The main objective of the study is to investigate whether an 8 week MFT for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) or Autism Spectrum Disorder (ASD) as well as an 8 week MPT for parents, would be effective in…
ID
Source
Brief title
Condition
- Other condition
- Psychiatric and behavioural symptoms NEC
Synonym
Health condition
Attention Deficit Hyperactivity Disorder + Autism Spectrum Disorder
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measure for study populations 1, 2, 3, 4 and 5 is attention
problems.
Secondary outcome
Secondary outcome measures are anxiety and depression symptoms, stress,
fatigue, quality of life, family emotion regulation, and mindfulness for study
population 1, 2, 3, 4 and 5. Population specific outcome measures are
hyperactivity and impulsivity in study populations 1 and 2; rumination and
problems in social interaction and communication in study population 3 and 4;
and self-compassion, acceptence and experiential avoidance in study population
5.
Background summary
Although the effects of Mindfulness Training (MFT) in adults are well
established, research on the effects of MFT in child and adolescent psychiatry
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 be effective in children and adolescents
with ADHD and ASD. Also for Mindful Parenting Training (MPT) it is hypothesized
it will have positive effects on both parent and child.
Study objective
The main objective of the study is to investigate whether an 8 week MFT for
children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD)
or Autism Spectrum Disorder (ASD) as well as an 8 week MPT for parents, would
be effective in reducing psychiatric symptoms and increasing mindfulness.
Study design
A non-experimental pre-post design with two follow-up measurements will be
used, with a within group waitlist condition to control for time effects.
A multi-informants design is used, with subjective as well as objective
measurements. Measurement occasions will be at waitlist (8 weeks prior to
training), pre-training (1 week prior to training), post-training (directly
after training), and at two follow-up occasions (8 weeks and 1 year after
post-training).
Intervention
Subjects from study population 1, 2, 3 and 4 receive MFT that consists of 8
weekly 1.5 hour group sessions. During the MFT of study population 1, 2, 3 and
4, parents receive 8 weeks parallel MPT (pMPT). Subjects from study population
5 are parents who join the MPT without their children. They attend the 8 weeks
3 hour group sessions.
Study burden and risks
Subjects of populations 1, 2, 3 and 4 participate in MFT, which consists of 8
weekly 1.5 hour group sessions. Their parents follow pMPT which also consist of
8 weekly 1.5 hour group sessions. Subject of population 5 participate in 8
weekly 3 hour sessions of MPT.
Children and adolescents need to spend an additional 15 minutes daily on their
homework, whereas parents need to spend an additional 30 minutes each day. The
burden is considered minimal, as our clinical impressions as well as
standardized evaluation forms indicate that the meditation brings them
quietness, that the yoga exercises are fun to do, and the time they need to
spend is considered reasonable. Often patients are very motivated for this
training, as mindfulness enables them to do something about their attention
problems, anxiety and depressive symptoms themselves, without the use of
medication. Compliance to the MFT as well as response rate at the different
measurement occasions is very high. The questionnaires can be completed online,
so participants can do it in the comfort of their home environment. Only for
the computer task the child/adolescent needs to come to the treatment center.
Participation in mindfulness training carries no risks.
The Mindfulness research lines as described in this study have been evaluated
and approved by the Ethical Committee of the Department of Child Development
and Education, Faculty of Social and Behavioral Sciences, University of
Amsterdam.
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Nieuwe Prinsengracht 130
Amsterdam 1018 VZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;For study populations 1 and 2:
Inclusion criteria for the ADHD group are (1) a DSM-IV diagnosis of ADHD established with the parent and child version of the Anxiety Disorders Interview Schedule for Children (ADIS-C), (2) an estimated IQ of 80 or higher, (3) participants have to be able to attend the first session, with a minimum of at least 6 out of 8 sessions, and (4), at least one parent has to be able to attend the parent sessions and (5), participants have to be between 9 and 12 years old (elementary school) for the children group and between 12 and 18 years old (secondary school) for the adolescent group. ;For study population 3 and 4:
Inclusion criteria for the ASD group are (1) a DSM-IV diagnosis of ASD confirmed by the Autism Diagnostic Observation Schedule - Generic (ADOS-G), (2) an estimated IQ of 80 or higher, (3) participants have to be able to attend the first session, with a minimum of at least 6 out of 8 sessions, and (4), at least one parent has to be able to attend the parent sessions, and (5), participants have to be between 9 and 12 years old (elementary school) for the children group and between 12 and 23 years old (secondary school and beyond) for the adolescent group.;For study population 5:
Inclusion criteria for the MPT are (1) the experience of childrearing stress, (2) either a DSM-IV diagnosis of the parent or the child, (3) an estimated IQ of 80 or higher, and (4), participants have to be able to attend the first session, with a minimum of at least 6 out of 8 sessions.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;For study populations 1 and 2:
Participants are excluded from participation when (1) inadequate mastery of the Dutch language by the child or parents, (2) severe behavioral problems established by a CD on the ADIS-C, (3) comorbid developmental disorder (autistic), and (4), participating in another ongoing psychological intervention (apart from *stable* medication). ;For study population 3 and 4:
Participants are excluded from participation when (1) inadequate mastery of the Dutch language by the child or parents, (2) severe behavioral problems established by the ADIS-C, (3) presence of suicidal risk, (4) presence of non-treated psychotic disorders, and (5), participating in another ongoing psychological intervention (apart from *stable* medication). ;For study population 5:
Participants are excluded from participation when (1) inadequate mastery of the Dutch language and (2), participating in another ongoing psychological intervention (apart from *stable* medication).
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 | NL43720.018.13 |