The main objective of the study is to investigate whether a 9 week MFT for adolescents with ASD and clinically elevated internalizing symptoms, reduces adolescent's internalizing symptoms. Secondary objective is to investigate the process of…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
Autisme spectrum stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Individualized daily measures of internalizing symptoms are the primary outcome
measures.
Secondary outcome
Secondary outcome measures are daily reported process variables: time spent on
formal mindfulness practices, mindful awareness, worry, rumination, stress,
compassion, self-compassion, and sleep. A multi-informant design is used, with
subjects and their parents as informants. Daily measures will be completed
during baseline period, training, follow-up till 9 weeks after training, and 1
year follow-up during 1 week. Additional measurement occasions will be
pre-training (just before training), post-training (directly after training),
and at two follow-up occasions (9 weeks and 1 year after training).
Background summary
Although the effects of Mindfulness Training (MFT) in adults are well
established, research on the effects of MFT in adolescents with Autism Spectrum
Disorder (ASD) is a relatively new domain. Based on proven effectiveness in
adults as well as promising results from pilot studies in children and
adolescents, it is hypothesized that the use of MFT will have positive effects
for adolescents with ASD and clinically elevated internalizing symptoms.
Study objective
The main objective of the study is to investigate whether a 9 week MFT for
adolescents with ASD and clinically elevated internalizing symptoms, reduces
adolescent's internalizing symptoms. Secondary objective is to investigate the
process of change.
Study design
A single case experimental design with a multiple baseline across subjects will
be used to investigate how changes unfold over time. In addition, pre-training,
post-training, and follow-up measures will be conducted.
Intervention
Subjects receive MFT that consists of 9 weekly 1.5 hour individual sessions.
Their parents receive one session Mindful Parenting Training (MPT) and will
take part in the last session and the booster session with their child for 30
minutes.
Study burden and risks
Daily measures will be completed during baseline period, training, follow-up
till 9 weeks after training, and 1 year follow-up during 2 weeks. This is
between 147 and 168 days in total. The daily measures will last three minutes
per day, which is considered feasible to fill in every day for adolescents and
their parents. Participants could benefit from getting insight in their daily
functioning and the effect of MFT on their personal goals by completing the
daily measures. Additional measurement occasions will be at 4 occasions:
pre-training (before start training), post-training (directly after training),
and at two follow-up occasions (9 weeks and 1 year after training), and last 40
to 50 minutes each time. The questionnaires can be completed online, so
participants can do it in the comfort of their home environment. The
information provided by the questionnaires and daily measures are essential for
investigating the effectts of MFT for this target group. Participation in this
study carries no risks. This study can only be carried out with including
adolescents between 14 and 17 years old next to adolescents aged 18 till 21
years old, because the MFT protocol is developed for the developmental phase of
adolescence, which starts after 11 years and lasts into young adulthood.
Children between 14 and 17 years old in early and middle adolescence could
benefit from the MFT protocol, but evidence for the effects of the MFT training
can only be provided if this group is included in this study investigating the
protocol. A related research protocol that included the same population and MFT
has been evaluated and approved by the Medical Ethical Committee of the
Academical Medical Centre (AMC), project number NL43720.018.13.
Nieuwe Achtergracht 127
Amsterdam 1018WS
NL
Nieuwe Achtergracht 127
Amsterdam 1018WS
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are (1) a DSM diagnosis of ASD verified by the Autism Diagnostic Observation Schedule - Generic (ADOS-G), (2) clinically elevated internalizing symptoms as verified by at least one internalizing diagnosis on a semi-structured diagnostic interview (e.g. Anxiety Disorders Interview Schedule, ADIS), and a (sub) clinical score on CBCL and YSR internalizing problems; (3) an estimated IQ of 80 or higher, (3) adolescents have to be between 14 and 21 years old.
Exclusion criteria
Participants are excluded from participation when (1) inadequate mastery of the language in which the training is conducted by the child or parents, (2) severe behavioral problems established by a conduct disorder (CD) on the ADIS-C, (3) presence of current suicidal risk, (4) presence of current non-treated psychotic disorders, (5), participating in another ongoing psychological intervention (apart from *stable* medication), and (6) living away from family home.
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 | NL54211.018.15 |