Trial Outcomes & Findings for Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY) (NCT NCT02290938)

NCT ID: NCT02290938

Last Updated: 2024-06-26

Results Overview

For this study, we created a dichotomous indicator of whether adolescents reported any use of alcohol. This is because alcohol use rates are typically lower in younger adolescents, leading to highly skewed distributions in continuous variables.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 185 participants
• Primary outcome timeframe: change from baseline to 6 months
• Results posted on: 2024-06-26

Participant Flow

Given the importance to our partnering Native communities that every teen receive some culturally relevant intervention, our "control" group was not the standard control that is often seen in RCTs. Our control group comprised a large cultural event (Community Wellness Gathering or CWG) designed to connect adolescents with their heritage and AI/AN resources in their community. The intervention group received the CWG + MICUNAY.

Participant milestones

Measure	Community Wellness Gatherings All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Overall Study STARTED	70	115
Overall Study COMPLETED	56	72
Overall Study NOT COMPLETED	14	43

Reasons for withdrawal

Measure	Community Wellness Gatherings All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Overall Study Lost to Follow-up	14	43

Baseline Characteristics

Motivational Interviewing and Culture for Urban Native American Youth (MICUNAY)

Baseline characteristics by cohort

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.	Total n=185 Participants Total of all reporting groups
Age, Continuous	15.51 years STANDARD_DEVIATION 1.18 • n=5 Participants	15.66 years STANDARD_DEVIATION 1.41 • n=7 Participants	15.61 years STANDARD_DEVIATION 1.33 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	68 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	55 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	60 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	39 Participants n=5 Participants	70 Participants n=7 Participants	109 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Minimum of Graduated from High School (mother)	49 Participants n=5 Participants	71 Participants n=7 Participants	120 Participants n=5 Participants
Minimum of Graduated from High School (father)	39 Participants n=5 Participants	55 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

For this study, we created a dichotomous indicator of whether adolescents reported any use of alcohol. This is because alcohol use rates are typically lower in younger adolescents, leading to highly skewed distributions in continuous variables.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Number of Participants Who Used Alcohol From Baseline to 6 Months	22 Participants	33 Participants

PRIMARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

For this study, we created a dichotomous indicator of whether adolescents reported any use of marijuana. This is because marijuana use rates are typically lower in younger adolescents, leading to highly skewed distributions in continuous variables.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Number of Participants Who Used Marijuana From Baseline to 6 Months	22 Participants	32 Participants

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Adolescents reported on the alcohol consequences they had experienced in past three months. Consequences are based on DSM-IV criteria with 7 items for alcohol (e.g., missed school or work). For this analysis we created dichotomous indicators of whether adolescents reported any consequences from alcohol.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Number of Participants Who Reported Consequences of Alcohol Use	23 Participants	37 Participants

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Adolescents reported on the marijuana consequences they had experienced in past three months. Consequences are based on DSM-IV criteria with 5 items for marijuana (e.g., had difficulty concentrating). For this analysis we created dichotomous indicators of whether adolescents reported any consequences from marijuana.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Number of Participants Who Reported Consequences of Marijuana Use	23 Participants	35 Participants

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Intentions to Use - Alcohol	1.84 score on a scale Standard Deviation 1.04	1.65 score on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Intentions to Use - Cigarettes	1.77 score on a scale Standard Deviation 1.23	1.66 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed whether adolescents believed they would drink any alcohol, use any marijuana, or smoke a cigarette in the next six months (1="definitely yes" to 4="definitely no").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Intentions to Use - Marijuana	2.03 score on a scale Standard Deviation 1.14	1.92 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Alcohol resistance self-efficacy (RSE) for alcohol was defined as the average of four items rated from "I would definitely use" to "I would definitely not use" based on different situations (e.g., if my best friend were using; you were bored at party; your friend gives you a drink). RSE ranged from 1 to 4; higher scores indicated greater RSE.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Alcohol Resistance Self-efficacy	3.00 score on a scale Standard Deviation 1.06	2.95 score on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Peer Influence - Alcohol	1.76 score on a scale Standard Deviation 0.94	1.76 score on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Peer Influence - Marijuana	2.14 score on a scale Standard Deviation 1.18	2.04 score on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Three separate items assessed how often adolescents spend time around teens who drink, use marijuana, or smoke cigarettes (1 = "never" to 4 = "often").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Peer Influence - Cigarettes	1.53 score on a scale Standard Deviation 0.93	1.54 score on a scale Standard Deviation 0.83

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Adolescents reported how likely they were to participate in >20 different traditional practices (e.g., going to Pow Wows, prayer, playing Native hand or stick games) in the next six months (1="definitely yes" to 4="definitely no").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Intentions to Participate in Traditional Practices	2.71 score on a scale Standard Deviation 0.96	2.68 score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

We assessed adolescents' AI/AN cultural pride and sense of belonging with the Multigroup Ethnic Identity Measure (MEIM), which has twelve items. Respondents are asked the degree to which they agree with statements such as, "I have a clear sense of my ethnic background and what it means to me" on a scale from 1 = "strongly disagree" to 5 = "strongly agree". Given that our prior focus group work indicated that many adolescents were of mixed ethnicity, and our focus was on AI/AN identity, we modified these items to focus on AI/AN heritage (e.g., "I have clear sense of my AI/AN identity and what it means to me").

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Cultural Identification	3.11 score on a scale Standard Deviation 1.13	3.39 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: change from baseline to 6 months

Population: American Indian/Alaska Native adolescents aged 14-18.

Spirituality and happiness were measured using a subset of ten items from the 12-item Functional Assessment of Chronic Illness Therapy-Fatigue-Spiritual Questions instrument, or FACIT-SP 12. Adolescents reported agreement with statements such as "I find comfort in my faith or spiritual beliefs" and "I feel a sense of harmony within myself." Two items that referred specifically to chronic illness were removed from the scale as they were not relevant for this study. Response options, which ranged from 1="not at all" to 5="very much," were averaged, with negative statements reversed such that higher scores indicated greater spirituality and happiness.

Outcome measures

Measure	Community Wellness Gatherings n=70 Participants All youth will attend a CWG, which is a monthly gathering focused on making healthy choices and learning about Native American culture Community Wellness Gathering: a monthly gathering focused on making healthy choices and learning about Native American culture	Community Wellness Gathering + MICUNAY n=115 Participants Some participants randomized to MICUNAY, a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity. MICUNAY: MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
Change in Spirituality/Happiness	3.12 score on a scale Standard Deviation 1.24	3.29 score on a scale Standard Deviation 1.29

Adverse Events

Community Wellness Gatherings

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Community Wellness Gathering + MICUNAY

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth D'Amico

RAND

Phone: 310-393-0411

Email: damico@rand.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place