Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse

Part of paid clinical trials in Box Elder, Montana.

Sponsor
Johns Hopkins Bloomberg School of Public Health
Study ID
NCT07695818
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 19 Years
Healthy Volunteers
Not accepted

Interventions

  • Returning to the Land - Biodiverse Outdoor Setting — BEHAVIORAL
    Returning to the Land is a land-based healing substance misuse intervention for young Native American caregivers and the caregiver's children. The intervention will take place in a bio-diverse outdoor setting
  • Control — BEHAVIORAL
    The control condition is the Returning to the Land program that takes place in an indoor classroom setting

Study Details

This study aims to test the Returning to the Land intervention in partnership with a tribal community. The program is designed to address caregiver substance use and child emotional and behavioral development.

Key Dates

First listed
Jul 10, 2026
Start date
Jun 15, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Bio-diverse Outdoor Setting
    Returning to the Land - Bio-diverse Outdoor Setting
  • Placebo Comparator: Control Group
    Returning to the Land - Indoor Classroom Setting

Primary Outcome Measure

Child social-emotional functioning as assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA) [ Time Frame: Baseline, 1 month, 6 month, 12 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rocky Boy Health CenterBox ElderMontana59521
Helen Russette, PhD
406-262-4860

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