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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07695818

Enrollment

Registered

2026-07-10

Start date

2026-06-15

Completion date

2029-04-01

Last updated

2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Cultural Factors, Substance Use

Keywords

substance use, Cultural practices, Effects on youth

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.

Interventions

BEHAVIORALReturning 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

BEHAVIORALControl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 19 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Child social-emotional functioning as assessed by the Brief Infant Toddler Social Emotional Assessment (BITSEA)	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.
Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL 11/2-5)	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.
Child social-emotional functioning as assessed by the Child Behavior Checklist (CBCL/6-18)	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.
Caregiver alcohol use	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.
Caregiver cannabis use	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.
Caregiver non-prescribed pain medicine use	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.

Countries

United States

Contacts

CONTACTHelen Russette, PhD

hrusset1@jhu.edu406-262-4860

PRINCIPAL_INVESTIGATORHelen Russette, PhD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026