Occupational DeprivationNCT07035210
Impact of Self-directed Goals for Long-term Patients in a Forensic Hospital: A Mixed-Methods Pilot Study
A study testing Group and 1:1 occupational therapy sessions in people with Occupational Deprivation and Forensic Mental Health, run by Chapin Graham at 1 site in United States.
Trial summary
The goal of this study is to determine if supporting forensic patients in setting their own goals can impact occupational deprivation. This study is guided by this overarching research question: can setting and achieving self-directed goals improve occupational deprivation outcomes in long-term patients of a forensic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Deprivation, Forensic Mental Health
- What is being tested?
- Group and 1:1 occupational therapy sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 20 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is capable of providing consent to participate.
- Is at least 18 years of age.
- Resides at Rhode Island State Psychiatric Hospital.
- Hospital stay for a year or longer as of the anticipated start date of January 2025.
- No imminent discharge date due to the nature of their alleged criminal charges or current symptoms of their mental illness.
Who cannot join
- Have an imminent discharge date
- Having experienced positive symptoms of psychosis (i.e hallucinations, delusions, or thought disorganization) in the year prior to the January start date.
- Behavioral outburst resulting in restraints in the year prior to the January start date.
- Hold a primary diagnosis of antisocial personality disorder (ASPD).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island State Psychiatric Hospital
Cranston, Rhode Island, 02920
About this study
The goal of this study is to determine if supporting forensic patients in setting their own goals can impact occupational deprivation. This study is guided by this overarching research question: can setting and achieving self-directed goals improve occupational deprivation outcomes in long-term patients of a forensic psychiatric hospital? Participants were provided an educational group and occupational therapy treatment sessions to support goal setting within the forensic hospital.
Read the detailed description
The forensic hospital in which this research will be completed has patients with one of the following statuses:
- Incompetent to stand trial (IST): these patients are pretrial detainees with criminal charges who come from the department of corrections (DOC) remanded by the courts for psychiatric treatment and competency to stand trial restoration. Incompetent to stand trial means a patient is unable to participate in the court proceedings due to active symptoms of mental illness. Once recommended as competent, they can move forward to face their charges and hopefully be discharged from the hospital.
- Specialized services (SS): Patients admitted on SS are serving a sentence. While they are at the DOC, symptoms of their mental illness either emerge or get worse, impacting their safety to the extent that they need a hospital level of psychiatric care that cannot be provided in a correctional setting.
- Not guilty by reason of insanity (NGRI): A patient who has gone through the court process and adjudicated as NGRI. They have been committed to the department of mental health and reside in a forensic hospital. While there, they will continue to receive treatment and achieve incremental privileges approved first by the Psychiatric Services Review Board (PSRB) then by the court. They remain at the forensic hospital to serve time until they are up for parole.
The participants in the study will have a variety of these statuses. The population of long-term patient participants for this study are defined as having been hospitalized for at least one year at the start date of recruitment with no imminent discharge date. The participants will be assessed by the Canadian Occupational Performance Measure (COPM) before the first week of treatment to determine occupations they want to set goals for, and determine how they are currently performing those occupations as well as how satisfied they are with that performance. The project site has the COPM, so there is no funding necessary. The COPM can also be administered by any occupational therapist familiar with the assessment, so no additional training is necessary. After 10 weeks of treatment, the COPM will be used as a post-test as well.
Treatment includes: ten 1:1 occupational therapy sessions to achieve these goals and a ten week group with the focus of education on the goal-setting process. It is hypothesized that they will see improvement in satisfaction of the occupations they set goals around. It should be noted that all participants will have treatment goals set by the occupational therapy (OT) department that will be tracked and documented in the patients' medical chart, as is routine for OT treatment and per OT department policy.
Patient scores of performance and satisfaction will be compared between the first and second trial. Score changes are clinically significant if it is a change of two points or higher. To support the findings, patients' self-directed goals, when they are achieved, and any statements related to the setting and achieving of goals will be collected for qualitative analysis. This analysis and data will be deidentified using participant numbers and stored on a password protected Google Drive that can only be accessed by investigator (Chapin Graham) and site mentor (Natalie Petrucci). Hard copies of the COPM will be shredded once scanned into the Google Drive. All information on the Google Drive will be moved to trash and then the trash folder will be cleared one year after completion of the study.
Patients have the ability to leave the study at any time with no negative repercussions by simply refusing 1:1 treatment or group sessions. If they decompensate and exhibit psychotic behaviors, they will be discharged from the study involuntarily with no negative repercussions. Since the patients are their own legal guardians, they are fit to make informed consent for treatment at the hospital, including participation in this study.
Participant expectations
Participants will engage in assessment, evaluation, and treatment. The assessment and evaluations will serve to tailor their treatment to their current level of need. They will work with the OTS to schedule a weekly meeting time and, if a part of the variable group, attend all 10 weeks of the group. These sessions can be flexible based on hospital events, unexpected visits, or other conflicts. The expectations of the control group will be the same as the variable group, except for the attendance of the goal education group.
Data Collection
Assessment and evaluation will consist of the COPM and an in depth chart review to determine current level of function. The assessment write up, goals, 1:1 treatment notes and group notes will become part of the patient's medical record that is saved on the hospital encrypted drive. There will also be data that is collected solely for the purpose of the research, such as COPM scores, self-directed goals set, when the goals are achieved, and any quotes surrounding the goal-setting process.
This data will be stripped of identifying information and stored on a password protected Google Drive. Clients will be assigned a number and referred only by this. There will be no information related to birthday, age, hospital status, diagnosis, or criminal case. The only people with access will be the investigator (Chapin Graham) and site mentor (Natalie Petrucci). One year after the completion of the study, records on Google Drive will be moved to the trash folder and the trash folder will then be cleared, effectively destroying the records.
In order to be included in the study, patients will provide informed consent and be made aware that they are able to terminate their participation without any repercussions to their current treatment.
The routine of the hospital allows for participation in referral-based groups and patient treatment on occupational therapy caseload, assuring confidential participation in the study.
- Conditions
- Occupational Deprivation, Forensic Mental Health
- Being tested
- Group and 1:1 occupational therapy sessions
- Keywords
- Long-term patients, Forensic patients, Mental health patients, Occupational deprivation, Self-directed goals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group and 1:1 occupational therapy sessionsBehavioural
Patients will be educated on the goal setting process and setting self-directed goals aimed at occupations they identified as important in both group and 1:1 treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Self-directed Goals | Experimental | Participants will be setting self-directed goals based on the Canadian Occupational Performance Measure in skilled 1:1 occupational therapy sessions and working to achieving them as well as attending a goal-setting educational group. Receives: Behavioral: Group and 1:1 occupational therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Semi-structured interview identifying occupational participation. Participants rate occupations identified based on importance, performance, and satisfaction.
Measured: At enrollment and week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start6 Jan 2025
- Primary completion4 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Occupational DeprivationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chapin Graham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chapin Graham, Johnson & Wales University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035210
- Sponsor's protocol ID
- RPA#241002
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stephenson T, Leaman J, O'Moore E, Tran A, Plugge E. Time out of cell and time in purposeful activity and adverse mental health outcomes amongst people in prison: a literature review. Int J Prison Health. 2021 Jan 6;17(1):54-68. doi: 10.1108/IJPH-06-2020-0037.
PubMed 33634654Romero-Ayuso DM, Toledano-Gonzalez A, Pinilla-Cerezo M, Sanchez-Rodriguez O, Garcia-Arenas JJ, Trivino-Juarez JM, Ortiz-Rubio A. Occupational Balance and Emotional Regulation in People With and Without Serious Mental Illness. Can J Occup Ther. 2024 Mar;91(1):100-109. doi: 10.1177/00084174231178440. Epub 2023 Jun 4.
PubMed 37271981Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.
PubMed 10137673Laverdure P, Beisbier S. Occupation- and Activity-Based Interventions to Improve Performance of Activities of Daily Living, Play, and Leisure for Children and Youth Ages 5 to 21: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205050p1-7501205050p24. doi: 10.5014/ajot.2021.039560.
PubMed 33399053Clarke, C. (2003). Clinical application of the Canadian Model of Occupational Performance in a forensic rehabilitation hostel. British Journal of Occupational Therapy, 66(4).
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Self-directed Goals for Long-term Patients in a Forensic Hospital: A Mixed-Methods Pilot Study
- ClinicalTrials.gov ID
- NCT07035210
- Acronym / sponsor ID
- RPA#241002
- Conditions
- Occupational Deprivation, Forensic Mental Health
- Keywords
- Long-term patients, Forensic patients, Mental health patients, Occupational deprivation, Self-directed goals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chapin GrahamUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 25 Jun 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.
The goal of this study is to determine if supporting forensic patients in setting their own goals can impact occupational deprivation. This study is guided by this overarching research question: can setting and achieving self-directed goals improve occupational deprivation outcomes in long-term patients of a forensic psychiatric hospital? Participants were provided an educational group and occupational therapy treatment sessions to support goal setting within the forensic hospital.
Detailed description
The forensic hospital in which this research will be completed has patients with one of the following statuses:
- Incompetent to stand trial (IST): these patients are pretrial detainees with criminal charges who come from the department of corrections (DOC) remanded by the courts for psychiatric treatment and competency to stand trial restoration. Incompetent to stand trial means a patient is unable to participate in the court proceedings due to active symptoms of mental illness. Once recommended as competent, they can move forward to face their charges and hopefully be discharged from the hospital.
- Specialized services (SS): Patients admitted on SS are serving a sentence. While they are at the DOC, symptoms of their mental illness either emerge or get worse, impacting their safety to the extent that they need a hospital level of psychiatric care that cannot be provided in a correctional setting.
- Not guilty by reason of insanity (NGRI): A patient who has gone through the court process and adjudicated as NGRI. They have been committed to the department of mental health and reside in a forensic hospital. While there, they will continue to receive treatment and achieve incremental privileges approved first by the Psychiatric Services Review Board (PSRB) then by the court. They remain at the forensic hospital to serve time until they are up for parole.
The participants in the study will have a variety of these statuses. The population of long-term patient participants for this study are defined as having been hospitalized for at least one year at the start date of recruitment with no imminent discharge date. The participants will be assessed by the Canadian Occupational Performance Measure (COPM) before the first week of treatment to determine occupations they want to set goals for, and determine how they are currently performing those occupations as well as how satisfied they are with that performance. The project site has the COPM, so there is no funding necessary. The COPM can also be administered by any occupational therapist familiar with the assessment, so no additional training is necessary. After 10 weeks of treatment, the COPM will be used as a post-test as well.
Treatment includes: ten 1:1 occupational therapy sessions to achieve these goals and a ten week group with the focus of education on the goal-setting process. It is hypothesized that they will see improvement in satisfaction of the occupations they set goals around. It should be noted that all participants will have treatment goals set by the occupational therapy (OT) department that will be tracked and documented in the patients' medical chart, as is routine for OT treatment and per OT department policy.
Patient scores of performance and satisfaction will be compared between the first and second trial. Score changes are clinically significant if it is a change of two points or higher. To support the findings, patients' self-directed goals, when they are achieved, and any statements related to the setting and achieving of goals will be collected for qualitative analysis. This analysis and data will be deidentified using participant numbers and stored on a password protected Google Drive that can only be accessed by investigator (Chapin Graham) and site mentor (Natalie Petrucci). Hard copies of the COPM will be shredded once scanned into the Google Drive. All information on the Google Drive will be moved to trash and then the trash folder will be cleared one year after completion of the study.
Patients have the ability to leave the study at any time with no negative repercussions by simply refusing 1:1 treatment or group sessions. If they decompensate and exhibit psychotic behaviors, they will be discharged from the study involuntarily with no negative repercussions. Since the patients are their own legal guardians, they are fit to make informed consent for treatment at the hospital, including participation in this study.
Participant expectations
Participants will engage in assessment, evaluation, and treatment. The assessment and evaluations will serve to tailor their treatment to their current level of need. They will work with the OTS to schedule a weekly meeting time and, if a part of the variable group, attend all 10 weeks of the group. These sessions can be flexible based on hospital events, unexpected visits, or other conflicts. The expectations of the control group will be the same as the variable group, except for the attendance of the goal education group.
Data Collection
Assessment and evaluation will consist of the COPM and an in depth chart review to determine current level of function. The assessment write up, goals, 1:1 treatment notes and group notes will become part of the patient's medical record that is saved on the hospital encrypted drive. There will also be data that is collected solely for the purpose of the research, such as COPM scores, self-directed goals set, when the goals are achieved, and any quotes surrounding the goal-setting process.
This data will be stripped of identifying information and stored on a password protected Google Drive. Clients will be assigned a number and referred only by this. There will be no information related to birthday, age, hospital status, diagnosis, or criminal case. The only people with access will be the investigator (Chapin Graham) and site mentor (Natalie Petrucci). One year after the completion of the study, records on Google Drive will be moved to the trash folder and the trash folder will then be cleared, effectively destroying the records.
In order to be included in the study, patients will provide informed consent and be made aware that they are able to terminate their participation without any repercussions to their current treatment.
The routine of the hospital allows for participation in referral-based groups and patient treatment on occupational therapy caseload, assuring confidential participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-directed Goals | Experimental | Behavioral: Group and 1:1 occupational therapy sessionsParticipants will be setting self-directed goals based on the Canadian Occupational Performance Measure in skilled 1:1 occupational therapy sessions and working to achieving them as well as attending a goal-setting educational group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is capable of providing consent to participate.
- Is at least 18 years of age.
- Resides at Rhode Island State Psychiatric Hospital.
- Hospital stay for a year or longer as of the anticipated start date of January 2025.
- No imminent discharge date due to the nature of their alleged criminal charges or current symptoms of their mental illness.
Key exclusion criteria (4 listed)
- Have an imminent discharge date
- Having experienced positive symptoms of psychosis (i.e hallucinations, delusions, or thought disorganization) in the year prior to the January start date.
- Behavioral outburst resulting in restraints in the year prior to the January start date.
- Hold a primary diagnosis of antisocial personality disorder (ASPD).
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 |
|---|---|---|
| Group and 1:1 occupational therapy sessionsPatients will be educated on the goal setting process and setting self-directed goals aimed at occupations they identified as important in both group and 1:1 treatment sessions. | Behavioural | Self-directed Goals |
Primary outcome
Canadian Occupational Performance Measure
Time frame: At enrollment and week 11
Semi-structured interview identifying occupational participation. Participants rate occupations identified based on importance, performance, and satisfaction.
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 Jun 2025.
- Background: PubMed 33634654Stephenson T, Leaman J, O'Moore E, Tran A, Plugge E. Time out of cell and time in purposeful activity and adverse mental health outcomes amongst people in prison: a literature review. Int J Prison Health. 2021 Jan 6;17(1):54-68. doi: 10.1108/IJPH-06-2020-0037.
- Background: PubMed 37271981Romero-Ayuso DM, Toledano-Gonzalez A, Pinilla-Cerezo M, Sanchez-Rodriguez O, Garcia-Arenas JJ, Trivino-Juarez JM, Ortiz-Rubio A. Occupational Balance and Emotional Regulation in People With and Without Serious Mental Illness. Can J Occup Ther. 2024 Mar;91(1):100-109. doi: 10.1177/00084174231178440. Epub 2023 Jun 4.
- Background: PubMed 10137673Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.
- Background: PubMed 33399053Laverdure P, Beisbier S. Occupation- and Activity-Based Interventions to Improve Performance of Activities of Daily Living, Play, and Leisure for Children and Youth Ages 5 to 21: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205050p1-7501205050p24. doi: 10.5014/ajot.2021.039560.
- BackgroundClarke, C. (2003). Clinical application of the Canadian Model of Occupational Performance in a forensic rehabilitation hostel. British Journal of Occupational Therapy, 66(4).
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group and 1:1 occupational therapy sessions in people with Occupational Deprivation and Forensic Mental Health, run by Chapin Graham 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 5 inclusion and 4 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 Jun 2025. 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?
Canadian Occupational Performance Measure (time frame: At enrollment and week 11). 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 NCT07035210, which also lists 5 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 25 Jun 2025.