Leveraging Evidence to Activate Parents (LEAP)

July 21, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parent Activation
This group of JPOs will deliver Parent Activation as a service to the juveniles and families on their caseloads.
Behavioral: Parent Activation
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.
Behavioral: Usual Services
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Social Learning Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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