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
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03222375 -
SQUED™ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism
|
N/A | |
Completed |
NCT02568631 -
Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls
|
N/A | |
Completed |
NCT02708290 -
Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
|
||
Completed |
NCT02369445 -
Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
|
N/A | |
Completed |
NCT01592747 -
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
|
Phase 2 | |
Completed |
NCT01617460 -
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
|
Phase 3 | |
Completed |
NCT01400269 -
An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism
|
N/A | |
Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
Completed |
NCT00692315 -
Treating Oxidative Stress in Children With Autism
|
N/A | |
Completed |
NCT00365859 -
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
|
Phase 3 | |
Completed |
NCT00198107 -
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
|
Phase 3 | |
Completed |
NCT00095420 -
Relationship Training for Children With Autism and Their Peers
|
N/A | |
Completed |
NCT00027404 -
Study of Fluoxetine in Adults With Autistic Disorder
|
N/A | |
Recruiting |
NCT05910502 -
Project AFECT (Autism Family Empowerment Coaching and Training Program)
|
N/A | |
Completed |
NCT04820998 -
Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care
|
||
Withdrawn |
NCT05413187 -
A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder
|
Phase 2 | |
Recruiting |
NCT02275455 -
Design Of WELL Being Monitoring Systems, Application in Autism
|
N/A | |
Completed |
NCT02766101 -
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges
|
N/A | |
Completed |
NCT01977248 -
Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12
|
N/A | |
Terminated |
NCT01592773 -
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
|
Phase 2 |