Clinical trial NCT04460976: Psychoeducation for Adults With Autism and Their Significant Others/Family Members
Official title: Psychoeducation for Adults With Autism and Their Significant Others/Family Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2020-07-08
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study 1: Evaluation of session 1
timeFrame: Immediately after intervention
measure: Study 1: Evaluation after session 2
timeFrame: Immediately after intervention
measure: Study 1: Evaluation after session 3
timeFrame: Immediately after intervention
measure: Study 1: Evaluation after session 4
timeFrame: Immediately after intervention
measure: Study 1: Number of individuals that completed the intervention
timeFrame: Immediately after intervention
measure: Study 1: Adverse events during the intervention
timeFrame: Through completion of the intervention (typically within 4 weeks)
measure: Study 1: Adverse events after the intervention
timeFrame: Immediately after intervention
measure: Study 1: Overall treatment satisfaction measured by The Evaluation Questionnaire
timeFrame: Immediately after intervention
measure: Study 1: Open answer questions regarding Treatment satisfaction measured by The Evaluation Questionnaire
timeFrame: Immediately after intervention
measure: Study 1: Well-beining before and after the intervention measures by The Evaluation Questionnaire
timeFrame: Immediately after intervention
measure: Study 1: Credibility measured with the Credibility Scale (TCS: Borkovec & Nau, 1972)
timeFrame: Immediately after intervention
measure: Study 2: Knowledge about autism measured by Autism specific quiz
timeFrame: Change in knowledge from baseline to immediately after the intervention and at three month follow-up
measure: Study 3: Participation measured by Patient Participation in Rehabilitation Questionnaire.
timeFrame: Change in knowledge from baseline to immediately after the intervention.
measure: Study 3: Patient Stigma
timeFrame: Change from baseline to immediately after the intervention
measure: Study 3: Affiliate Stigma
timeFrame: Change from baseline to immediately after the intervention
Secondary outcomes:
measure: All studies: Quality of life: Satisfaction with life scale (SWLS)
timeFrame: Change from baseline to immediately after the intervention and at three month follow-up
measure: All studies: Acceptance of diagnosis measured with "What I think about my diagnosis"
timeFrame: Change from baseline to immediately after the intervention and at three month follow-up
measure: All studies: Well-being with Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline to immediately after the intervention and at three month follow-up
measure: Study 1 and 2: The burden of care on significant others measured with Assessment Scale (BAS)
timeFrame: Change from baseline to immediately after the intervention and at three month follow-up
measure: Study 1 and 2: Relation to significant others (QAFM)
timeFrame: Change from baseline to immediately after the intervention and at three month follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: