NCT07695818

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Apr 2029

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Substance UseChildrenCultural Factors

Keywords

substance useCultural practicesEffects on youth

Outcome Measures

Primary Outcomes (6)

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

    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.

    Baseline, 1 month, 6 month, 12 month

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

    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.

    Baseline, 1 month, 6 month, 12 month

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

    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.

    Baseline, 1 month, 6 month, 12 month

  • Caregiver alcohol use

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

    Baseline, 1 month, 6 month, 12 month

  • Caregiver cannabis use

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

    Baseline, 1 month, 6 month, 12 month

  • Caregiver non-prescribed pain medicine use

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

    Baseline, 1 month, 6 month, 12 month

Study Arms (2)

Bio-diverse Outdoor Setting

EXPERIMENTAL

Returning to the Land - Bio-diverse Outdoor Setting

Behavioral: Returning to the Land - Biodiverse Outdoor Setting

Control Group

PLACEBO COMPARATOR

Returning to the Land - Indoor Classroom Setting

Behavioral: Control

Interventions

Returning to the Land - Biodiverse Outdoor SettingBEHAVIORAL

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

Bio-diverse Outdoor Setting
ControlBEHAVIORAL

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

Control Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Helen Russette, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Russette, PhD

CONTACT

406-262-4860hrusset1@jhu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share