Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07695818

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Substance Use Chemically-Induced Disorders Children Cultural Factors Mental Disorders Substance-Related Disorders

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Primary outcomes

  1. Child social-emotional functioning as assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA)

    Time frame: Baseline, 1 month, 6 month, 12 month

    Caregivers will complete the Brief Infant Toddler Social Emotional Assessment (BITSEA) for children ages 12-18 months. The total BITSEA Problems Score is the sum of responses, score range from 0-62. Higher scores indicate poorer functioning.

  2. Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL 11/2-5)

    Time frame: Baseline, 1 month, 6 month, 12 month

    Caregivers will complete the Child Behavior Checklist (CBCL/1½-5) for children ages 18 months-5 years. Minimum score is 0, maximum score is 72. Higher scores indicates more of the behaviors.

  3. Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL/6-18)

    Time frame: Baseline, 1 month, 6 month, 12 month

    Caregivers will complete the Child Behavior Checklist (CBCL/6-18) for children who turn age 6 or older. Minimum score is 0, maximum score is 72. Higher scores indicates more of the behaviors.

  4. Caregiver alcohol use

    Time frame: Baseline, 1 month, 6 month, 12 month

    Measured using the Q-F substances & screens. Scores rang from 0 to 450, with higher score indicating more drinks per day.

  5. Caregiver cannabis use

    Time frame: Baseline, 1 month, 6 month, 12 month

    Measured using the Q-F substances & screens. Scores rang from 0 to 150, with higher score indicating more cannabis per day.

  6. Caregiver non-prescribed pain medicine use

    Time frame: Baseline, 1 month, 6 month, 12 month

    Measured using the Q-F substances & screens. Scores rang from 0 to 11, with higher score indicating more non-prescribed pain medication per day.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Russette, PhD

CONTACT

[email protected]

406-262-4860

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.