Primary Objective: The main objective is to investigate the effectiveness of PRT compared to CAU in school-aged children and adolescents with ASD.The primary research question is:1) Directly after treatment and at follow-up, what is the…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Significant response on the SRS (continuous measure): generalized
improvement in child's social and communicative skills
Secondary outcome
-Clinically significant increase at the CGI-I
-Generalized social and communicative skills (SRS), percentage of clinical
response
-Child rearing pressur of parents (OBVL)
-Parent-child interaction (PCI)
-Change in ASD symptoms (ADOS-2)
-Child adaptive behaviour (VABS)
-Child internalizing and externalizing symptoms (CBCL)
Background summary
Autism spectrum disorder (ASD) is characterized by persistent deficits in
social communication and social interaction and restricted, repetitive patterns
of behaviour, interests, or activities (APA, 2013). Despite the large variety
of treatment methods for ASD (Seida et al., 2009), sufficient scientific
evidence for the effectiveness of the interventions in targeting the core
symptoms of ASD (i.e. social communication and social interaction) is lacking.
A promising intervention that targets the core symptoms of ASD is Pivotal
Response Treatment (PRT) (Koegel & Koegel, 2006). Earlier studies have shown
that PRT, by targeting those pivotal areas, is effective in improving a variety
of social and communicative skills in children with ASD, including joint
attention (Vismara & Lyons, 2007), turn taking (Harper, Symon, & Frea, 2008),
question asking (Koegel, Camarata, Valdez-Menchaca, & Koegel, 1998; Koegel,
Koegel, Green-Hopkins, & Barnes, 2010) and spontaneous initiations (Kuhn,
Bodkin, Devlin, & Doggett, 2008; Pierce & Schreibman, 1995). However, the
majority of studies is conducted in children under the age of 6 (Verschuur,
Didden, Lang, Sigafoos, & Huskens, 2014) and consequently, sufficient
scientific evidence that supports the use of PRT in older children and
adolescents is lacking.The current study aims to investigate the promising
treatment option, PRT in a highly needed target population (i.e. school-aged
children and adolescents with ASD). If PRT is effective in significantly
reducing the core symptoms of ASD in this age group, PRT will be further
implemented within Karakter and The Netherlands.
Study objective
Primary Objective:
The main objective is to investigate the effectiveness of PRT compared to CAU
in school-aged children and adolescents with ASD.
The primary research question is:
1) Directly after treatment and at follow-up, what is the effectiveness of PRT
compared to care-as-usual in improving:
-child social and communicative skills?
Secondary Objectives:
2) Which child, parent and structural intervention factors
(predictors/moderators) have influence on effectiveness of treatment?
3) Compared to care-as-usual, what is the effectiveness of PRT in improving
child clinical global functioning?
4) Compared to care-as-usual, what is the effectiveness of PRT in improving
feelings of competence in parents?
5) Compared to care-as-usual, what is the effectiveness of PRT in improving
parent-child interaction?
Study design
A randomized controlled trail with partly blinded measures at end-point and
follow-up.
Intervention
Participants are randomized to one of the following conditions:
1) PRT condition: PRT on top of psycho-education
2) CAU condition: regular treatment of ASD (e.g. guidance of parents) on top of
psycho-education
Study burden and risks
Patients and their parents/caregivers in both treatment groups (PRT and CAU)
are expected to highly benefit from their treatment. Both groups receive
psycho-education on ASD prior to treatment and medical management is continued,
when necessary. In both groups, trained clinicians focused on ASD provide
high-quality care. Within both groups, gains are expected in both child-related
factors (e.g. lower severity of symptoms) and parent-related factors (e.g.
lower parenting stress).
The study is highly therapeutic and is expected to be highly beneficial for
both subjects and their parents/caregivers. The risk of participating in the
study are considered negligible and the burden associated with participation is
estimated to be very low.
Reinier Postlaan 12
Nijmegen 6525CG
NL
Reinier Postlaan 12
Nijmegen 6525CG
NL
Listed location countries
Age
Inclusion criteria
• aged 9 - 15 years at inclusion in the study
• Total Intelligence Quotient (TIQ) of >= 80
• clinically diagnosed with autism spectrum disorder (DSM-IV-TR and DSM-5) or social communication disorder (DSM-5)
• at least one of the parents is able to understand and speak the Dutch language
Exclusion criteria
-Systemic problems that limit the possibility to engage in an intensive treatment, focused on training both the child/adolescent and parents.
-Presence of comorbid problems that require treatment first.
-Problems with accepting child's diagnosis of ASD by child and/or parent
-Severe parental psychopathology
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL54706.091.15 |
OMON | NL-OMON23411 |