item is scored from 1 (high monitoring) to 5 (low monitoring) yielding a range from 24 to 120

    Baseline to 3 months

  • Change in parent-child conflict - adolescent

    3-item conflict scale completed by adolescents. Each item is scored 1 (Never or Hardly at all) to 5 (Always or Extremely much) yielding scores ranging from 3 to 15

    Baseline to 3 months

  • Change in parent-child conflict - parent

    20-item conflict scale completed by parents. Each item is scored 0 (False) or 1 (True) yielding scores ranging from 0 to 20

    Baseline to 3 months

  • Change in family cohesiveness - adolescent

    10-item Family Adaptability and Cohesion Evaluation Scale completed by adolescents. Each item is scored from 1 (almost never) to 5 (almost always) yielding a range from 10 to 50.

    Baseline to 3 months

  • Change in family cohesiveness - parent

    10-item Family Adaptability and Cohesion Evaluation Scale completed by parents. Each item is scored from 1 (almost never) to 5 (almost always) yielding a range from 10 to 50.

    Baseline to 3 months

  • Change in parent-child communication - adolescent

    20-item Parent-Adolescent Communication Scale completed by adolescents. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 20 and 100.

    Baseline to 3 months

  • Change in parent-child communication - parent

    20-item Parent-Adolescent Communication Scale completed by parents. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 20 and 100.

    Baseline to 3 months

Secondary Outcomes (1)

  • Program feasibility

    Baseline to 6 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

GMIT

Behavioral: GMIT

Intervention

EXPERIMENTAL

Modified GMIT + Parenting support groups

Behavioral: GMIT+

Interventions

GMIT+BEHAVIORAL

Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices. Parents and/or guardians will virtually participate in parent-only support group sessions.

Intervention

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents must be between 10 and 16 years of age - parents can be any age
  • Parent and adolescent must consent/assent to participate as dyad
  • Self-identify as Latina/o or Hispanic

You may not qualify if:

  • Under the age of 10 or over the age of 16
  • Parent or adolescent refuses
  • Identify as non-Latina/o or non-Hispanic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Underage DrinkingSmoking, Non-Tobacco Products

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorAlcohol DrinkingDrinking BehaviorSmoking

Study Officials

  • Rosalie Corona, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

September 9, 2019

Primary Completion

September 21, 2021

Study Completion

September 21, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations