Autistic Disorder Clinical Trial
Official title:
A Cognitive-Behavioral Intervention for Children With Autism Spectrum Disorders
This study will develop and test a treatment aimed at reducing anxiety in social situations for children and adolescents with autism spectrum disorders.
Autism spectrum disorders (ASDs) are developmental disorders with similar features,
including problems communicating, problems interacting socially, and the presence of
routines or repetitive behaviors. These disorders can have a range of severities. They
include autistic disorder, Asperger's syndrome, and pervasive developmental disorder not
otherwise specified (PDD-NOS). In addition to their core impairment in social functioning,
children and adolescents with ASDs often have anxiety about social interactions, which
compounds their difficulties and can limit the benefits of treatment. This study will
develop and test a treatment program for developing social skills and reducing anxiety in
children and adolescents with ASDs.
Participation in this study will last 12 to 14 weeks, with follow-up visits occurring 3 and
12 months after that. Participants will be randomly assigned to receive the treatment
program either immediately or after being on a wait list. The treatment program will consist
of 12 to 14 weekly individual therapy sessions that teach children and adolescents about
ASDs, use cognitive-behavioral interventions to address problematic thinking and acting,
deliver social skills instruction, and give opportunities to practice skills—including some
practice outside the clinic in naturalistic settings. Every 2 weeks, starting at Week 4,
children and adolescents will also attend group sessions to discuss strategies and practice
social skills. Parents of the participants will be included at the end of each individual
session for several minutes. After the participants assigned to immediate treatment complete
the program, participants from the wait list will be offered the treatment.
Child and adolescent participants and their parents will complete assessments at baseline,
midpoint in treatment, post-treatment (Week 12 or 14), and 3- and 12-month follow-ups.
Participants assigned to the wait list condition will complete assessments only at baseline,
before entering treatment (Week 12 or 14), and after completing treatment. Assessments will
involve questionnaires about social and emotional functioning, interviews with study
researchers, and surveys on satisfaction with the study. The child or adolescent's primary
teacher will also complete questionnaires about the child.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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