Substance UseLEAPNCT04779229
Leveraging Evidence to Activate Parents
A study testing Parent Activation and Usual Services in people with Substance Use, run by Oregon Social Learning Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Parent Activation and Usual Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 20 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any juvenile probation/parole officer working in a participating county in Idaho or Oregon who consents to participate.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Parent Activation, Usual Services
- Keywords
- Substance Use, Delinquency, Parents, Adolescents
- 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.
Parent ActivationBehavioural
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.
Usual ServicesBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Parent Activation | Experimental | This group of JPOs will deliver Parent Activation as a service to the juveniles and families on their caseloads. Receives: Behavioral: Parent Activation |
| Usual Services | Active comparator | This group of JPOs will deliver services as usual to the juveniles and families on their caseloads. Receives: Behavioral: Usual Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Fidelity to Parent Activation techniques by JPOs as measured using Standardized Patient Assessments (Observational coding of video recordings with trained actors).
Measured: 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.
The number and severity of criminal charges measured by de-identified archival arrest records obtained from Idaho and Oregon state justice databases.
Measured: Baseline to 36 months
Secondary outcomes (7)
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).
Ratings on attitudes towards evidence-based practices as measured by the Evidence-Based Practice Attitude Scale (Self-report completed by the JPOs).
Measured: 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).
Ratings on perceived levels of burnout as measured by the Maslach Burnout Inventory - Human Services Survey (Self-report completed by the JPOs).
Measured: 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).
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).
Measured: 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).
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).
Measured: 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).
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).
Measured: Baseline to 36 months
Stage of Implementation reached by 36 months post-Baseline (measured biweekly for 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).
Measured: Baseline to 36 months
Changes from Baseline in perceived parent self-efficacy compared to 36 months post-Baseline (measured biweekly for 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).
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Mar 2021
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Social Learning Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mike McCart, Oregon Social Learning Center
- Investigators
- Michael McCart, Ph.D., Principal investigator, Oregon Social Learning Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779229
- Sponsor's protocol ID
- R01DA050669
- Acronym
- LEAP
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2021
- Last updated
- 25 Sep 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking a Pediatric Healthcare Advance With a Task-Shifting Approach to Optimize Juvenile Justice Outcomes
- ClinicalTrials.gov ID
- NCT04779229
- Acronym / sponsor ID
- LEAP / R01DA050669
- Conditions
- Substance Use
- Keywords
- Substance Use, Delinquency, Parents, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Oregon Social Learning CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 3 Mar 2021 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent Activation | Experimental | Behavioral: Parent ActivationThis group of JPOs will deliver Parent Activation as a service to the juveniles and families on their caseloads. |
| Usual Services | Active comparator | Behavioral: Usual ServicesThis group of JPOs will deliver services as usual to the juveniles and families on their caseloads. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any juvenile probation/parole officer working in a participating county in Idaho or Oregon who consents to participate.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Parent ActivationParent 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. | Behavioural | Parent Activation |
| Usual ServicesThis 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). | Behavioural | Usual Services |
Primary outcome
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).
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.
7 secondary outcomes
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
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
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
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
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
Stage of Implementation reached by 36 months post-Baseline (measured biweekly for 36 months).
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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. This study is not recruiting at the moment.
Michael McCart, Ph.D. principal investigator
Oregon Social Learning Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Activation and Usual Services in people with Substance Use, run by Oregon Social Learning Center 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 1 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: finished, as of the sponsor's last update on 25 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 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 25 Sep 2026.