Substance UseNCT07695818
Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse
A study testing Returning to the Land - Biodiverse Outdoor Setting in people with Substance Use and Children, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Substance Use, Children, Cultural Factors
- What is being tested?
- Returning to the Land - Biodiverse Outdoor Setting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Any condition preventing meaningful participation (e.g., lacking capacity to consent or planned relocation precluding attendance).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rocky Boy Health Center
Box Elder, Montana, 59521
Helen Russette, PhD, 406-262-4860, hrusset1@jhu.edu
About this study
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
- Being tested
- Returning to the Land - Biodiverse Outdoor Setting, Control
- Keywords
- substance use, Cultural practices, Effects on youth
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Returning to the Land - Biodiverse Outdoor SettingBehavioural
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
ControlBehavioural
The control condition is the Returning to the Land program that takes place in an indoor classroom setting
| Study group | Role | What they receive |
|---|---|---|
| Bio-diverse Outdoor Setting | Experimental | Returning to the Land - Bio-diverse Outdoor Setting Receives: Behavioral: Returning to the Land - Biodiverse Outdoor Setting |
| Control Group | Placebo comparator | Returning to the Land - Indoor Classroom Setting Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jun 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Helen Russette, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695818
- Sponsor's protocol ID
- IRB00035530
- Other IDs
- 1K01DA060294-01
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing and Evaluation of the Returning to the Land Intervention to Address and Prevent Substance Misuse
- ClinicalTrials.gov ID
- NCT07695818
- Acronym / sponsor ID
- IRB00035530
- Conditions
- Substance Use, Children, Cultural Factors
- Keywords
- substance use, Cultural practices, Effects on youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-diverse Outdoor Setting | Experimental | Behavioral: Returning to the Land - Biodiverse Outdoor SettingReturning to the Land - Bio-diverse Outdoor Setting |
| Control Group | Placebo comparator | Behavioral: ControlReturning to the Land - Indoor Classroom Setting |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Any condition preventing meaningful participation (e.g., lacking capacity to consent or planned relocation precluding attendance).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Returning to the Land - Biodiverse Outdoor SettingReturning 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 | Behavioural | Bio-diverse Outdoor Setting |
| ControlThe control condition is the Returning to the Land program that takes place in an indoor classroom setting | Behavioural | Control Group |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen Russette, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Returning to the Land - Biodiverse Outdoor Setting in people with Substance Use and Children, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Russette, PhD (406-262-4860, hrusset1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.