Randomized Trial of Parent Training for Young Children With Autism (RUBI)
Primary Purpose
Child Development Disorders, Pervasive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Training
Psychoeducational Program
Sponsored by
About this trial
This is an interventional treatment trial for Child Development Disorders, Pervasive focused on measuring Pervasive Developmental Disorder, Autism, Children, Behavior Therapy, Aggression, Tantrums, Noncompliance
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
- Between ages 3 yrs 0 months and 6 yrs 11 months.
- No planned changes in the intensity of current treatment(s)
- Medication free or on stable medication
Exclusion Criteria:
- Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
- Participation in a structured parent training program in the past 2 years
- Developmental age < 18 months (IQ < 35)
Sites / Locations
- Yale University
- Emory University
- Indiana University
- University of Rochester
- Ohio State University
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parent Training
Psychoeducation
Arm Description
Outcomes
Primary Outcome Measures
Aberrant Behavior Checklist Irritability Subscale
Home Situations Questionnaire
Secondary Outcome Measures
Vineland Adaptive Behavior Scales
Clinical Global Impressions Improvement Scale
Full Information
NCT ID
NCT01233414
First Posted
October 29, 2010
Last Updated
April 7, 2016
Sponsor
Yale University
Collaborators
Emory University, Indiana University, Ohio State University, University of Pittsburgh, University of Rochester, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01233414
Brief Title
Randomized Trial of Parent Training for Young Children With Autism
Acronym
RUBI
Official Title
Randomized Trial of Parent Training for Young Children With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Emory University, Indiana University, Ohio State University, University of Pittsburgh, University of Rochester, National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this 24 week study is to determine whether a new Parent Training program is effective in reducing disruptive behaviors in young children with pervasive developmental disorders.
Detailed Description
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD also have behavior problems, including defiance of rules, aggression, and tantrums. The purpose of this study is to evaluate a new Parent Training program designed to decrease these behavior problems and improve daily living skills.
Following confirmation of eligibility, participants will be randomly assigned to receive either Parent Training or a Psychoeducational Program. The Parent Training program involves specific suggestions about how to deal with behavior problems. The Psychoeducational program covers specific issues related to autism and parenting, including an co-occurring medical conditions and treatment options.
Parents will attend up to 13 one-on-one sessions with a trained therapist over a 24-week period. Participation in the study also involves 2 home visits and 6 monthly assessment visits. The purpose of the assessment visits is to evaluate the child's response to treatment. Evaluations will also be conducted at 3 and 6 months after completion of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Development Disorders, Pervasive
Keywords
Pervasive Developmental Disorder, Autism, Children, Behavior Therapy, Aggression, Tantrums, Noncompliance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parent Training
Arm Type
Experimental
Arm Title
Psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Intervention Description
The Parent Training program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute treatment sessions over a 24-week period. Topics covered in the program include reinforcement, teaching compliance, and functional communication. The treatment sessions employ direct instruction, review of video-taped examples, practice activities, behavior rehearsal with feedback, and role-playing to accomplish specific skill acquisition. Parents will be given specific homework assignments between sessions.
Intervention Type
Other
Intervention Name(s)
Psychoeducational Program
Intervention Description
The Psychoeducational program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute informational sessions over a 24-week period. The program provides an overview on a variety of topics including the complexities of a PDD diagnosis, co-occurring medical conditions, relevant aspects of child development, use of medications, treatment options for challenging behavior, nutritional issues, and complementary and alternative treatments.
Primary Outcome Measure Information:
Title
Aberrant Behavior Checklist Irritability Subscale
Time Frame
Week 24
Title
Home Situations Questionnaire
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Vineland Adaptive Behavior Scales
Time Frame
Week 24
Title
Clinical Global Impressions Improvement Scale
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
Between ages 3 yrs 0 months and 6 yrs 11 months.
No planned changes in the intensity of current treatment(s)
Medication free or on stable medication
Exclusion Criteria:
Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
Participation in a structured parent training program in the past 2 years
Developmental age < 18 months (IQ < 35)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Scahill, MSN, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cynthia Johnson, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tristram Smith, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luc Lecavalier, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naomi Swiezy, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Denis Sukhodolsky, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19858761
Citation
Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; Research Units on Pediatric Psychopharmacology Autism Network. Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1143-54. doi: 10.1097/CHI.0b013e3181bfd669. Erratum In: J Am Acad Child Adolesc Psychiatry. 2010 Jul;49(7):727.
Results Reference
background
Citation
Johnson CR, Handen BL, Butter E, Wagner A, Mulick J, Sukhodolsky DG, Williams, S, Swiezy, NA, Arnold LE, Aman MG, Scahill L, Stigler KA, McDougle CJ, Vitiello B, Smith T (2007). Development of a Parent Management Training Program for Children with Pervasive Developmental Disorders. Behav Intervent, 22:1-21.
Results Reference
background
PubMed Identifier
25898050
Citation
Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150. Erratum In: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.
Results Reference
background
PubMed Identifier
27343887
Citation
Scahill L, Bearss K, Lecavalier L, Smith T, Swiezy N, Aman MG, Sukhodolsky DG, McCracken C, Minshawi N, Turner K, Levato L, Saulnier C, Dziura J, Johnson C. Effect of Parent Training on Adaptive Behavior in Children With Autism Spectrum Disorder and Disruptive Behavior: Results of a Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2016 Jul;55(7):602-609.e3. doi: 10.1016/j.jaac.2016.05.001. Epub 2016 May 7.
Results Reference
derived
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Randomized Trial of Parent Training for Young Children With Autism
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