Psychoeducation for Adults With Autism and Their Significant Others/Family Members
NCT ID: NCT04460976
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
718 participants
INTERVENTIONAL
2017-09-01
2020-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
Experiment group that receives the psychoeducation direct after the baseline measurement.
Psychoeducation for Adults With Autism and Their Significant Others/Family members (Prisma)
Psychoeducation in groups
Control group
Standard care / treatment as usual. Comparison group alos receives Prisma psychoeducation after the three-month follow-up time period.
Treatment as usual/standard care
Standard care at disability/habilitation services.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tatja Hirvikoski
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karolinska Institutet
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Prisma
Identifier Type: -
Identifier Source: org_study_id