Health TrialsbyHealthPanel

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

ConditionsSubstance UseChildrenCultural Factors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorJohns Hopkins Bloomberg School of Public Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Bio-diverse Outdoor SettingExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 month, 6 month, 12 month
2

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.

Time frame
Baseline, 1 month, 6 month, 12 month
3

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.

Time frame
Baseline, 1 month, 6 month, 12 month
4

Caregiver alcohol use

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins Bloomberg School of Public Health

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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