Cargando…

Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability

PURPOSE: To explore, from the perspective of Study Partners (SPs; eg, caregivers) of clinical trial participants with autism spectrum disorder (ASD), any changes experienced in socialization and communication over the clinical trial, how these changes manifested, and the impact these changes had on...

Descripción completa

Detalles Bibliográficos
Autores principales: Chladek, Michael, Burbridge, Claire, Gibbons, Elizabeth, Willgoss, Tom, Smith, Janice, Clinch, Susanne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676099/
https://www.ncbi.nlm.nih.gov/pubmed/38027417
http://dx.doi.org/10.2147/PROM.S385682
_version_ 1785149907936477184
author Chladek, Michael
Burbridge, Claire
Gibbons, Elizabeth
Willgoss, Tom
Smith, Janice
Clinch, Susanne
author_facet Chladek, Michael
Burbridge, Claire
Gibbons, Elizabeth
Willgoss, Tom
Smith, Janice
Clinch, Susanne
author_sort Chladek, Michael
collection PubMed
description PURPOSE: To explore, from the perspective of Study Partners (SPs; eg, caregivers) of clinical trial participants with autism spectrum disorder (ASD), any changes experienced in socialization and communication over the clinical trial, how these changes manifested, and the impact these changes had on the autistic individual, the SP, and family. This helps interpret whether changes in trial outcomes were meaningful. PATIENTS AND METHODS: Interviews were conducted with the SPs of individuals with ASD, without intellectual disability, from 2 clinical trials: 86 children (aged 5–12 years) or adolescents (aged 13–17 years) who took part in the aV1ation trial (83.7% male), and 41 adults (aged 18+ years) who took part in the V1aduct trial (80.5% male). The primary endpoint for both trials was change from baseline in the Vineland(TM)-II two-domain composite, consisting of the mean of the Socialization and Communication domains. In these interviews the participants verbally indicated level of change for each of these key domains on 7-point change scales. RESULTS: Improvements in the Socialization domain enabled greater awareness of the feelings of others and allowed for stronger empathy and kindness. Improvements in the Communication domain allowed for the autistic individual to be better at listening and better at self-expression. Together, changes in these two domains, which were considered most important, allowed for richer, deeper relationships. Study Partners noted that improvements in these domains allowed for better integration within the family unit, decreased stress, and increased optimism about the autistic individual’s future. CONCLUSIONS: The impacts of changes in either domain were synergistic, combining together to create positive experiences which in turn led to further positive impacts in other skills. These qualitative insights provide context to the changes that were observed during the clinical trial and captured using the Vineland(TM)-II, illustrating the meaning of these changes to the individuals with ASD without intellectual disability and their families, and the impact that they have on people’s everyday lives and overall health-related quality of life.
format Online
Article
Text
id pubmed-10676099
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Dove
record_format MEDLINE/PubMed
spelling pubmed-106760992023-11-21 Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability Chladek, Michael Burbridge, Claire Gibbons, Elizabeth Willgoss, Tom Smith, Janice Clinch, Susanne Patient Relat Outcome Meas Original Research PURPOSE: To explore, from the perspective of Study Partners (SPs; eg, caregivers) of clinical trial participants with autism spectrum disorder (ASD), any changes experienced in socialization and communication over the clinical trial, how these changes manifested, and the impact these changes had on the autistic individual, the SP, and family. This helps interpret whether changes in trial outcomes were meaningful. PATIENTS AND METHODS: Interviews were conducted with the SPs of individuals with ASD, without intellectual disability, from 2 clinical trials: 86 children (aged 5–12 years) or adolescents (aged 13–17 years) who took part in the aV1ation trial (83.7% male), and 41 adults (aged 18+ years) who took part in the V1aduct trial (80.5% male). The primary endpoint for both trials was change from baseline in the Vineland(TM)-II two-domain composite, consisting of the mean of the Socialization and Communication domains. In these interviews the participants verbally indicated level of change for each of these key domains on 7-point change scales. RESULTS: Improvements in the Socialization domain enabled greater awareness of the feelings of others and allowed for stronger empathy and kindness. Improvements in the Communication domain allowed for the autistic individual to be better at listening and better at self-expression. Together, changes in these two domains, which were considered most important, allowed for richer, deeper relationships. Study Partners noted that improvements in these domains allowed for better integration within the family unit, decreased stress, and increased optimism about the autistic individual’s future. CONCLUSIONS: The impacts of changes in either domain were synergistic, combining together to create positive experiences which in turn led to further positive impacts in other skills. These qualitative insights provide context to the changes that were observed during the clinical trial and captured using the Vineland(TM)-II, illustrating the meaning of these changes to the individuals with ASD without intellectual disability and their families, and the impact that they have on people’s everyday lives and overall health-related quality of life. Dove 2023-11-21 /pmc/articles/PMC10676099/ /pubmed/38027417 http://dx.doi.org/10.2147/PROM.S385682 Text en © 2023 Chladek et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
spellingShingle Original Research
Chladek, Michael
Burbridge, Claire
Gibbons, Elizabeth
Willgoss, Tom
Smith, Janice
Clinch, Susanne
Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title_full Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title_fullStr Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title_full_unstemmed Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title_short Qualitative Exploration in Exit Interviews of Changes Observed in Clinical Trials for Individuals with Autism Spectrum Disorder Without Intellectual Disability
title_sort qualitative exploration in exit interviews of changes observed in clinical trials for individuals with autism spectrum disorder without intellectual disability
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10676099/
https://www.ncbi.nlm.nih.gov/pubmed/38027417
http://dx.doi.org/10.2147/PROM.S385682
work_keys_str_mv AT chladekmichael qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability
AT burbridgeclaire qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability
AT gibbonselizabeth qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability
AT willgosstom qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability
AT smithjanice qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability
AT clinchsusanne qualitativeexplorationinexitinterviewsofchangesobservedinclinicaltrialsforindividualswithautismspectrumdisorderwithoutintellectualdisability