Depression Clinical Trial
— PrismaOfficial title:
Psychoeducation for Adults With Autism and Their Significant Others/Family Members
Verified date | December 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prisma is a four-session psychoeducational intervention administered in groups for individuals with ASD together with their family members and significant others. The aspiration is to make Prisma into an affordable, accessible and available intervention. This includes taking into account a great age spectrum, differences in comorbidity as well as other varied qualities that characterize this group. Acknowledging this diversity and helping to create opportunity for these individuals is of great importance in order to follow national as well as international legislations of the patient's rights. The aim of the proposed studies is to evaluate the feasibility and effect of Prisma in adults (18 or over) with ASD and their family members/significant others in an outpatient clinical habilitation context.
Status | Completed |
Enrollment | 718 |
Est. completion date | September 15, 2020 |
Est. primary completion date | September 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults with autism spectrum disorder - Should meet DSM-5 criteria for ASD and/or ICD-10 for one of the autism diagnoses under F84. - Diagnoses are set within the Swedish healthcare system - The significant other should also be an adult (18 years or older) and could be a parent, sibling, partner, friend or what the participant with ASD thought of as a significant other. Exclusion Criteria: - Intellectual disability. - Insufficient command of the Swedish language/ unable to understand the content. - Severe psychiatric comorbidity that made participation difficult (e.g. severe depression, severe suicidality, severe anxiety), other circumstances that could make participation hard (e.g. homelessness) and severe difficulties or discomfort participating in groups. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Study 1: Evaluation of session 1 | This includes five items scored on a Likert scale ranging from 0 ("not at all") to 4 ("yes, absolutely"), with item one to three concerning the participants opinion of the content and knowledge acquired and item four to five whether it was useful to trade experiences with the other participants.
Intervention satisfaction was measured with an evaluation questionnaire after each session, a modified version of the Session evaluation form (SEF: Bramham et al., 2009; Hirvikoski et al., 2017). High values are indication of statisfaction: After today's lecture, my knowledge about ASD has increased I will benefit from what we went through on today's lecture The content of today's lecture felt relevant based on my own experiences It was helpful to be able to share my experiences with other participants It was helpful to take part of others experiences and tips on strategies |
Immediately after intervention | |
Primary | Study 1: Evaluation after session 2 | This includes five items scored on a Likert scale ranging from 0 ("not at all") to 4 ("yes, absolutely"), with item one to three concerning the participants opinion of the content and knowledge acquired and item four to five whether it was useful to trade experiences with the other participants.
Intervention satisfaction was measured with an evaluation questionnaire after each session, a modified version Session evaluation form (SEF: Bramham et al., 2009; Hirvikoski et al., 2017). High values are indication of statisfaction: After today's lecture, my knowledge about ASD has increased I will benefit from what we went through on today's lecture The content of today's lecture felt relevant based on my own experiences It was helpful to be able to share my experiences with other participants It was helpful to take part of others experiences and tips on strategies |
Immediately after intervention | |
Primary | Study 1: Evaluation after session 3 | This includes five items scored on a Likert scale ranging from 0 ("not at all") to 4 ("yes, absolutely"), with item one to three concerning the participants opinion of the content and knowledge acquired and item four to five whether it was useful to trade experiences with the other participants.
Intervention satisfaction was measured with an evaluation questionnaire after each session, a modified version of the Session evaluation form (SEF: Bramham et al., 2009; Hirvikoski et al., 2017). High values are indication of statisfaction: After today's lecture, my knowledge about ASD has increased I will benefit from what we went through on today's lecture The content of today's lecture felt relevant based on my own experiences It was helpful to be able to share my experiences with other participants It was helpful to take part of others experiences and tips on strategies |
Immediately after intervention | |
Primary | Study 1: Evaluation after session 4 | This includes five items scored on a Likert scale ranging from 0 ("not at all") to 4 ("yes, absolutely"), with item one to three concerning the participants opinion of the content and knowledge acquired and item four to five whether it was useful to trade experiences with the other participants.
Intervention satisfaction was measured with an evaluation questionnaire after each session, a modified version of the Session evaluation form (SEF: Bramham et al., 2009; Hirvikoski et al., 2017). High values are indication of statisfaction: After today's lecture, my knowledge about ASD has increased I will benefit from what we went through on today's lecture The content of today's lecture felt relevant based on my own experiences It was helpful to be able to share my experiences with other participants It was helpful to take part of others experiences and tips on strategies |
Immediately after intervention | |
Primary | Study 1: Number of individuals that completed the intervention | To have competed the interevention was measured as attending =3 out of 4 sessions | Immediately after intervention | |
Primary | Study 1: Adverse events during the intervention | (reports of inconvenience or hospitalization due to the intervention) | Through completion of the intervention (typically within 4 weeks) | |
Primary | Study 1: Adverse events after the intervention | (reports of inconvenience or hospitalization due to the intervention) | Immediately after intervention | |
Primary | Study 1: Overall treatment satisfaction measured by The Evaluation Questionnaire | The participants (both ASD patient and significant other) also filled out an evaluation form after the last session, a modified version of the Evaluation Questionnaire (Hesslinger et al., 2002; Hirvikoski et al., 2011), about their overall appraisal of the intervention. Higher values are indication of satisfaction. 12 items and was distributed at the end of the last session. Five items regarding the content of the intervention as a whole (i.e. all four group sessions) were scored on a Likert scale ranging from 0-4 (0=not at all, 4= yes, absolutely). ("The content of the intervention has clearly been ASC-related", "My knowledge about ASC has increased", "I am more able to cope with my ASC-related problems", "During the sessions I have been able to give my point of views", "I would attend similar intervention again").The participants also rated the course as a whole following the school grading system ''Failed,'' ''Passed,'' ''Passed with distinction,'' and ''Passed with special | Immediately after intervention | |
Primary | Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire | The participants (patient with ASD and signifcant other) filled out an evaluation form after the last session, a modified version of the Evaluation Questionnaire (Hesslinger et al., 2002; Hirvikoski et al., 2011), about their overall appraisal of the intervention. Higher values are indication of satisfaction. 12 items and was distributed at the end of the last session. Beyond the five items mentioned above, the participants could answer four questions with open answers ("How has the intervention been helpful?", "What could be done to improve the intervention?", "Could you have done anything different?", "Is there anything else you would like to comment?") | Immediately after intervention | |
Primary | Study 1: Well-beining before and after the intervention measures by The Evaluation Questionnaire | The participants filled out an evaluation form after the last session, a modified version of the Evaluation Questionnaire (Hesslinger et al., 2002; Hirvikoski et al., 2011), about their overall appraisal of the intervention. Since it is of great importance to follow-up the participants well-being, the form contained two items where the participants rated their well-being before and after the intervention ("How would you rate your well-being prior to the intervention?", "How would you rate your current well-being") at T1 and T2 on a scale 1-10 (1= very poor, 10= very good). They could also rate the intervention as whole; answering if they considered it to be "Not approved", "Approved", "Well Approved" or "Very well Approved". | Immediately after intervention | |
Primary | Study 1: Credibility measured with the Credibility Scale (TCS: Borkovec & Nau, 1972) | Five items: four items that measure treatment credibility and one outcome expectation. Items scored on a 10-point. Likert scale, with a total score range of 0-50. High values = high credibility. | Immediately after intervention | |
Primary | Study 2: Knowledge about autism measured by Autism specific quiz | ASD knowledge was measured using the ASD 20 Questions, a knowledge quiz with 20 true/false/don't know scored items, reflecting knowledge about ASD, which was modified for this study (Bramham et al. 2009; Hirvikoski et al 2017). Total score range from 0-20. High values = more knowledge | Change in knowledge from baseline to immediately after the intervention and at three month follow-up | |
Primary | Study 3: Participation measured by Patient Participation in Rehabilitation Questionnaire. | Active participation during the intervention will be measured with Patient Participation in Rehabilitation Questionnaire (PPRQ: Lindberg et al., 2013). The scale consists of 23 items that are rated on 5 step likert scale. High values = active participation. | Change in knowledge from baseline to immediately after the intervention. | |
Primary | Study 3: Patient Stigma | Does PRISMA lead to reduced self-stigma for the adult with ASD and/or reduced affiliate stigma for the significant other? The scales we plan to use in study 3 are Internalized Stigma of mental Illness (ISMI) scale (Boyd, Adler, Otilingam & Peters, 2014). The scale consists of 29 items on a 4 step likert scale. High values = more stigma | Change from baseline to immediately after the intervention | |
Primary | Study 3: Affiliate Stigma | To measure stigma in significant others, we will use Affiliate Stigma scale. This scale is new but show good psychometric properties (Mak & Cheung, 2008). The scale consists of 22 items on a 4 step likert scale. High values = more stigma | Change from baseline to immediately after the intervention | |
Secondary | All studies: Quality of life: Satisfaction with life scale (SWLS) | Quality of life is measured with Satisfaction with life scale (SWLS) Pavot & Diener, 1993.
Its five items are scored on a scale from 1 to 7, indicating very dissatisfied to very satisfied, with 4 as a neutral point. |
Change from baseline to immediately after the intervention and at three month follow-up | |
Secondary | All studies: Acceptance of diagnosis measured with "What I think about my diagnosis" | What I think about my diagnosis" for patients with ASD and "What I think about my significant other diagnosis" for significant others. Both questionnaires with 7 items scored on a 7-point likert-scale raging from 1 to 7, "Always true" to "Never true" (Hirvikoski et al, 2017) and based on Acceptance and Action Questionnaire - II (Hayes et al, 2001). | Change from baseline to immediately after the intervention and at three month follow-up | |
Secondary | All studies: Well-being with Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (A. S. Zigmond & Snaith, 1983) was used to measure well-being on the two subscales Depression and Anxiety containing seven items each, and scored on a 0-3 Likert-scale. | Change from baseline to immediately after the intervention and at three month follow-up | |
Secondary | Study 1 and 2: The burden of care on significant others measured with Assessment Scale (BAS) | The burden of care on significant others was assessed using the Burden Assessment Scale (BAS) (Reinhard et al. 1994), a scale consisting of 19 items scored on a 4-point Likert scale from 1 ("Not at all") to 4 ("A lot"). | Change from baseline to immediately after the intervention and at three month follow-up | |
Secondary | Study 1 and 2: Relation to significant others (QAFM) | The Questions About Family Members (QAFM) (Hansson and Jarbin 1997) constitute a dyadic self-report questionnaire, which was used to measure aspects of the quality of the relationship between the co-participants, i.e., the relationship between the adult individual with ASD and his/her significant other(s). The QAFM comprises four subscales: (1) Critical Remarks (directed at the other person); (2) (the respondent's) Emotional Over-involvement; (3) Perceived Criticism (from the other person); and (4) (perceived) Emotional Involvement (from the other person in the relationship). The 30 items are scored on a 1 ("almost never") to 5 ("almost always") Likert scale. Low scores on the first three subscales are indicative of a good quality of relationship, while on the last subscale (Emotional Involvement), high scores indicate the same. | Change from baseline to immediately after the intervention and at three month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |