Clinical trial NCT04222556: Evaluation of Thiwáhe Gluwáš'Akapi Substance Use Prevention Program
Official title: Evaluation of an Optimized Intervention to Prevent Early Substance Use Among American Indian Youth: Examination of Expanded Impacts on Youth and Parents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Substance Abuse
Suicide
Keywords: American Indian
Adolescent
Parenting
Family
Prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-01-10
Enrollment: 552
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Researchers at the Centers for American Indian and Alaska Native Health in the Colorado School of Public Health at the University of Colorado completed an intensive community-engaged process to rigorously adapt the Strengthening Families Program for Parents and Youth 10-14 for the cultural context of a Northern Plains reservation community, creating a program optimized for American Indian families, Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong). This study will test the effectiveness of TG for delaying the onset of substance use among young adolescents. In response to requests from participating families and community partners to help address suicide risk among their youth, and based on preliminary evidence that the program may impact risk behaviors beyond substance use, the study will also test suicide risk outcomes among youth. Finally, in recognition of the potential for reciprocal influence on the adults participating in the program with their children, capitalizing on their motivation to make concomitant positive changes in their own lives, the current study will also examine effects on adult substance use. In summary, this study will test the effectiveness of TG for reducing risk for: (1) substance use among youth; (2) suicide risk among youth; and (3) substance abuse among adults.

Detailed description: Study design overview

All 13 middle schools on the reservation will participate in this study by providing space for program groups to meet in the evenings and allowing recruitment activities at school events. A total of 480 families will be recruited into 6 cohorts across two years (spring, summer and fall). In each community, families with a child 10-12 years of age will be recruited to participate in the study. Half of recruited families will be randomly assigned to receive the Thiwáhe Gluwáš'akapi (TG) substance use prevention program and half to the comparison group, which will receive the Woyute Waśte (WW) healthy eating and exercise program. Randomization will be explained to families as part of the recruitment and consent process. Given the potential for contamination across groups with this design, the investigators will carefully examine outcomes across groups and statistically control for contamination effects as necessary. Alternative designs, including randomization at the school/community level, were rejected due to greater concerns about cross-community variability.

Recruitment and retention strategies

Schools (e.g., registration, family nights, parent-teacher conferences, holiday events) will be the main points of recruitment but additional advertising and promotion will take place at community events such as powwows, health fairs, and basketball tournaments. Written materials about the program will be distributed, along with promotional items (e.g., water bottles, magnets, and lanyards with the project name and logo). The investigators will also advertise on local community radio, which has wide reach on the reservation. Because TG has been implemented at 12 of the 13 middle schools on the reservation as a part of the adaptation study and has been well received by both families and school staff, the investigators often have inquiries about opportunities for future participation, and anticipate a positive response to recruitment efforts.

Facilitators will call families weekly to touch base with them and remind them about upcoming sessions. The investigators provide meals to families at the start of each program session, giving them opportunities to connect with other families and facilitators, fostering relationships, and making it easier for busy families to get to the sessions. Child care and transportation will be provided, as needed.

Approaches to ensuring fidelity

All facilitators will be trained in TG by a master SFP 10-14 trainer from Iowa State University (Beth Fleming) and the master TG trainer (Dr. Alicia Mousseau, who led the program adaptation). Weekly supervision and preparation for sessions before and during implementation will be provided onsite by local staff certified as TG trainers, who will also train new facilitators as needed due to staff turnover. These on-site trainers will also conduct regular fidelity checks (observations during sessions using standardized fidelity checklists) and provide feedback to facilitators.

Data collection schedule and estimated sample sizes across waves

In each family, up to 2 eligible youth (aged 10-12) and 1 parent/caregiver will be eligible to participate in the research and take study surveys. Sample size estimates for each wave are estimates of the number of families (F), youth (Y), adults (A), and total sample (T). Ranges for youth and total reflect that 1-2 youth per family are eligible to complete surveys. Estimates include an attrition rate of 2.5% every 6 months, based on past experience with families in this community.

1. Baseline - 1-2 weeks before first session: F=480; Y=480-960; A=480; T=960-1440
2. Post-intervention -1 week after last session: F=480; Y=480-960; A=480; T=960-1440 6 follow-up surveys:
3. 6-month: F=468; Y=468-936; A=468; T=936-1404
4. 12-month: F=456; Y=456-912; A=456; T=912-1368
5. 18-month: F=445; Y=445-890; A=445; T=890-1335
6. 24-month: F=434; Y=434-868; A=434; T=868-1302
7. 30-month (excluding final cohort): F=370; Y=370-740; A=370; T=740-1110
8. 36-month (excluding final 2 cohorts): F=206; Y=206-412; A=206; T=412-618

Data collection procedures

All surveys will be administered online, using REDCap survey software. The baseline survey will be collected during an in-person meeting, after consent is obtained, using iPads provided by research staff. Post-intervention surveys will also be administered in person. For follow-up surveys, participants will be sent unique links to access their surveys on their own devices (e.g., computers, phones, tablets) or at a location of their choice (e.g., tribal college center). They will also be able to request to have research staff meet with them to collect these follow-up surveys in person and provide a project iPad for survey completion. Surveys collected via REDCap will be immediately uploaded to a secure cloud storage. REDCap is a secure, web-based application designed to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. REDCap is hosted by the University of Colorado Anschutz Medical Campus and supported by the Colorado Clinical and Translational Sciences Institute.

Analytic Plan

Three analytic approaches will be used: (1) discrete-time time survival analysis (DTSA), (2) mixed model analyses (MM), and (3) latent growth curve modeling (LGCM). Intention to treat principles will be applied in all analyses. Participant sex will be included as a covariate or separate models will be estimated by gender to explore differential effect patterns. Sandwich-estimators (type=complex in Mplus) and random effects models (in SAS Proc Mixed) will adjust for clustering at the family (and/or school) level. Full information maximum likelihood (FIML) procedures will be used to provide unbiased and efficient estimates.

Discrete-time survival analyses (DTSA) will be used to estimate the probability (hazard) for initiation of substance use among youth who have not used substances prior to enrollment in the study. Initial DTSA analyses will compare the fit of models assuming proportional odds (i.e., constant intervention effect across waves) either with or without frailty (residual variance) to non-proportional odds (i.e., variable intervention effect across waves). Comparisons will be based on the Akaike Information Criterion (AIC) and the Bayesian Information Criterion (BIC). Exposure to TG will be included as a time-invariant covariate to estimate treatment effects on risk of initiation. Mplus Monte Carlo analyses were used to determine power requirements for DTSA models. Effect-size estimates from earlier etiological work in this reservation community were used (hazard age 10-13, alcohol =.14; marijuana = .13, tobacco = .31). Estimated power to detect a moderate treatment effect - 20% reduction in risk of initiation - exceeded 80% across all effect-size specifications tested.

Mixed model analyses (MM) will be used to examine effects on all outcomes, including primary outcomes (youth substance use and suicide, adult substance use) and secondary outcomes (proximal mediators of risk for primary outcomes). MM analyses will account for correlated observations within participants over time and examine intervention effects averaged across the entire post-program data collection period and at each post-program assessment point individually. Wave of data collection and Condition (TG or WW) X Wave interaction will be fixed effects. Time will be a repeated measures factor and study participant and family cluster will be included as random effects. After verifying that randomization yielded baseline equivalence across Conditions, the investigators will use either linear (ordinal/continuous outcomes) or generalized linear mixed models (dichotomous outcomes) to test Condition X Wave interactions. The overall difference between TG and WW groups across the follow-up period compared to baseline will be obtained by calculating the average of all 7 Condition X Wave interaction effects. These analyses will test hypotheses about immediate and sustained effects of intervention exposures on outcomes. Power estimates for MM analyses were calculated using GLIMMPSE software, specifying estimates of substance use at each wave derived from previous work with this population. Analyses indicate that the projected sample size will be sufficient to detect a small to moderate intervention effect - 20% reduction in substance use across time - with power greater than .80.

The final analytic approach will follow Muthén \& Curran, estimating linear latent growth curve models (LGCM) to assess the effect of TG on outcome trajectories. The investigators will estimate the 'normative' trajectory of each outcome in the WW (comparison) group and the comparable trajectory in the TG (intervention) group. In the third step, the investigators will compare these trajectories and to determine whether there is a statistically significant change in the outcome trajectory related to TG intervention exposure. Finally, the investigators will evaluate the interaction between intervention exposure and initial level of the outcome to explore differential intervention effectiveness as a function of baseline levels for each outcome. Mplus Monte Carlo analyses were used to estimate power requirements for LGCM models and effect-size estimates were drawn from earlier etiological research. The power to detect slopes ranging from .14 to 1.4, were tested, estimating intercepts low (.05) consistent with our earlier findings and the young age of our study sample, setting alpha at .05, within each Condition group (TG treatment and WW comparison). Power estimates exceeded .90 to detect slope effects in all models.

Eligibility criteria: Inclusion Criteria:

* Youth participants:

  * 10-12 years old on the date of the first program session
  * Attending school on the reservation
  * Must enroll with an eligible adult
* Adult participants:

  * At least 18 years old
  * Must enroll with an eligible child
  * Must play a significant parenting role for the child enrolled in the study, as a parent, grandparent, other relative, legal guardian, or other household member.

Exclusion Criteria:

* Prisoners
* Decisionally-challenged adults

Primary outcomes:
measure: Lifetime alcohol use
timeFrame: Change from baseline to 36 months after intervention
measure: Alcohol initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of any alcohol use
timeFrame: Change from baseline to 36 months after intervention
measure: Past month frequency of consumption of 4+ (for females) or 5+ (for males) alcoholic drinks at one time
timeFrame: Change from baseline to 36 months after intervention
measure: Past month usual quantity of alcohol use [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime alcohol intoxication
timeFrame: Change from baseline to 36 months after intervention
measure: Alcohol intoxication initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of intoxication
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime use of cough syrup (without parental permission) [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Cough syrup use initiation (without parental permission) [youth only]
timeFrame: Up to 16 years of age
measure: Past month frequency of use of cough syrup without parental permission [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month quantity of use of cough syrup without parental permission [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime marijuana use
timeFrame: Change from baseline to 36 months after intervention
measure: Marijuana initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of marijuana use
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime cigarette use
timeFrame: Change from baseline to 36 months after intervention
measure: Cigarette initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of cigarette use
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime use of electronic vapor products
timeFrame: Change from baseline to 36 months after intervention
measure: Electronic vapor products initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of electronic vapor product use
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime chewing tobacco use
timeFrame: Change from baseline to 36 months after intervention
measure: Chewing tobacco initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of chewing tobacco use
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime inhalant use
timeFrame: Change from baseline to 36 months after intervention
measure: Inhalant use initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Past month frequency of inhalant use
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Prescription pain medicine use (non-medical) initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Lifetime frequency of prescription pain medicine use without a prescription or other than as prescribed [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month frequency of prescription pain medicine use without a prescription or other than as prescribed [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime cocaine use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Cocaine use initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Lifetime frequency of cocaine use [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month frequency of cocaine use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime methamphetamine use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Methamphetamine use initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Lifetime frequency of methamphetamine use [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month frequency of methamphetamine use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime heroin use [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Heroin use initiation
timeFrame: Up to 16 years of age for youth; up to 30 years for adults
measure: Lifetime frequency of heroin use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month frequency of heroin use [youth aged 13+ and adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Lifetime suicidal ideation [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past month suicidal ideation [youth only]
timeFrame: Change from baseline to 36 months after intervention
Secondary outcomes:
measure: Parent communication about alcohol and drugs [youth and adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parent rules about substance use [youth and adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Substance use attitudes [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Substance use norms [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Antisocial behavior [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Association with deviant peers [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Substance use resistance skills [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Substance use patterns (use of substances around children) [adults only]
timeFrame: Change from baseline to 36 months after intervention
measure: Children's Hope Scale [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Awareness of Connectedness scale (adapted) [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Past week depression [youth only]
timeFrame: Change from baseline to 36 months after intervention
measure: Family cohesion [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Family cohesion [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Family conflict [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Family conflict [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Family expressiveness [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Family expressiveness [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Use of family meetings [adult reports only]
timeFrame: Change from baseline to 36 months after intervention
measure: General parent-child communication [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: General parent-child communication [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parent warmth [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parent warmth [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parent negative affect [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parent negative affect [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental monitoring [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental structure/rule setting [adult reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental structure/rule setting [youth reports]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental support of autonomy [youth report only]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental use of discipline [adult report only]
timeFrame: Change from baseline to 36 months after intervention
measure: Parental anger management [adult report only]
timeFrame: Change from baseline to 36 months after intervention
measure: Support for parenting [adult report only]
timeFrame: Change from baseline to 36 months after intervention
measure: Parenting self-efficacy [adult report only]
timeFrame: Change from baseline to 36 months after intervention
Other outcomes:
measure: Daily fruit and vegetable consumption
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Weekly physical activity
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Daily water consumption
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Daily sugary drink consumption
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Depression [adults only]
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Life satisfaction [adults only]
timeFrame: Baseline, post-test (1 week post-intervention), follow-up at 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nancy R Whitesell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ivanich JD, Mousseau AC, Walls M, Whitbeck L, Whitesell NR. Pathways of Adaptation: Two Case Studies with One Evidence-Based Substance Use Prevention Program Tailored for Indigenous Youth. Prev Sci. 2020 Jan;21(Suppl 1):43-53. doi: 10.1007/s11121-018-0914-5.
citation: Whitesell NR, Mousseau AC, Keane EM, Asdigian NL, Tuitt N, Morse B, Zacher T, Dick R, Mitchell CM, Kaufman CE. Integrating Community-Engagement and a Multiphase Optimization Strategy Framework: Adapting Substance Use Prevention for American Indian Families. Prev Sci. 2019 Oct;20(7):1136-1146. doi: 10.1007/s11121-019-01036-y.