Menu
Recruiting NCT07695818

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

No phase Interventional Substance Use Children Cultural Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Returning to the Land - Biodiverse Outdoor Setting, Control.
Who it may be relevant to
Registry conditions: Substance Use, Children, Cultural Factors. Basic parameters: 14 years — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral Control
    The control condition is the Returning to the Land program that takes place in an indoor classroom setting

Primary outcome measures

  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Rocky Boy Health Center — Box Elder

Identifiers

NCT: NCT07695818 · IRB00035530 · 1K01DA060294-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗