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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH081148 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Indiana University | OTHER |
| Ohio State University | OTHER |
| University of Pittsburgh |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent Training | Experimental |
| |
| Psychoeducation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist Irritability Subscale | Week 24 | |
| Home Situations Questionnaire | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Vineland Adaptive Behavior Scales | Week 24 | |
| Clinical Global Impressions Improvement Scale | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Scahill, MSN, PhD | Emory University | Principal Investigator |
| Cynthia Johnson, PhD | University of Pittsburgh | Principal Investigator |
| Tristram Smith, PhD | University of Rochester | Principal Investigator |
| Luc Lecavalier, PhD | Ohio State University | Principal Investigator |
| Naomi Swiezy, PhD | Indiana University | Principal Investigator |
| Denis Sukhodolsky, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19858761 | Background | 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. | |
| Background | 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. | ||
| 25898050 |
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| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D001321 | Autistic Disorder |
| D000374 | Aggression |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000067877 | Autism Spectrum Disorder |
| D000096762 | Aberrant Motor Behavior in Dementia |
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| OTHER |
| University of Rochester | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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| Psychoeducational Program | Other | 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. |
|
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| Background |
| 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. |
| 27343887 | Derived | 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. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |