DepressionNCT03423212
Just Do You Program for Young Adults With Serious Mental IIlness
A study testing Just Do You in people with Depression and Bipolar Disorder, run by New York University at 1 site in United States.
Trial summary
Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Depression, Bipolar Disorder, Psychosis
- What is being tested?
- Just Do You
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 7 Mar 2020
- 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between the ages of 18 and 28
- living with a serious mental illness (i.e., mood, anxiety, schizophrenia-spectrum)
- attending personalized recovery-oriented services (PROS)
- formerly involved with public systems of care
Who cannot join
- cognitive impairments (i.e., young adult cannot understand consent process or IQ<70)
- non-English speaking (we will include individuals whose primary language is not English, but are able to comprehend and speak English).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mt Eden Personalized Recovery Oriented Services
New York, New York, 10457
About this study
Official title: Just Do You Program for Young Adults With Serious Mental IIlness: A Randomized Controlled Trial
Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care.
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Read the detailed description
Background
Young adults have elevated rates of serious mental illnesses and they often do not receive consistent mental health care. This is a considerable challenge for public health, as most often mental health conditions persist into adulthood. Continuing to engage this population in their professional mental health treatment has been a pervasive challenge globally. Few mental health interventions have been designed specifically for young adults and none are conceptualized as meta-interventions or orientation programs. Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services).
Methods/design
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, the investigators will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Discussion
The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care. Continuity of care among this population is a serious challenge and Just Do You has the potential to address this challenge in the service system for poor, young adults living in low-resourced communities. If it is shown to be successful in this setting, it could likely be used to address the continuity of care issue more broadly in additional settings that serve young adults with serious mental illness. It may enhance the menu of care options for those who have been recently diagnosed with a serious mental health condition, providing them with an orientation for how professional mental health care can help them. The program is recovery-oriented, builds on the best evidence to date, and is in line with both local and national health care reform efforts.
- Conditions
- Depression, Bipolar Disorder, Psychosis, Anxiety Disorders
- Being tested
- Just Do You, Active Control
- Medical subject headings
- Depression, Bipolar Disorder, Psychotic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Just Do YouBehavioural
Just Do You is an intervention designed to keep young adults connected to their professional behavioral health treatments. It is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to increase young adult engagement in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The first session consists of the following components: 1) Welcome; Group Guidelines, Purpose, 2) Discuss Recovery Principles; Narrative of Role Model; 3) Video of Celebrity Service User and Discussion, and 4) Recovery Goals (and role of services in that). The second session consists of: 1) What are services \& how can they help? 2) Visual art exercise -- Cause of SMI and validation, 3) Maintaining my Medicaid Insurance, and 4) Discussion of Systemic Barriers.
Active ControlBehavioural
The active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Condition | Experimental | Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere. Receives: Behavioral: Just Do You |
| Treatment as Usual Condition | No intervention | Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention. |
| Active Control Condition | Active comparator | Participants assigned to the active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Measured: Assessed 4 weeks following baseline
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Measured: Assessed 3 months following baseline
Secondary outcomes (4)
Adherence to medication
Past week adherence to mental health-related medications
Measured: Assessed 4 weeks following baseline
Adherence to medication
Past week adherence to mental health-related medications
Measured: Assessed 3 months following baseline
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement.
Measured: Assessed 4 weeks following baseline
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement.
Measured: Assessed 3 months following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start31 Jan 2018
- Primary completion7 Mar 2020
- Study completion7 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle R Munson, PhD, Principal investigator, New York UniversityJames Jaccard, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423212
- Sponsor's protocol ID
- R34MH111861-01
- Status last verified
- Sep 2020
- First submitted
- 4 Jan 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Munson MR, Jaccard J, Scott LD Jr, Moore KL, Narendorf SC, Cole AR, Shimizu R, Rodwin AH, Jenefsky N, Davis M, Gilmer T. Outcomes of a Metaintervention to Improve Treatment Engagement Among Young Adults With Serious Mental Illnesses: Application of a Pilot Randomized Explanatory Design. J Adolesc Health. 2021 Nov;69(5):790-796. doi: 10.1016/j.jadohealth.2021.04.023. Epub 2021 Jun 4.
PubMed 34099390Munson MR, Jaccard JJ, Scott LD Jr, Narendorf SC, Moore KL, Jenefsky N, Cole A, Davis M, Gilmer T, Shimizu R, Pleines K, Cooper K, Rodwin AH, Hylek L, Amaro A. Engagement intervention versus treatment as usual for young adults with serious mental illness: a randomized pilot trial. Pilot Feasibility Stud. 2020 Jul 23;6:107. doi: 10.1186/s40814-020-00650-w. eCollection 2020.
PubMed 32714561
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Just Do You Program for Young Adults With Serious Mental IIlness: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03423212
- Acronym / sponsor ID
- R34MH111861-01
- Conditions
- Depression, Bipolar Disorder, Psychosis, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 7 Mar 2020 (actual)
- Study completion
- 7 Mar 2020 (actual)
- First posted
- 6 Feb 2018 (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.
Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care.
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Detailed description
Background
Young adults have elevated rates of serious mental illnesses and they often do not receive consistent mental health care. This is a considerable challenge for public health, as most often mental health conditions persist into adulthood. Continuing to engage this population in their professional mental health treatment has been a pervasive challenge globally. Few mental health interventions have been designed specifically for young adults and none are conceptualized as meta-interventions or orientation programs. Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services).
Methods/design
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, the investigators will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Discussion
The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care. Continuity of care among this population is a serious challenge and Just Do You has the potential to address this challenge in the service system for poor, young adults living in low-resourced communities. If it is shown to be successful in this setting, it could likely be used to address the continuity of care issue more broadly in additional settings that serve young adults with serious mental illness. It may enhance the menu of care options for those who have been recently diagnosed with a serious mental health condition, providing them with an orientation for how professional mental health care can help them. The program is recovery-oriented, builds on the best evidence to date, and is in line with both local and national health care reform efforts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Condition | Experimental | Behavioral: Just Do YouParticipants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere. |
| Treatment as Usual Condition | No intervention | –Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention. |
| Active Control Condition | Active comparator | Behavioral: Active ControlParticipants assigned to the active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- between the ages of 18 and 28
- living with a serious mental illness (i.e., mood, anxiety, schizophrenia-spectrum)
- attending personalized recovery-oriented services (PROS)
- formerly involved with public systems of care
Key exclusion criteria (2 listed)
- cognitive impairments (i.e., young adult cannot understand consent process or IQ<70)
- non-English speaking (we will include individuals whose primary language is not English, but are able to comprehend and speak English).
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 |
|---|---|---|
| Just Do YouJust Do You is an intervention designed to keep young adults connected to their professional behavioral health treatments. It is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to increase young adult engagement in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The first session consists of the following components: 1) Welcome; Group Guidelines, Purpose, 2) Discuss Recovery Principles; Narrative of Role Model; 3) Video of Celebrity Service User and Discussion, and 4) Recovery Goals (and role of services in that). The second session consists of: 1) What are services \& how can they help? 2) Visual art exercise -- Cause of SMI and validation, 3) Maintaining my Medicaid Insurance, and 4) Discussion of Systemic Barriers. | Behavioural | Experimental Condition |
| Active ControlThe active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population. | Behavioural | Active Control Condition |
Primary outcome
Adherence to PROS program
Time frame: Assessed 4 weeks following baseline
Past week attendance to mental health appointments at PROS
Adherence to PROS program
Time frame: Assessed 3 months following baseline
Past week attendance to mental health appointments at PROS
4 secondary outcomes
Adherence to medication
Time frame: Assessed 4 weeks following baseline
Adherence to medication
Time frame: Assessed 3 months following baseline
Client Engagement in Child Protective Services Scale
Time frame: Assessed 4 weeks following baseline
Client Engagement in Child Protective Services Scale
Time frame: Assessed 3 months following baseline
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 3 Nov 2022.
- Derived from this study: PubMed 34099390Munson MR, Jaccard J, Scott LD Jr, Moore KL, Narendorf SC, Cole AR, Shimizu R, Rodwin AH, Jenefsky N, Davis M, Gilmer T. Outcomes of a Metaintervention to Improve Treatment Engagement Among Young Adults With Serious Mental Illnesses: Application of a Pilot Randomized Explanatory Design. J Adolesc Health. 2021 Nov;69(5):790-796. doi: 10.1016/j.jadohealth.2021.04.023. Epub 2021 Jun 4.
- Derived from this study: PubMed 32714561Munson MR, Jaccard JJ, Scott LD Jr, Narendorf SC, Moore KL, Jenefsky N, Cole A, Davis M, Gilmer T, Shimizu R, Pleines K, Cooper K, Rodwin AH, Hylek L, Amaro A. Engagement intervention versus treatment as usual for young adults with serious mental illness: a randomized pilot trial. Pilot Feasibility Stud. 2020 Jul 23;6:107. doi: 10.1186/s40814-020-00650-w. eCollection 2020.
- 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.
Michelle R Munson, PhD principal investigator
New York University
James Jaccard, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just Do You in people with Depression and Bipolar Disorder, run by New York University 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 4 inclusion and 2 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 3 Nov 2022. 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?
Adherence to PROS program (time frame: Assessed 4 weeks following baseline). 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?
On the ClinicalTrials.gov record for NCT03423212, which also lists 2 linked publications.
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 3 Nov 2022.