- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779229
Leveraging Evidence to Activate Parents (LEAP)
January 9, 2024 updated by: Mike McCart, Oregon Social Learning Center
Linking a Pediatric Healthcare Advance With a Task-Shifting Approach to Optimize Juvenile Justice Outcomes
The juvenile justice (JJ) system serves over a million cases every year and represents the primary referral source for treatment of substance use and antisocial behavior in youth.
However, engagement of the JJ population in treatment is alarmingly low; further, rural communities have neither access to evidence-based practices (EBPs) nor the finances and treatment infrastructure to support their delivery.
However, using an innovation called task-shifting, juvenile probation/parole officers in rural communities might be able to deliver a central change mechanism for EBPs (parent activation), with the ultimate goal of improving JJ youth outcomes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Juvenile justice (JJ) is the public service system most impacted by alcohol and other drug (AOD) use in youth, and outcomes for these youth, their families, and society are grave.
Thus, delivery of effective interventions with JJ youth is of considerable importance.
The evidence-based practices (EBPs) with the strongest outcomes for JJ youth are family-based, but many communities do not have the resources to support their delivery.
This is particularly true in rural areas where AOD treatment resources are scarce.
Further, even when communities can support a family-based EBP, JJ youth face barriers to treatment participation.
Indeed, JJ youth are routinely referred for treatment, but data indicate less than 1 in 5 actually receive treatment.
Juvenile probation/parole officers (JPOs) are on the front line of this crisis.
This workforce is in every community across the nation and routinely interfaces with JJ youth to try to achieve positive outcomes.
However, JPOs often face limited options for treatment referrals; further, they do not have the time or training to deliver one of the full-scale, family-based EBPs.
As a consequence, JPOs try to manage the behavior of their probationers with a small menu of youth-based interventions that have limited success (e.g., structured sanctions).
One strategy for achieving better outcomes in low-resourced, rural settings that cannot deploy a full-scale EBP, called task-shifting, involves redistribution of tasks downstream to an indigenous workforce that has less training.
Importantly, reviews indicate that the leading EBPs for JJ youth share a common change mechanism: activation of parents.
Thus, while the family-based EBPs cannot be task-shifted, perhaps the central change mechanism of these EBPs (parent activation) can be shifted downstream to enhance JPO practice.
JJ leaders already cite improved parent engagement as a top priority, but it is also one of the most challenging problems facing the JJ system.
Fortuitously, within pediatric healthcare services, there is an effective intervention called parent activation (PA) comprised of concrete tasks by healthcare service providers to better engage and motivate parents of at-risk youth.
PA has been delivered by clinicians and also by paraprofessionals.
Thus, this healthcare service advance might be primed for use by JPOs to activate parents and achieve more positive JJ youth outcomes.
The proposed stepped-wedge cluster randomized trial investigates the use and impact of PA by JPOs across 32+ rural counties.
Aims are to: (1) determine the capacity of JPOs to deliver PA within JJ services, (2) examine impact of PA delivery on de-identified family outcomes, and (3) examine implementation outcomes, assessed via the Stages of Implementation Completion, for PA in the JJ service system, including JPO inner context variables that might impact implementation.
In a context where the nation's behavioral healthcare service system is struggling to meet the needs of JJ youth, JPOs across the nation, and particularly in rural communities, are positioned to make a large impact via use of an advance from pediatric healthcare services.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Oregon Social Learning Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Any juvenile probation/parole officer working in a participating county in Idaho or Oregon who consents to participate.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Parent Activation
This group of JPOs will deliver Parent Activation as a service to the juveniles and families on their caseloads.
|
Parent Activation (PA) is comprised of concrete social learning theory steps (i.e., direct instruction, modeling, practice opportunities, and reinforcement) that aim to enhance a parent's confidence, knowledge, and ability to manage his/her child's health.
PA is applicable across a range of conditions, including behavioral and psychiatric problems, and it can be delivered by varied providers, including paraprofessionals.
|
Active Comparator: Usual Services
This group of JPOs will deliver services as usual to the juveniles and families on their caseloads.
|
This intervention refers to the typical techniques that JPOs employ to monitor the juveniles on their caseloads (e.g., regular meetings with youth and parents to ensure the youth is following conditions of probation and issuing swift sanctions [community service; detention] if conditions are not being followed).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from Baseline scores compared to 36 months post-Baseline on fidelity to Parent Activation (measured at Baseline, End of Usual Services phase, every 3 months for 9 months, and then every 6 months until 36 months post-Baseline).
Time Frame: Baseline to 36 months
|
Fidelity to Parent Activation techniques by JPOs as measured using Standardized Patient Assessments (Observational coding of video recordings with trained actors).
|
Baseline to 36 months
|
Changes in number and severity of criminal charges in de-identified youth records from Baseline compared with 36 months post-Baseline.
Time Frame: Baseline to 36 months
|
The number and severity of criminal charges measured by de-identified archival arrest records obtained from Idaho and Oregon state justice databases.
|
Baseline to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from Baseline in attitudes towards Evidence-Based practices compared to 36 months post-Baseline (measured at 0, 6, 12, 18, 24, 30, and 36 months).
Time Frame: Baseline to 36 months
|
Ratings on attitudes towards evidence-based practices as measured by the Evidence-Based Practice Attitude Scale (Self-report completed by the JPOs).
|
Baseline to 36 months
|
Changes from Baseline in perceived burnout compared to 36 months post-Baseline (measured at 0, 6, 12, 18, 24, 30, and 36 months).
Time Frame: Baseline to 36 months
|
Ratings on perceived levels of burnout as measured by the Maslach Burnout Inventory - Human Services Survey (Self-report completed by the JPOs).
|
Baseline to 36 months
|
Changes from Baseline in perceived agency support of evidence-based practices implementation compared to 36 months post-Baseline (measured at 0, 6, 12, 18, 24, 30, and 36 months).
Time Frame: Baseline to 36 months
|
Ratings on perceived agency/county level of support for the implementation of evidence-based practices as measured by the Implementation Climate Survey (Self-report completed by the JPOs).
|
Baseline to 36 months
|
Changes from Baseline in perceived processes and outcomes between JPOs and the researchers compared to 36 months post-Baseline (measured at 0, 6, 12, 18, 24, 30, and 36 months).
Time Frame: Baseline to 36 months
|
Ratings on perceived processes and outputs between the JPOs and the researchers as measured by the Cultural Exchange Inventory (Self-report completed by the JPOs).
|
Baseline to 36 months
|
Changes from Baseline in de-identified family outcomes (parent attendance and the number of positive youth drug screens) compared to 36 months post-Baseline (measured biweekly for 36 months).
Time Frame: Baseline to 36 months
|
De-identified family outcomes (parent attendance and youth drug screen results) at JPO appointments as measured by the Intensive Longitudinal Data Collection Survey created by the researchers (Self-report completed by the JPOs and separately, de-identified parents).
|
Baseline to 36 months
|
Stage of Implementation reached by 36 months post-Baseline (measured biweekly for 36 months).
Time Frame: Baseline to 36 months
|
Dates of implementation milestones of Parent Activation in a county as measured by the Stages of Implementation Completion (Observational codes completed by the researchers).
|
Baseline to 36 months
|
Changes from Baseline in perceived parent self-efficacy compared to 36 months post-Baseline (measured biweekly for 36 months).
Time Frame: Baseline to 36 months
|
Ratings on perceived self-efficacy in parenting measured by the Parent Self-Agency Measure (Self-report completed by de-identified parents attending juvenile probation appointments).
|
Baseline to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael McCart, Ph.D., Oregon Social Learning Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
February 26, 2021
First Submitted That Met QC Criteria
February 26, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
January 11, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA050669 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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