Acquired Brain InjuryREFECO-OPNCT04560777
Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children, Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury
A study testing CO-OP intervention in people with Acquired Brain Injury, run by Hopitaux de Saint-Maurice at 2 sites in France.
Trial summary
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- CO-OP intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2020to 27 Jul 2022
- 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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child/adolescent/young adult aged between 8 and 21 years old, hospitalized in the Acquired Neurological Pathologies Service of the Saint-Maurice Hospitals or in the Medical and Pedagogical Centre for Adolescents of Neufmoutiers-en-Brie, and possibly schooled in this service.
- Diagnosis of acquired brain injury, for at least 6 months.
- Child/adolescent/young adult presenting executive function deficits as determined by the neuropsychological assessment (standardized tests and/or questionnaire).
- Vision and hearing normal or sufficient to communicate effectively (with appropriate correction if necessary).
- Having sufficient speaking and comprehension skills to communicate effectively and accurately.
- Enrollment in a Medicare plan or eligible beneficiary.
- Agreement of the child/young person and informed consent expressed by the holders of parental authority. Consent of the young adult (18-21 years of age).
Who cannot join
- Non-Francophone child/teenager/young adult and/or non-Francophone parents.
- With an intellectual disability (total IQ <70), or severe impairment in comprehension, memory or attention, not compatible with understanding the goals of the rehabilitation and participation in 45-minute sessions.
- Neurological, psychiatric, genetic or learning disorder diagnosed prior to the occurrence of the acquired brain injury.
- Severe anxiety and/or depressive disorder diagnosed that is not compatible with participation in the study.
- Inability to commit until the end of the CO-OP rehabilitation phase (e.g., planned relocation, planned hospital discharge before the end of the 14 CO-OP sessions, i.e., 10 weeks including baseline and CO-OP rehabilitation).
- Major subject under guardianship or curatorship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Médical et Pédagogique pour Adolescents
Neufmoutiers-en-Brie, 77610
Hôpitaux de Saint-Maurice
Saint-Maurice, 94410
About this study
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration.
Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning.
Read more
The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles.
It has been shown to be effective in a variety of populations, but has been little explored in children with ABI. The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging, but needs to be confirmed. This study falls within this framework.
Primary objective:
- To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.
- Maintenance of acquired knowledge
- Generalization and transfer
- Impact of a consolidation session on generalization and transfer Secondary objectives:
- Gather the experience of family members/caregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions.
- Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family members/caregivers.
Read the detailed description
Twelve participants will be included (aged 8 to 21 years old). Participants will have different assessment times, before, during and after the CO-OP intervention (immediate post-intervention, 2, 4 and 6-months post-intervention). Parents will be asked to answer questionnaires and interview and to participate in certain CO-OP sessions, if they can.
They will choose four objectives (problematic everyday life activities they want to improve). Three will be worked on in CO-OP sessions, the fourth will be the control objective.
The duration of the baseline, as well as the order of introduction of the objectives and the starting point of the objectives, are randomized.
Participants will have 14 sessions of rehabilitation with the CO-OP approach (2 sessions per week for 7 weeks).
- Conditions
- Acquired Brain Injury
- Being tested
- CO-OP intervention
- Keywords
- Cognitive Orientation to daily Occupational Performance, rehabilitation, executive functions, child acquired brain injury, teenagers, young adults, acquired brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OP interventionOther
The general structure of the intervention will follow the original key principles of CO-OP, with some adjustments to adapt it to the specificities of the ABI population (14 CO-OP sessions vs 10 in the original protocol).
The global strategy will be taught to the participant at the first session. The following sessions will be consisted of an process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the participant will be experiencing when performing the self-selected tasks. In addition, "homework" will be assigned to encourage the application and practice of the cognitive strategies discovered during the intervention sessions. Parents will be invited to attend the sessions if it will be possible for them. In any case, the global strategy, as well as the progress of the child, will be explained to the parents.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | CO-OP intervention Receives: Other: CO-OP intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Goal Attainment Scaling (GAS) change
Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales in order to quantify progress toward defined goals.
GAS methodology consists in:
- Defining a rehabilitation goal;
- Choosing an observable behaviour that reflects the degree of goal attainment;
- Defining the patient's initial level with respect to the goal;
- Defining five goal attainment levels (ranging from a ''no change'' to a ''much better than expected outcome'');
- Evaluating the patient after a defined time interval;
- Calculating the overall attainment score for all the rehabilitation goals. A five-point scale is used: ''-2'' is the initial pretreatment (baseline) level, ''-1'' represents progression towards the goal without goal attainment, ''0'' is the expected level after treatment, (and therefore, the ''most likely'' level after treatment), ''+1'' represents a better outcome than expected, and ''+2'' is the best possible outcome that could have been expected for this goal.
Measured: Baseline to 6-months post-intervention (Two times per week during baseline and intervention phase for each 4 chosen-goal ; one time at 2, 4 and 6-months post-intervention)
Secondary outcomes (5)
Canadian Occupational Performance Measure (COPM)
This semi-structured interview helps children/parents identify problematic occupations in different daily areas. COPM will be used: (1) To determine (only with the child) the 4 problematic occupations identified as the most important (3 will be used as target goals, while the 4 will serve as a control goal); (2) To determine changes in occupational performance in self-selected goals: children and parents will rated their performance and satisfaction associated with these 4 occupations.
Performance and satisfaction are rated by children and parents on a scale of 1 to 10 (1= not at all able to perform the activity (performance) / not at all satisfied with the way the activity is performed (satisfaction); 10 = perfectly able to perform the activity (performance) / perfectly satisfied with the way the activity is performed (satisfaction). A difference of 2 points between pre- and post-intervention is clinically significant.
Measured: Before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
The parent and teacher report forms of the Behavior Rating Inventory of Executive Function (BRIEF, or BRIEF-A for adults'version) provide an ecological assessment of executive functioning through its repercussions in family and school context. Currently, this questionnaire is the best validated and most widely used in children in various congenital, developmental or acquired conditions.
The outcome measure is the Global Executive Composite score (GEC) T-Scores (Mean: 50; SD: 10; clinical range cutoff: T-Scores≥65).
Measured: Minimum 3-maximum 6 assessments during the baseline (according the duration of the baseline), week 2, 4 and 6 during the intervention, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Évaluation des Pratiques Éducatives Parentales (EPEP, Parental Childrearing Behavior Scale for French-Speaking Parents, Children, and Adolescents)
The EPEP represents an efficient solution to the search for conceptually and psychometrically sound instruments to assess parents' child-rearing behavior. A 5-point Likert-type scale is provided for each item ranging from "never" "to always" (explaining to parents that there are no right or wrong answers). The results are obtained by averaging the scores per subscale (8 subscales). The purpose of this evaluation is to define the parenting educational style: there are not a better or worse outcome per se.
Measured: one time before baseline
Questionnaire Engagement des Proches
The objective of this questionnaire is to collect information on the use of CO-OP by family caregivers with the participant, outside of rehabilitation sessions. No scale of score, just a collection of factual facts.
Measured: week 2, 4 and 6 during the intervention
Entretien Engagement des Proches
The objective of this interview is to collect information on the experience of use of CO-OP by family caregivers with the participant, outside of rehabilitation sessions. No scale of score, the interviews will be analyzed according to a qualitative description.
Measured: immediate post-intervention, 4 and 6 months-post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start20 Nov 2020
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single case experimental study design with multiple baselines across individuals and behaviors. Randomization: 1. Which patient starts when the COOP sessions? 2. What are the possible starting points for the 3 goals to be worked on? 3. Which of the 4 goals ABCD is assigned to which goal number? The most important goal (A) will necessarily be worked on first. We will draw lots to determine the order in which the goals will be worked on and which goal will be designated as the control goal.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopitaux de Saint-Maurice
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Hôpital Civil de Strasbourg, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Mathilde CHEVIGNARD, PhD, Study director, Hopitaux de Saint-Maurice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560777
- Sponsor's protocol ID
- PHRIP-19-0074
- Acronym
- REFECO-OP
- Status last verified
- Jul 2022
- First submitted
- 15 Sep 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We think it would be interesting to share the IPD with other researchers (especially Canadian researchers), but we have not yet defined the terms of this sharing.
Publications
Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
PubMed 23562111Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. doi: 10.1177/0008417416651277. Epub 2016 Jun 14.
PubMed 27301479Manolov R, Lebrault H, Krasny-Pacini A. How to assess and take into account trend in single-case experimental design data. Neuropsychol Rehabil. 2024 Apr;34(3):388-429. doi: 10.1080/09602011.2023.2190129. Epub 2023 Mar 24.
PubMed 36961228
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Use of the Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) With Children, Teenagers and Young Adults With Executive Functions Deficits Following Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04560777
- Acronym / sponsor ID
- REFECO-OP / PHRIP-19-0074
- Conditions
- Acquired Brain Injury
- Keywords
- Cognitive Orientation to daily Occupational Performance, rehabilitation, executive functions, child acquired brain injury, teenagers, young adults, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hopitaux de Saint-MauriceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Hôpital Civil de Strasbourg, Ministry of Health, France
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 23 Sep 2020 (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.
Acquired brain injury (ABI) in childhood are the cause of disabling motor, cognitive and behavioural disorders, with severe consequences on the later development of autonomy and learning, with long-term repercussions on independence for activities of daily living, and social and professional integration.
Among cognitive disorders, executive function (EF) deficits are among the most frequent and disabling, with major consequences on the development of autonomy and the course of schooling and learning.
The Cognitive Orientation to daily Occupational Performance (CO-OP) could be an interesting approach for the rehabilitation of these consequences. CO-OP is a performance-based treatment approach for children and adults who experience difficulties performing the skills they want to, need to or are expected to perform. CO-OP is a specifically tailored, active client-centered approach that engages the individual at the meta-cognitive level to solve performance problems. Focused on enabling success, the CO-OP approach employs collaborative goal setting, dynamic performance analysis, cognitive strategy use, guided discovery, and enabling principles.
It has been shown to be effective in a variety of populations, but has been little explored in children with ABI. The hypothesis that CO-OP is effective in improving the occupational performance and executive functioning of these children on a daily basis is emerging, but needs to be confirmed. This study falls within this framework.
Primary objective:
- To measure the distance maintenance of the knowledge acquired through rehabilitation, as well as the generalization and transfer into everyday life.
- Maintenance of acquired knowledge
- Generalization and transfer
- Impact of a consolidation session on generalization and transfer Secondary objectives:
- Gather the experience of family members/caregivers in accompanying their child in the CO-OP process outside of rehabilitation sessions.
- Establish the parental educational style and identify whether there is a link between the parental educational style and the commitment of the family members/caregivers.
Detailed description
Twelve participants will be included (aged 8 to 21 years old). Participants will have different assessment times, before, during and after the CO-OP intervention (immediate post-intervention, 2, 4 and 6-months post-intervention). Parents will be asked to answer questionnaires and interview and to participate in certain CO-OP sessions, if they can.
They will choose four objectives (problematic everyday life activities they want to improve). Three will be worked on in CO-OP sessions, the fourth will be the control objective.
The duration of the baseline, as well as the order of introduction of the objectives and the starting point of the objectives, are randomized.
Participants will have 14 sessions of rehabilitation with the CO-OP approach (2 sessions per week for 7 weeks).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental study design with multiple baselines across individuals and behaviors. Randomization: 1. Which patient starts when the COOP sessions? 2. What are the possible starting points for the 3 goals to be worked on? 3. Which of the 4 goals ABCD is assigned to which goal number? The most important goal (A) will necessarily be worked on first. We will draw lots to determine the order in which the goals will be worked on and which goal will be designated as the control goal.
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Other: CO-OP interventionCO-OP intervention |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Child/adolescent/young adult aged between 8 and 21 years old, hospitalized in the Acquired Neurological Pathologies Service of the Saint-Maurice Hospitals or in the Medical and Pedagogical Centre for Adolescents of Neufmoutiers-en-Brie, and possibly schooled in this service.
- Diagnosis of acquired brain injury, for at least 6 months.
- Child/adolescent/young adult presenting executive function deficits as determined by the neuropsychological assessment (standardized tests and/or questionnaire).
- Vision and hearing normal or sufficient to communicate effectively (with appropriate correction if necessary).
- Having sufficient speaking and comprehension skills to communicate effectively and accurately.
Key exclusion criteria (6 listed)
- Non-Francophone child/teenager/young adult and/or non-Francophone parents.
- With an intellectual disability (total IQ <70), or severe impairment in comprehension, memory or attention, not compatible with understanding the goals of the rehabilitation and participation in 45-minute sessions.
- Neurological, psychiatric, genetic or learning disorder diagnosed prior to the occurrence of the acquired brain injury.
- Severe anxiety and/or depressive disorder diagnosed that is not compatible with participation in the study.
- Inability to commit until the end of the CO-OP rehabilitation phase (e.g., planned relocation, planned hospital discharge before the end of the 14 CO-OP sessions, i.e., 10 weeks including baseline and CO-OP rehabilitation).
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 |
|---|---|---|
| CO-OP interventionThe general structure of the intervention will follow the original key principles of CO-OP, with some adjustments to adapt it to the specificities of the ABI population (14 CO-OP sessions vs 10 in the original protocol). The global strategy will be taught to the participant at the first session. The following sessions will be consisted of an process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns" the participant will be experiencing when performing the self-selected tasks. In addition, "homework" will be assigned to encourage the application and practice of the cognitive strategies discovered during the intervention sessions. Parents will be invited to attend the sessions if it will be possible for them. In any case, the global strategy, as well as the progress of the child, will be explained to the parents. | Other | experimental arm |
Primary outcome
Assessment of Goal Attainment Scaling (GAS) change
Time frame: Baseline to 6-months post-intervention (Two times per week during baseline and intervention phase for each 4 chosen-goal ; one time at 2, 4 and 6-months post-intervention)
Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales in order to quantify progress toward defined goals. GAS methodology consists in: * Defining a rehabilitation goal; * Choosing an observable behaviour that reflects the degree of goal attainment; * Defining the patient's initial level with respect to the goal; * Defining five goal attainment levels (ranging from a ''no change'' to a ''much better than expected outcome''); * Evaluating the patient after a defined time interval; * Calculating the overall attainment score for all the rehabilitation goals. A five-point scale is used: ''-2'' is the initial pretreatment (baseline) level, ''-1'' represents progression towards the goal without goal attainment, ''0'' is the expected level after treatment, (and therefore, the ''most likely'' level after treatment), ''+1'' represents a better outcome than expected, and ''+2'' is the best possible outcome that could have been expected for this goal.
5 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: Before baseline, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Minimum 3-maximum 6 assessments during the baseline (according the duration of the baseline), week 2, 4 and 6 during the intervention, at immediate post-intervention, at 2, 4 and 6-months post-intervention.
Évaluation des Pratiques Éducatives Parentales (EPEP, Parental Childrearing Behavior Scale for French-Speaking Parents, Children, and Adolescents)
Time frame: one time before baseline
Questionnaire Engagement des Proches
Time frame: week 2, 4 and 6 during the intervention
Entretien Engagement des Proches
Time frame: immediate post-intervention, 4 and 6 months-post-intervention
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 28 Jul 2022.
- Background: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Background: PubMed 23562111Krasny-Pacini A, Hiebel J, Pauly F, Godon S, Chevignard M. Goal attainment scaling in rehabilitation: a literature-based update. Ann Phys Rehabil Med. 2013 Apr;56(3):212-30. doi: 10.1016/j.rehab.2013.02.002. Epub 2013 Feb 28.
- Background: PubMed 27301479Scammell EM, Bates SV, Houldin A, Polatajko HJ. The Cognitive Orientation to daily Occupational Performance (CO-OP): A scoping review. Can J Occup Ther. 2016 Oct;83(4):216-225. doi: 10.1177/0008417416651277. Epub 2016 Jun 14.
- Derived from this study: PubMed 36961228Manolov R, Lebrault H, Krasny-Pacini A. How to assess and take into account trend in single-case experimental design data. Neuropsychol Rehabil. 2024 Apr;34(3):388-429. doi: 10.1080/09602011.2023.2190129. Epub 2023 Mar 24.
- Individual participant dataSharing planned: Undecided. We think it would be interesting to share the IPD with other researchers (especially Canadian researchers), but we have not yet defined the terms of this sharing.
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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.
Mathilde CHEVIGNARD, PhD study director
Hopitaux de Saint-Maurice
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP intervention in people with Acquired Brain Injury, run by Hopitaux de Saint-Maurice at 2 sites in France.
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 7 inclusion and 6 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Assessment of Goal Attainment Scaling (GAS) change (time frame: Baseline to 6-months post-intervention (Two times per week during baseline and intervention phase for each 4 chosen-goal ; one time at 2, 4 and 6-months post-intervention)). 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 NCT04560777, which also lists 4 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 28 Jul 2022.