Psychoeducation for Adults With Autism and Their Significant Others/Family Members

Depression Clinical Trial

— Prisma  

Official title:

Psychoeducation for Adults With Autism and Their Significant Others/Family Members

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460976
• Other study ID #: Prisma
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 15, 2020

Study information

• Verified date: December 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Against the background that interest organizations has identified a need for more knowledge about ASD both in adults with ASD and their significant others, a psychoeducational intervention Prisma was created. Prisma - the psychoeducational intervention The intervention consists of four 2-hour sessions (2 x 45 min lecture plus paus and time for questions). Two clinicians administer each course and follow a power point with detailed instructions. The goal is to increase knowledge and provide the participants with new insights into their diagnosis and that they get concrete tools that will help them handle obstacles in their everyday life. Another important aspect is to learn more about available support and services. This research project consists of three studies: An open feasibility study , a randomized controlled trail (RCT) including a three month follow-up, a moderation and mediation study including new outcome variables for stigma and participation. Study 1. The data collection for the open feasibility study was carried out during the fall of 2017. Data remains to be analyzed. n = 186 Study 2. The RCT will include approximately n=80 in the experimental group and equally many wait-list controls. The RCT also include one significant other per patient which gives a total number of 320 in the RCT. Participants are randomized to be in either the experimental group or the wait-list/treatment as usual controls. The experimental groups receive Prisma according to the manual while the wait-list/TAU controls take part in Prisma approximately 4 months later. Study 3. In order to expand the analyses beyond what is addressed in the RCT (study 2), researchers would like to investigate if increased knowledge of ASD via participation in Prisma will affect self-stigma and/or affiliate stigma. Importantly, stigma will be investigated both in adults with ASD (self-stigma) and in their significant others (affiliate stigma). Yet another expansion of this project that researchers will address in study 3 is the experiences of active participation and engagement during the Prisma program, and possible association between engagement and treatment results for the adults with ASD and their significant others.This study will include 150 adults with ASD and 150 significant others.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acceptance of Diagnosis
• Anxiety
• Depression
• Knowledge Acquisition Disability Nos
• Mental Disorders
• Participation
• Quality of Life
• Relation, Family
• Stigma of Mental Illness
• Treatment Satisfaction

Intervention

Behavioral:
• Psychoeducation for Adults With Autism and Their Significant Others/Family members (Prisma)
Psychoeducation in groups
• Treatment as usual/standard care
Standard care at disability/habilitation services.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

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