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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Group and 1:1 occupational therapy sessions
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

Other trials in United States

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.

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 groups in NCT07035210
Study groupRoleWhat they receive
Self-directed GoalsExperimentalParticipants 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.

  1. 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.

  1. First posted25 Jun 2025
  2. Study start6 Jan 2025
  3. Primary completion4 Apr 2025
  4. Study completion20 Apr 2025

Resources

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)
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 33634654
  • Romero-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 37271981
  • Law 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 10137673
  • Laverdure 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 33399053
  • Clarke, C. (2003). Clinical application of the Canadian Model of Occupational Performance in a forensic rehabilitation hostel. British Journal of Occupational Therapy, 66(4).

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.

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