Recruiting

Returning to the Land

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT07695818

Conditions

Substance Use

Children

Cultural Factors

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Interventions

Returning to the Land - Biodiverse Outdoor Setting

Control

Study Details

Brief summary:

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.

Conditions

Substance Use

Children

Cultural Factors

Study ID

NCT07695818

Start date

Jun 15, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Reside on or near the Rocky Boy Reservation (\~50-mile round trip);
  • Aged 14-19 years;
  • Parent or primary caregiver to at least one child who will be age 1-5 years at the start of the intervention.

Exclusion Criteria:

  • Any condition preventing meaningful participation (e.g., lacking capacity to consent or planned relocation precluding attendance).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

Returning to the Land - Biodiverse Outdoor Setting

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

The control condition is the Returning to the Land program that takes place in an 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 ]
  • Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL 11/2-5) [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL/6-18) [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Caregiver alcohol use [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Caregiver cannabis use [ Time Frame: Baseline, 1 month, 6 month, 12 month ]
  • Caregiver non-prescribed pain medicine use [ Time Frame: Baseline, 1 month, 6 month, 12 month ]

Central Contacts and Locations

Central contacts

Helen Russette, PhD

406-262-4860hrusset1@jhu.edu

Locations

Rocky Boy Health Center

Recruiting

Box Elder, Montana, United States, 59521

Contacts

Helen Russette, PhD

406-262-4860hrusset1@jhu.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • substance use
  • Cultural practices
  • Effects on youth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-08-05.