We aim to evaluate the effectiveness of the Dutch translation and cultural adaptation of PEERS program in a randomized controlled trial (RCT) using an active treatment control group and a blinded observation of social competence as outcome measure.…
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Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is social competence as assessed using a blinded
observation measure: the Contextual Assessment of Social Skills (CASS);
Secondary outcome
The secundary study parameters are the questionnaires filled out parents,
teachers and the adolescent. These form the replication part of the study:
1. social skills questionnaire reported by the adolescents self, the parent and
the teacher: Social Skills Improvement System-Rating Skills (SSIS-RS);
2. a questionnaire assessing autistic social impairment reported by parent and
teacher: Social Responsive Scale (SRS).
In addition, we will assess hypothesized mediators of the effect on social
competence:
1. social contacts of the participants assessed using the Quality of
Socialization Questionnaire (QSQ);
2. social knowledge among adolescents assessed using the Test of Adolescents
Social Skills Knowledge (TASSK);
3. social cognition of adolescents as assessed using the Test of Understanding
of Social Conventions (TUSC);
4. fear of social rejection scored by participants using Brief Fear of Negative
Evaluation-II scale (BFNE-II);
5. parent*s satisfaction with parenting and self-efficacy in the parenting
role assessed using the Parenting Sense of Competence Scale (PSOC);
as well as potential moderators of the treatment effect:
1. severity of ASD, assessed using the Autism Diagnostic Observation Schedule
(ADOS) and 3Di;
2. IQ, from patient file or measured by the Wechsler Abbreviated Scale
of Intelligence (WASI);
3. emotional and behavioral problems, measured using the Child Behavior
Checklist (CBCL);
4. prior treatment with a social skills intervention or concurrent medicine
treatment.
Background summary
The core deficits of Autism Spectrum Disorder (ASD) are limited
social-communication capacities. Consequences of these social communication
deficits are a lack of social relationships, poor quality friendships and risk
of anxiety or depression. Subsequently, this may lead to poor functioning in
multiple domains/ contexts, such as a lack of independence, poor academic
performance and underemployment. Given this impact on societal functioning,
there is a strong need for treatments to improve social competence in this
highly vulnerable population. The UCLA PEERS Program, parent-assisted social
skills intervention, has been found to improve the parent-reported social
competence in adolescents with Autism Spectrum Disorders in the USA and Korea
relative to a waiting list comparison group. Although these results are
promising, these previous studies mostly used parent-reported outcome measures
and as parents were involved in the training, these may be biased. In addition,
little is known about whether the specific elements of the training are
effective in producing the effect of improved social competence or whether this
is the effect of general therapeutic factors, such as attention etc (i.e.,
doing something is better than doing nothing).
Study objective
We aim to evaluate the effectiveness of the Dutch translation and cultural
adaptation of PEERS program in a randomized controlled trial (RCT) using an
active treatment control group and a blinded observation of social competence
as outcome measure. In addition, we aim to extend our knowledge of the possible
mechanisms of effectiveness (mediators) of the PEERS program and participant
characteristics (moderators) that influence the effectiveness.
Study design
The current study is a randomized controlled trial (RCT) where each participant
is randomly assigned to either the PEERS social skills intervention (n = 75) or
an active treatment control condition (n = 75). Both interventions will have
similar duration and frequency (14 sessions held once a week). Assessments will
be conducted prior to the randomization (baseline: T1), halfway during the
intervention (week 7: T2), directly at the end of the 14-week intervention
(week 14: T3), and a 14-week follow-up after the intervention (week 28: T4).
Intervention
The Program for Education and Enrichment of Relational Skills (PEERS) is a
manualized social skills training program designed to learn cognitively able
adolescents with ASD social skills to help them make and keep friends and deal
with peer conflicts (Laugeson & Frankel, 2010; Laugeson et al., 2012; Laugeson
et al., 2009). It is parent-assisted training that addresses elements of social
functioning for adolescents such as two-way conversational skills, making
friends, choosing appropriate humour, handling rejection, bullying or rumours
(Laugeson & Frankel, 2010; see Table 3 for a detailed overview of topics that
are covered each session)). The social skills are taught using
psychoeducational and cognitive-behavioural treatment techniques (i.e. homework
review, role play demonstrations, rehearsal exercises, homework assignments).
The homework assignments require the adolescent to rehearse the newly learned
skills with peers to enhance the generalization of the skills to other
settings. The UCLA PEERS Program consists of 90-minutes sessions, delivered
once a week for 14 weeks with parents and adolescents attending separate
sessions.
The active treatment control condition (ATCC) is a manualized psycho-education
program related to general issues in adolescents such as school,
independence/responsibility, physical appearance and changes, dealing with
emotions and boundaries. The ATCC will be based on an existing treatment on
psychosexual development for cognitively able adolescents with ASD (Tackling
Teenage) and a program focused on frequent problems experienced by adolescents
with ADHD in the home or school setting (PowerCoaching). The ATCC will be
designed to have the same frequency and duration as the PEERS intervention. The
emphasis of the ATCC will be less on skills and behavioral rehearsal but more
on knowledge. The adolescents who will participate in ATCC will also undergo
the same assessments as the PEERS group.
Study burden and risks
Adolescents with ASD who will participate in this study will receive several
benefits. They will receive a training in a small group format that allow the
discussion of the personal experiences of the adolescents and parents on topics
that these families struggle with. Adolescents who will be randomized to the
PEERS intervention are hypothesized to show improvements in social knowledge,
social cognition and social competence. However, the adolescents who will
receive the active treatment control condition are also expected to show some
improvements (perhaps on other areas) due to some general therapeutic effects.
The risks associated with participation can be considered negligible. The
burden will consist of the time that adolescents and parents need to invest in
participating in the intervention and assessments. For adolescents this is
about 4 hours in total for the assessments (1 hour per time point) and the
parent and teacher about 2 hours (30 minutes per time point). The intervention
consists of 14 sessions of 90 minutes for the adolescent and parent.
Wytemaweg 8
Rotterdam 3015 CN
NL
Wytemaweg 8
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
(a) chronological age between 12 and 18 years old,
(b) in a secondary education,
(c) diagnosis of pervasive developmental disorder-not otherwise specific (PDD-NOS), Asperger's syndrome or autistic disorder by a reliable mental health professional established using the Autism Diagnostic Observation Schedule (ADOS-2) and 3Di;
(d) Dutch fluency for participants and parents and willing to participate in the treatment;
(e) IQ>70.
Exclusion criteria
(a) a history of major mental illness (e.g., schizophrenia, bipolar disorder, or other types of psychotic disorders, and
(b) any visual, hearing or physical impairments that prohibit participation in the intervention .
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 | NL57472.078.16 |