Substance Use DisordersNCT07044531
DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM
A study testing Training-as-Usual (TAU), TDPP-A (Asynchronous Platform) and TDPP-Z (Hybrid) in people with Substance Use Disorders and Alcohol Use Disorders, run by Thrive Digital Health, LLC at 1 site in United States.
Trial summary
This study tests an online training platform for peer recovery support specialists, people in recovery who support others with alcohol and other substance use problems. It compares the platform with standard live training on core peer recovery skills, rated by trained raters from a recorded interview, and on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Alcohol Use Disorders, Recovery Support Services
- What is being tested?
- Training-as-Usual (TAU), TDPP-A (Asynchronous Platform) and TDPP-Z (Hybrid)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2025to Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Eligible participants will be prospective PRSS providers residing in the U.S., ages 18 and over, with at least one year of continuous sobriety.
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Exclusion Criteria: We will exclude individuals with eligibility questionnaire responses indicating: (a) an inability to read or speak English; (b) active suicidal ideation (PHQ-9, Item 9); (c) severe anxiety (GAD-7 >15); (d) significant medical illnesses, and; (e) unable to complete the baseline assessment or unavailable for computer and telephone follow-ups over the approximately ten month study period.
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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
Thrive Digital Health
Solon, Ohio, 44139
Christopher Pesce, JD/MBA, 617-784-8715, cpesce@thrivedigitalhealth.us
About this study
Official title: DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE
This study tests an online training platform for peer recovery support specialists, people in recovery who support others with alcohol and other substance use problems. It compares the platform with standard live training on core peer recovery skills, rated by trained raters from a recorded interview, and on knowledge, usability, and intention to use the platform. Training conditions were first recruited separately. Since an IRB-approved change in August 2026, new participants are randomly assigned to either hybrid platform training or standard live training. A self-paced platform group and a Maryland group that used a version of the platform localized for that state are reported as non-randomized comparison groups. The study is Phase II of an SBIR Fast-Track award from the National Institute on Alcohol Abuse and Alcoholism.
Read the detailed description
Peer recovery support specialists (PRSS) are people with lived experience of recovery who provide non-clinical support to others with alcohol and other substance use disorders. This study evaluates the Thrive Digital Peer Platform (TDPP), an online training platform for PRSS. It is Phase II of an SBIR Fast-Track award from the National Institute on Alcohol Abuse and Alcoholism (R44AA030953). The Phase I pilot is registered separately as NCT07090590.
Training conditions. (1) Training as usual (TAU): the standard live, instructor-led CCAR course. (2) TDPP-A: the self-paced platform modules only. (3) TDPP-Z (hybrid): the self-paced modules plus an interactive roleplay practice component and recorded instructor video. (4) Maryland localization cohort (Aim 3): the self-paced content localized for a second state, delivered to prospective PRSS in Maryland in June and July 2026.
Allocation. The study was designed as a randomized trial. Randomized assignment was not feasible in practice, and enrollment from May 2025 through August 2026 proceeded by condition, with recruitment conducted separately for each condition. Under a protocol amendment approved by the IRB on August 21, 2026, all remaining participants are assigned at the point of consent by simple individual-level randomization, with equal allocation, to TDPP-Z or TAU. The assignment is generated automatically by the study system and logged, and outreach staff are blinded to upcoming assignments. Recruitment into TDPP-A is complete. TDPP-A and the Maryland cohort were recruited as groups and are non-randomized comparison groups. The statistical analysis plan, to be finalized before database lock, will specify how participants enrolled before the amendment are handled alongside randomized participants. The first three participants to complete the hybrid condition were pilot participants used to establish that condition's procedures.
Change to the hybrid condition. The original hybrid condition included three live videoconference sessions. They were removed in August 2026 because participants did not reliably attend them, and the condition now uses recorded instructor video and interactive roleplay practice with the same core content.
Outcomes. The primary outcome is skill and adherence on a recorded post-training behavioral interview, scored by trained raters blinded to condition using a modified Yale Adherence and Competence Scale II (YACS-II). Secondary outcomes are knowledge before and after training, usability (System Usability Scale), and intention to use the platform (modified UTAUT-2). Satisfaction and exit-interview feedback are also collected.
- Conditions
- Substance Use Disorders, Alcohol Use Disorders, Recovery Support Services, Peer Recovery Coaching
- Being tested
- Training-as-Usual (TAU), TDPP-A (Asynchronous Platform), TDPP-Z (Hybrid), Localized TDPP (Maryland)
- Keywords
- Peer Recovery Support Services, Peer Recovery Coaching, Alcohol Use Disorders, Substance Use Disorders
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training-as-Usual (TAU)Behavioural
Standard live, instructor-led training course from the Connecticut Community for Addiction Recovery (CCAR), with no digital platform modules.
TDPP-A (Asynchronous Platform)Behavioural
Participants engage with the Thrive Digital Peer Platform (TDPP), a fully asynchronous, self-paced online training program. The content includes 11 interactive modules structured using the Connect → Grow → Apply (CGA) learning framework, featuring peer stories, behavioral exercises, and scenario-based assessments.
TDPP-Z (Hybrid)Behavioural
The self-paced TDPP modules plus an interactive roleplay practice component and recorded instructor video. This replaced three live, facilitator-led videoconference sessions in August 2026.
Localized TDPP (Maryland)Behavioural
The self-paced TDPP content localized for Maryland peer recovery support specialists.
| Study group | Role | What they receive |
|---|---|---|
| Training as Usual | Active comparator | Participants complete the standard live, instructor-led Connecticut Community for Addiction Recovery (CCAR) training course. There are no digital platform modules. Participants enrolled before August 21, 2026 were recruited directly into this condition. From that date, participants are assigned to this condition by randomization, 1:1 with TDPP-Z. Receives: Behavioral: Training-as-Usual (TAU) |
| TDPP-A (Asynchronous Only) | Experimental | Participants complete the Thrive Digital Peer Platform (TDPP) in a fully self-paced format: 11 interactive modules using the Connect, Grow, Apply model, with peer-led stories and scenario-based exercises. There is no live facilitation. Participants were recruited directly into this condition from May to July 2025. Recruitment is complete. This is a non-randomized comparison group. Receives: Behavioral: TDPP-A (Asynchronous Platform) |
| TDPP-Z (Hybrid) | Experimental | Participants complete the self-paced TDPP modules plus an interactive roleplay practice component and recorded instructor video. The three live videoconference sessions in the original design were removed in August 2026. Participants enrolled before August 21, 2026 were recruited directly into this condition, and the first three completers were pilot participants. From that date, participants are assigned to this condition by randomization, 1:1 with TAU. Receives: Behavioral: TDPP-Z (Hybrid) |
| Maryland Localization Cohort (Aim 3) | Experimental | Prospective peer recovery support specialists in Maryland complete the self-paced TDPP content localized for Maryland, with the same assessments as the other conditions, in June and July 2026 (Aim 3). Recruited as a single group. This is a descriptive, non-randomized comparison cohort. Receives: Behavioral: Localized TDPP (Maryland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill and Adherence Score, Modified Yale Adherence and Competence Scale II (YACS-II)
Recorded post-training behavioral interview using standardized peer recovery scenarios, scored by two trained raters blinded to training condition using the Yale Adherence and Competence Scale II modified for peer recovery support. Adherence (frequency and extensiveness) and skill level are each rated from 1 to 7, and the raters' scores are averaged. Higher scores mean better adherence and skill.
Measured: Post-intervention (within 2 weeks of training completion)
Secondary outcomes (3)
System Usability Scale (SUS) Score
Self-reported usability on the 10-item System Usability Scale, scored by the standard method on a 0 to 100 scale. Higher scores mean better usability. Completed by participants in the platform conditions.
Measured: Immediately post-training
Knowledge Test Score, Change From Baseline
10-item multiple-choice test on core principles of professionalism in peer recovery coaching, given before and after training. Scores range from 0 to 10. Higher scores mean more knowledge.
Measured: Change from baseline to immediately post-training
Intention to Use, Modified UTAUT-2 Behavioral Intention
Behavioral intention (intention to use the platform) items from a modified Unified Theory of Acceptance and Use of Technology 2 (UTAUT-2) questionnaire, each rated from 1 (strongly disagree) to 7 (strongly agree) and averaged. Higher scores mean greater intention to use. Completed by participants in the platform conditions.
Measured: Immediately post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start7 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment. From May 2025 to August 2026, enrollment was by condition: participants were recruited separately into training as usual (TAU), TDPP-A, and TDPP-Z, and a Maryland localization cohort was recruited in June 2026, without random assignment. Under an IRB amendment approved August 21, 2026, all remaining participants are assigned at consent by simple individual-level randomization, 1:1, to TDPP-Z or TAU. Assignment is generated automatically and logged, and outreach staff are blinded to upcoming assignments. Recruitment into TDPP-A is complete. TDPP-A and the Maryland cohort are non-randomized comparison groups. The statistical analysis plan, to be finalized before database lock, will specify how participants enrolled before the amendment are handled alongside randomized participants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thrive Digital Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Christopher Pesce, JD/MBA, Principal investigator, Thrive Digital Health, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044531
- Sponsor's protocol ID
- 4R44AA030953
- Other IDs
- 4R44AA030953
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEVELOPMENT OF A NOVEL PEER RECOVERY SUPPORTER TRAINING PLATFORM TO DISSEMINATE EVIDENCE-BASED TRAINING AT SCALE
- ClinicalTrials.gov ID
- NCT07044531
- Acronym / sponsor ID
- 4R44AA030953
- Conditions
- Substance Use Disorders, Alcohol Use Disorders, Recovery Support Services, Peer Recovery Coaching
- Keywords
- Peer Recovery Support Services, Peer Recovery Coaching, Alcohol Use Disorders, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Thrive Digital Health, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 May 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Jul 2025 (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 tests an online training platform for peer recovery support specialists, people in recovery who support others with alcohol and other substance use problems. It compares the platform with standard live training on core peer recovery skills, rated by trained raters from a recorded interview, and on knowledge, usability, and intention to use the platform. Training conditions were first recruited separately. Since an IRB-approved change in August 2026, new participants are randomly assigned to either hybrid platform training or standard live training. A self-paced platform group and a Maryland group that used a version of the platform localized for that state are reported as non-randomized comparison groups. The study is Phase II of an SBIR Fast-Track award from the National Institute on Alcohol Abuse and Alcoholism.
Detailed description
Peer recovery support specialists (PRSS) are people with lived experience of recovery who provide non-clinical support to others with alcohol and other substance use disorders. This study evaluates the Thrive Digital Peer Platform (TDPP), an online training platform for PRSS. It is Phase II of an SBIR Fast-Track award from the National Institute on Alcohol Abuse and Alcoholism (R44AA030953). The Phase I pilot is registered separately as NCT07090590.
Training conditions. (1) Training as usual (TAU): the standard live, instructor-led CCAR course. (2) TDPP-A: the self-paced platform modules only. (3) TDPP-Z (hybrid): the self-paced modules plus an interactive roleplay practice component and recorded instructor video. (4) Maryland localization cohort (Aim 3): the self-paced content localized for a second state, delivered to prospective PRSS in Maryland in June and July 2026.
Allocation. The study was designed as a randomized trial. Randomized assignment was not feasible in practice, and enrollment from May 2025 through August 2026 proceeded by condition, with recruitment conducted separately for each condition. Under a protocol amendment approved by the IRB on August 21, 2026, all remaining participants are assigned at the point of consent by simple individual-level randomization, with equal allocation, to TDPP-Z or TAU. The assignment is generated automatically by the study system and logged, and outreach staff are blinded to upcoming assignments. Recruitment into TDPP-A is complete. TDPP-A and the Maryland cohort were recruited as groups and are non-randomized comparison groups. The statistical analysis plan, to be finalized before database lock, will specify how participants enrolled before the amendment are handled alongside randomized participants. The first three participants to complete the hybrid condition were pilot participants used to establish that condition's procedures.
Change to the hybrid condition. The original hybrid condition included three live videoconference sessions. They were removed in August 2026 because participants did not reliably attend them, and the condition now uses recorded instructor video and interactive roleplay practice with the same core content.
Outcomes. The primary outcome is skill and adherence on a recorded post-training behavioral interview, scored by trained raters blinded to condition using a modified Yale Adherence and Competence Scale II (YACS-II). Secondary outcomes are knowledge before and after training, usability (System Usability Scale), and intention to use the platform (modified UTAUT-2). Satisfaction and exit-interview feedback are also collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel assignment. From May 2025 to August 2026, enrollment was by condition: participants were recruited separately into training as usual (TAU), TDPP-A, and TDPP-Z, and a Maryland localization cohort was recruited in June 2026, without random assignment. Under an IRB amendment approved August 21, 2026, all remaining participants are assigned at consent by simple individual-level randomization, 1:1, to TDPP-Z or TAU. Assignment is generated automatically and logged, and outreach staff are blinded to upcoming assignments. Recruitment into TDPP-A is complete. TDPP-A and the Maryland cohort are non-randomized comparison groups. The statistical analysis plan, to be finalized before database lock, will specify how participants enrolled before the amendment are handled alongside randomized participants.
| Arm | Type | Receives |
|---|---|---|
| Training as Usual | Active comparator | Behavioral: Training-as-Usual (TAU)Participants complete the standard live, instructor-led Connecticut Community for Addiction Recovery (CCAR) training course. There are no digital platform modules. Participants enrolled before August 21, 2026 were recruited directly into this condition. From that date, participants are assigned to this condition by randomization, 1:1 with TDPP-Z. |
| TDPP-A (Asynchronous Only) | Experimental | Behavioral: TDPP-A (Asynchronous Platform)Participants complete the Thrive Digital Peer Platform (TDPP) in a fully self-paced format: 11 interactive modules using the Connect, Grow, Apply model, with peer-led stories and scenario-based exercises. There is no live facilitation. Participants were recruited directly into this condition from May to July 2025. Recruitment is complete. This is a non-randomized comparison group. |
| TDPP-Z (Hybrid) | Experimental | Behavioral: TDPP-Z (Hybrid)Participants complete the self-paced TDPP modules plus an interactive roleplay practice component and recorded instructor video. The three live videoconference sessions in the original design were removed in August 2026. Participants enrolled before August 21, 2026 were recruited directly into this condition, and the first three completers were pilot participants. From that date, participants are assigned to this condition by randomization, 1:1 with TAU. |
| Maryland Localization Cohort (Aim 3) | Experimental | Behavioral: Localized TDPP (Maryland)Prospective peer recovery support specialists in Maryland complete the self-paced TDPP content localized for Maryland, with the same assessments as the other conditions, in June and July 2026 (Aim 3). Recruited as a single group. This is a descriptive, non-randomized comparison cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Training-as-Usual (TAU)Standard live, instructor-led training course from the Connecticut Community for Addiction Recovery (CCAR), with no digital platform modules. | Behavioural | Training as Usual |
| TDPP-A (Asynchronous Platform)Participants engage with the Thrive Digital Peer Platform (TDPP), a fully asynchronous, self-paced online training program. The content includes 11 interactive modules structured using the Connect → Grow → Apply (CGA) learning framework, featuring peer stories, behavioral exercises, and scenario-based assessments. | Behavioural | TDPP-A (Asynchronous Only) |
| TDPP-Z (Hybrid)The self-paced TDPP modules plus an interactive roleplay practice component and recorded instructor video. This replaced three live, facilitator-led videoconference sessions in August 2026. | Behavioural | TDPP-Z (Hybrid) |
| Localized TDPP (Maryland)The self-paced TDPP content localized for Maryland peer recovery support specialists. | Behavioural | Maryland Localization Cohort (Aim 3) |
Primary outcome
Skill and Adherence Score, Modified Yale Adherence and Competence Scale II (YACS-II)
Time frame: Post-intervention (within 2 weeks of training completion)
Recorded post-training behavioral interview using standardized peer recovery scenarios, scored by two trained raters blinded to training condition using the Yale Adherence and Competence Scale II modified for peer recovery support. Adherence (frequency and extensiveness) and skill level are each rated from 1 to 7, and the raters' scores are averaged. Higher scores mean better adherence and skill.
3 secondary outcomes
System Usability Scale (SUS) Score
Time frame: Immediately post-training
Knowledge Test Score, Change From Baseline
Time frame: Change from baseline to immediately post-training
Intention to Use, Modified UTAUT-2 Behavioral Intention
Time frame: Immediately post-training
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Pesce, JD/MBA principal investigator
Thrive Digital Health, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training-as-Usual (TAU), TDPP-A (Asynchronous Platform) and TDPP-Z (Hybrid) in people with Substance Use Disorders and Alcohol Use Disorders, run by Thrive Digital Health, LLC 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?
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 29 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?
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 Christopher Pesce, JD/MBA (617-784-8715, cpesce@thrivedigitalhealth.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill and Adherence Score, Modified Yale Adherence and Competence Scale II (YACS-II) (time frame: Post-intervention (within 2 weeks of training completion)). 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 29 Sep 2026.