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

NCT04460976 | Completed

• 1 other identifier: Prisma
• Study Type: interventional
• Target: 718
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Autism; Psychoeducation; Adults; Significant others; Knowledge acquisition; Stigma

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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)

• Study 1: Adverse events after the intervention

  (reports of inconvenience or hospitalization due to the intervention)

  Immediately after intervention

• 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

• 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

• 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

• 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

• 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

• 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.

• 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

• 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 Outcomes (5)

• All studies: Quality of life: Satisfaction with life scale (SWLS)

  Change from baseline to immediately after the intervention and at three month follow-up

• All studies: Acceptance of diagnosis measured with "What I think about my diagnosis"

  Change from baseline to immediately after the intervention and at three month follow-up

• All studies: Well-being with Hospital Anxiety and Depression Scale (HADS)

  Change from baseline to immediately after the intervention and at three month follow-up

• Study 1 and 2: The burden of care on significant others measured with Assessment Scale (BAS)

  Change from baseline to immediately after the intervention and at three month follow-up

• Study 1 and 2: Relation to significant others (QAFM)

  Change from baseline to immediately after the intervention and at three month follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

Experiment group that receives the psychoeducation direct after the baseline measurement.

Behavioral: Psychoeducation for Adults With Autism and Their Significant Others/Family members (Prisma)

Control group

OTHER

Standard care / treatment as usual. Comparison group alos receives Prisma psychoeducation after the three-month follow-up time period.

Behavioral: Treatment as usual/standard care

Interventions

Psychoeducation for Adults With Autism and Their Significant Others/Family members (Prisma) BEHAVIORAL

Psychoeducation in groups

Experimental group

Treatment as usual/standard care BEHAVIORAL

Standard care at disability/habilitation services.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Autistic Disorder; Social Stigma

Interventions

mesoglycan; Therapeutics; Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Social Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking at baseline of both participant and care-provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: July 8, 2020
• Study Start: September 1, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

SE (1)