The goal of the current observational multicenter pilot study is to investigate if an 8-week Acceptance and Commitment group therapy for youth with ASD is an effective intervention to increase adaptive emotion regulation, psychological flexibility…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The goal of the current observational multicenter pilot study is to investigate
if an 8-week Acceptance and Commitment group therapy for youth with ASD is an
effective intervention to increase adaptive emotion regulation, psychological
flexibility and quality of life. For this we have selected several parameters
which are suitable for multiple measurements due to brevity and ease
(multilevel single case (MSC) design, whilst other parameters are most suitable
for pre-post-follow up design to provide more comprehensive insights into the
functioning of the participants and the effects of the intervention
(pre-post-follow up design).
Primary Objectives:
To assess
- Emotion regulation -->
o FEEL-KJ (Braet et al., 2013) (pre-post-follow up)
o Valuing Questionaire (VQ) (Smout, 2014) (pre-post-follow up and MSC)
- Psychological flexibility -->
o Avoidance and Fusion Questionnaire for Youth (AFQ-Y) (Greco et al., 2008)
(pre-post-follow up)
o Valuing Questionaire (VQ) (Smout, 2014) (pre-post-follow up and MSC)
- Quality of life -->
o Mental Health Quality of Life (MHQoL) (van Krugten et al., 2022)
(pre-post-follow up and MSC)
Secondary outcome
Secondary Objective(s):
In addition, we want to investigate if the treatment has any effect on
emotional and behavioral problems and general functioning (e.g., attending
school or not; utilization of other (mental) healthcare).
To assess:
- Emotional and behavioral problems -->
o Youth/Adult Self Report (YSR/ASR) and Child Behavior Checklist (CBCL;
ASEBA,(Verhulst et al., 1989, 1996) (pre-post-follow up)
- Demographic questions -->
o School attendance (pre-post-follow up)
o Utilization of (mental) healthcare (pre-post-follow up)
Lastly, we will use some information for baseline/comparison to ROM data and/or
elements which may be influential on our measurements or potential desired
side-products:
- Autistic traits -->
o Social Responsiveness Scale (SRS-2/SRS-A) (not expected to change, but
possibly an influential factor on the success of the intervention) (Roeyers et
al., 2011)
- Current feeling (start of session) -->
o Visual Analogue Scale (VAS; not expected to change but a potentially
influential factor on our outcome measures and a potential by-product of the
intervention).
Background summary
Evidence-based treatment for adolescents with autism spectrum disorders (ASD)
and comorbid issues such as high levels of anxiety, depression, and persistent
physical complaints is scarce. Mental health care professionals seek fitting
and effective treatments. Acceptance and Commitment Therapy (ACT) seems to be a
promising method, which aims to teach individuals how to cope with complaints
(rather than trying to diminish or fight complaints) and develop a meaningful
life. However, this form of therapy has not been studied in autistic youth
before, therefore making it unclear if ACT could be an effective intervention.
Study objective
The goal of the current observational multicenter pilot study is to investigate
if an 8-week Acceptance and Commitment group therapy for youth with ASD is an
effective intervention to increase adaptive emotion regulation, psychological
flexibility and quality of life? We aim to see if there are effects on a group
level from pre-intervention to post intervention, as well as at 6-months
follow-up (pre-post-follow-up design). Moreover, we will also investigate if
there are effects on an individual level from pre, to during, to after the
intervention (multilevel single case design).
Study design
This study will be a multicenter pilot study with a pre-post-follow up and
multilevel single case design. In the pre-post-follow up arm participants will
fill out a long survey (approx. 45 minutes) 3 times (prior, after and at 6
months follow-up), whilst in the multilevel single case arm participants will
fill out a weekly short survey (approx. 5 minutes) from 4 weeks prior to 4
weeks after the last session of the intervention (1st and last week of these
measurements are included in the long survey to reduce burden on participants).
Intervention
Before the first session, an individual intake takes place to set personal
goals. The ACT group for adolescents with ASD is an 8-week protocol developed
specifically for adolescents with ASD. They join a group treatment covering the
six ACT core principles (Present moment, Acceptance, Defusion, Self as Context,
Values, Committed Action). After the 8 group sessions, in an individual closing
meeting, the goals are evaluated with the adolescent. Two booster sessions are
used to repeat the essentials of the theory and exercises and to let the
adolescents practice using ACT skills when running into challenging situations
in their daily life. After the 4th group session, there will be a parent
session to also provide the parents with information on ACT; suggestions on how
they may support their child by means of ACT, and connection with other parents
of autistic children.
Study burden and risks
The participants will take part in a group treatment which can be considered as
care-as-usual, including the booster sessions, as similar care (i.e., group
therapy, with a different method, for example psycho-education or music
therapy) is already offered at the clinical locations. Different from the
care-as-usual, is that participants are asked to fill out a weekly short survey
from 4 week prior to treatment to 4 weeks after treatment (16 * 5 min) and 3
times the longer survey prior to treatment, directly after treatment and 6
months after treatment (3 * 45 min). The 1st and last week of the short
measurements are included in the long survey to reduce burden on participants.
The filing out of questionnaires should then total to a maximum of 215 minutes
(i.e., just over 3.5 hours over the span of 10 months). In addition, the
parents of the participants will fill out a survey on child emotional and
behavioral problems prior and after treatment (2 * 45 min) and attend a
parent-session after the 4th group session (45 min).
The time spent may be a burden on the participants and their parents. We have
tried to minimize the time spent to reduce the burden, whilst upholding the
integrity of the study. Given that the participants can fill out the weekly
surveys at their session in no more than 5 minutes, this can be considered part
of the treatment as it is integral in the session. In addition, the 1st and
last week of the MSC measurements are included in the long survey to reduce
burden on participants.
As we intend to investigate the feasibility and efficacy of a new treatment in
autistic youth, it is necessary to collect data in this group. By doing this in
the current design (the pre-post design combined with the multi-level single
case design), we will get rich data which will allow us to analyze the effects
in-depth, so we can more accurately estimate potential efficacy, identify who
may benefit most, and which sessions may be most beneficial whilst having a
limited number of participants. Other than the time investment, we believe
there are no other burdens or risks to participating in the study as the
intervention can be seen as care-as-usual. In addition, the time spent is
spread out of 10 months.
Burgemeester Oudlaan 50
Rotterdam 3062PA
NL
Burgemeester Oudlaan 50
Rotterdam 3062PA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are age between 12 and 21 (given child and adolescent
healthcare age cut-offs), being referred to one of the participating mental
health institutions, and a primary classification of ASD for the youth
participants. Also, we ask the parents of the participants to fill out 2
questionnaires (pre and post) and to participate in a parent-session (care as
usual)
Exclusion criteria
Exclusion criteria: insufficient knowledge of the Dutch language, acute suicide
risk, drug abuse, and an estimated total IQ below 80.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL86185.078.24 |