Skip to main content
Top
Gepubliceerd in: Journal of Autism and Developmental Disorders 5/2009

01-05-2009 | Original Paper

Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders

Auteurs: Lawrence Scahill, Michael G. Aman, Christopher J. McDougle, L. Eugene Arnold, James T. McCracken, Benjamin Handen, Cynthia Johnson, James Dziura, Eric Butter, Denis Sukhodolsky, Naomi Swiezy, James Mulick, Kimberly Stigler, Karen Bearss, Louise Ritz, Ann Wagner, Benedetto Vitiello

Gepubliceerd in: Journal of Autism and Developmental Disorders | Uitgave 5/2009

Log in om toegang te krijgen
share
DELEN

Deel dit onderdeel of sectie (kopieer de link)

  • Optie A:
    Klik op de rechtermuisknop op de link en selecteer de optie “linkadres kopiëren”
  • Optie B:
    Deel de link per e-mail

Abstract

This paper presents the rationale for a 24-week, randomized trial designed to test whether risperidone plus structured parent training would be superior to risperidone only on measures of noncompliance, irritability and adaptive functioning. In this model, medication reduces tantrums, aggression and self-injury; parent training promotes improvement in noncompliance and adaptive functioning. Thus, medication and parent training target related, but separate, outcomes. At week 24, the medication was gradually withdrawn to determine whether subjects in the combined treatment group could be managed on a lower dose or off medication without relapse. Both symptom reduction and functional improvement are important clinical treatment targets. Thus, experimental evidence on the beneficial effects of combining pharmacotherapy and exportable behavioral interventions is needed to guide clinical practice.
Literatuur
go back to reference Abikoff, H., Hechtman, L., Klein, R. G., Weiss, G., Fleiss, K., Etcovitch, J., et al. (2004). Symptomatic improvement in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 43, 802–811.PubMedCrossRef Abikoff, H., Hechtman, L., Klein, R. G., Weiss, G., Fleiss, K., Etcovitch, J., et al. (2004). Symptomatic improvement in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. Journal of the American Academy of Child and Adolescent Psychiatry, 43, 802–811.PubMedCrossRef
go back to reference Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J. (1985). The Aberrant Behavior Checklist: A behavior rating scale for the assessment of treatment effects. American Journal of Mental Deficiency, 89, 485–491.PubMed Aman, M. G., Singh, N. N., Stewart, A. W., & Field, C. J. (1985). The Aberrant Behavior Checklist: A behavior rating scale for the assessment of treatment effects. American Journal of Mental Deficiency, 89, 485–491.PubMed
go back to reference Aman, M. G., Singh, N. N., & Turbott, S. H. (1987). Reliability of the Aberrant Behavior Checklist and the effect of variations in instructions. American Journal of Mental Deficiency, 92, 237–240.PubMed Aman, M. G., Singh, N. N., & Turbott, S. H. (1987). Reliability of the Aberrant Behavior Checklist and the effect of variations in instructions. American Journal of Mental Deficiency, 92, 237–240.PubMed
go back to reference Barkley, R. A., & Murphy, K. R. (1998). Attention deficit hyperactivity disorder: A clinical workbook (2nd ed.). New York: Guilford. Barkley, R. A., & Murphy, K. R. (1998). Attention deficit hyperactivity disorder: A clinical workbook (2nd ed.). New York: Guilford.
go back to reference Borenstein, M., Rothman, H., & Cohen, J. (1997). Power and precision program. New Jersey: Erlbaum. Borenstein, M., Rothman, H., & Cohen, J. (1997). Power and precision program. New Jersey: Erlbaum.
go back to reference Brown, E. C., Aman, M. G., & Havercamp, S. M. (2002). Factor analysis and norms for parent ratings on the Aberrant Behavior Checklist-community for young people in special education. Research in Developmental Disabilities, 23, 45–60.PubMedCrossRef Brown, E. C., Aman, M. G., & Havercamp, S. M. (2002). Factor analysis and norms for parent ratings on the Aberrant Behavior Checklist-community for young people in special education. Research in Developmental Disabilities, 23, 45–60.PubMedCrossRef
go back to reference Campbell, M., Armenteros, J. L., Malone, R. P., Adams, P. B., Eisenberg, Z. W., & Overall, J. E. (1997). Neuroleptic-related dyskinesias in autistic children: a prospective, longitudinal study. Journal of the American Academy of Child and Adolescent Psychiatry, 36, 835–843.PubMedCrossRef Campbell, M., Armenteros, J. L., Malone, R. P., Adams, P. B., Eisenberg, Z. W., & Overall, J. E. (1997). Neuroleptic-related dyskinesias in autistic children: a prospective, longitudinal study. Journal of the American Academy of Child and Adolescent Psychiatry, 36, 835–843.PubMedCrossRef
go back to reference Carter, A. S., Volkmar, F. R., Sparrow, S. S., Wang, J. J., Lord, C., Dawson, G., et al. (1998). The Vineland Adaptive Behavior Scales: Supplementary norms for individuals with autism. Journal of Autism and Developmental Disorders, 28, 287–302.PubMedCrossRef Carter, A. S., Volkmar, F. R., Sparrow, S. S., Wang, J. J., Lord, C., Dawson, G., et al. (1998). The Vineland Adaptive Behavior Scales: Supplementary norms for individuals with autism. Journal of Autism and Developmental Disorders, 28, 287–302.PubMedCrossRef
go back to reference National Research Council. (2001). Educating children with autism. Washington, DC: National Academies Press. National Research Council. (2001). Educating children with autism. Washington, DC: National Academies Press.
go back to reference Fombonne, E. (2003). The prevalence of autism. Journal of the American Medical Association, 289, 87–89.PubMedCrossRef Fombonne, E. (2003). The prevalence of autism. Journal of the American Medical Association, 289, 87–89.PubMedCrossRef
go back to reference Gadow, K. D., Devincent, C. J., Pomeroy, J., & Azizian, A. (2005). Comparison of DSM-IV symptoms in elementary school-age children with PDD versus clinic and community samples. Autism, 9(4), 392–415.PubMedCrossRef Gadow, K. D., Devincent, C. J., Pomeroy, J., & Azizian, A. (2005). Comparison of DSM-IV symptoms in elementary school-age children with PDD versus clinic and community samples. Autism, 9(4), 392–415.PubMedCrossRef
go back to reference Gibbons, R. D., Hedeker, D., Elkin, I., Waternaux, C., Kraemer, H. C., Greenhouse, J. B., et al. (1993). Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of depression collaborative research program dataset. Archives of General Psychiatry, 50, 739–750.PubMed Gibbons, R. D., Hedeker, D., Elkin, I., Waternaux, C., Kraemer, H. C., Greenhouse, J. B., et al. (1993). Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Application to the NIMH treatment of depression collaborative research program dataset. Archives of General Psychiatry, 50, 739–750.PubMed
go back to reference Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington, DC: DHEW, NIMH. Guy, W. (1976). ECDEU assessment manual for psychopharmacology. Washington, DC: DHEW, NIMH.
go back to reference Hollander, E., Phillips, A., Chaplin, W., Zagursky, K., Novotny, S., Wasserman, S., et al. (2005). A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology, 30, 582–589.PubMedCrossRef Hollander, E., Phillips, A., Chaplin, W., Zagursky, K., Novotny, S., Wasserman, S., et al. (2005). A placebo controlled crossover trial of liquid fluoxetine on repetitive behaviors in childhood and adolescent autism. Neuropsychopharmacology, 30, 582–589.PubMedCrossRef
go back to reference Johnson, C. R., Handen, B. L., Butter, E., Wagner, A., Mulick, J., Sukhodolsky, D. G., et al. (2007). Development of a parent training program for children with pervasive developmental disorders. Behavioral Interventions, 22, 201–221.CrossRef Johnson, C. R., Handen, B. L., Butter, E., Wagner, A., Mulick, J., Sukhodolsky, D. G., et al. (2007). Development of a parent training program for children with pervasive developmental disorders. Behavioral Interventions, 22, 201–221.CrossRef
go back to reference Kane, J. M., Carson, W. H., Saha, A. R., McQuade, R. D., Ingenito, G. G., Zimbroff, D. L., et al. (2002). Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. Journal of Clinical Psychiatry, 63, 763–771.PubMed Kane, J. M., Carson, W. H., Saha, A. R., McQuade, R. D., Ingenito, G. G., Zimbroff, D. L., et al. (2002). Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. Journal of Clinical Psychiatry, 63, 763–771.PubMed
go back to reference Kazdin, A., & Weisz, J. R. (Eds.). (2003). Evidence-based psychotherapies for children and adolescents. New York: Guilford Press. Kazdin, A., & Weisz, J. R. (Eds.). (2003). Evidence-based psychotherapies for children and adolescents. New York: Guilford Press.
go back to reference Kraijer, D. (2000). Review of adaptive behavior studies in mentally retarded persons with autism/pervasive developmental disorder. Journal of Autism and Developmental Disorders, 30, 39–47.PubMedCrossRef Kraijer, D. (2000). Review of adaptive behavior studies in mentally retarded persons with autism/pervasive developmental disorder. Journal of Autism and Developmental Disorders, 30, 39–47.PubMedCrossRef
go back to reference Lord, C., Wagner, A., Rogers, S., Szatmari, P., Aman, M., Charman, T., et al. (2005). Challenges in evaluating psychosocial interventions for autistic spectrum disorders. Journal of Autism and Developmental Disorders, 35, 695–708. (discussion 709–711).PubMedCrossRef Lord, C., Wagner, A., Rogers, S., Szatmari, P., Aman, M., Charman, T., et al. (2005). Challenges in evaluating psychosocial interventions for autistic spectrum disorders. Journal of Autism and Developmental Disorders, 35, 695–708. (discussion 709–711).PubMedCrossRef
go back to reference Lovaas, O. I. (1987). Behavioral treatment and normal educational and intellectual functioning in young autistic children. Journal of Consulting and Clinical Psychology, 55, 3–9.PubMedCrossRef Lovaas, O. I. (1987). Behavioral treatment and normal educational and intellectual functioning in young autistic children. Journal of Consulting and Clinical Psychology, 55, 3–9.PubMedCrossRef
go back to reference McDougle, C. J., Scahill, L., Aman, M. G., McCracken, J. T., Tierney, E., Davies, M., et al. (2005). Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology. American Journal of Psychiatry, 162, 1142–1148.PubMedCrossRef McDougle, C. J., Scahill, L., Aman, M. G., McCracken, J. T., Tierney, E., Davies, M., et al. (2005). Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology. American Journal of Psychiatry, 162, 1142–1148.PubMedCrossRef
go back to reference McDougle, C. J., Stigler, K. A., Erickson, C. A., & Posey, D. J. (2008). Atypical antipsychotics in children and adolescents with autistic and other pervasive developmental disorders. Journal of Clinical Psychiatry, 69(Suppl 4), 15–20.PubMed McDougle, C. J., Stigler, K. A., Erickson, C. A., & Posey, D. J. (2008). Atypical antipsychotics in children and adolescents with autistic and other pervasive developmental disorders. Journal of Clinical Psychiatry, 69(Suppl 4), 15–20.PubMed
go back to reference MTA Cooperative Group. (1999). Multimodal treatment study of children with ADHD: A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1073–1086.CrossRef MTA Cooperative Group. (1999). Multimodal treatment study of children with ADHD: A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Archives of General Psychiatry, 56, 1073–1086.CrossRef
go back to reference Pediatric OCD Treatment Study (POTS) Team. (2004). Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: The Pediatric OCD Treatment Study (POTS) randomized controlled trial. Journal of the American Medical Association, 292, 1969–1976.CrossRef Pediatric OCD Treatment Study (POTS) Team. (2004). Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: The Pediatric OCD Treatment Study (POTS) randomized controlled trial. Journal of the American Medical Association, 292, 1969–1976.CrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2002). Risperidone in children with autism for serious behavioral problems. New England Journal of Medicine, 347, 314–321.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2002). Risperidone in children with autism for serious behavioral problems. New England Journal of Medicine, 347, 314–321.CrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2005a). Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry, 62, 1266–1274.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2005a). Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Archives of General Psychiatry, 62, 1266–1274.CrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2005b). Risperidone treatment of autistic disorder: Longer term benefits and blinded discontinuation after six months. American Journal of Psychiatry, 162, 1361–1369.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2005b). Risperidone treatment of autistic disorder: Longer term benefits and blinded discontinuation after six months. American Journal of Psychiatry, 162, 1361–1369.CrossRef
go back to reference Research Units on Pediatric Psychopharmacology Autism Network. (2007). Parent training for children with pervasive developmental disorders: A multi-site feasibility trial. Behavioral Interventions, 22, 179–199.CrossRef Research Units on Pediatric Psychopharmacology Autism Network. (2007). Parent training for children with pervasive developmental disorders: A multi-site feasibility trial. Behavioral Interventions, 22, 179–199.CrossRef
go back to reference Scahill, L., & Martin, A. (2005). Psychopharmacology. In F. Volkmar, A. Klin, & R. Paul (Eds.), Handbook of autism and pervasive developmental disorders (3rd ed., pp. 1102–1117). New York: Wiley. Scahill, L., & Martin, A. (2005). Psychopharmacology. In F. Volkmar, A. Klin, & R. Paul (Eds.), Handbook of autism and pervasive developmental disorders (3rd ed., pp. 1102–1117). New York: Wiley.
go back to reference Scahill, L., Solanto, M., & McGuire, J. (2008). The science and ethics of placebo in pediatric psychopharmacology. Ethics and Behavior, 18, 266–285.CrossRef Scahill, L., Solanto, M., & McGuire, J. (2008). The science and ethics of placebo in pediatric psychopharmacology. Ethics and Behavior, 18, 266–285.CrossRef
go back to reference Schreibman, L. (2000). Intensive behavioral/psychoeducational treatments for autism: Research needs and future directions. Journal of Autism and Developmental Disorders, 30, 373–378.PubMedCrossRef Schreibman, L. (2000). Intensive behavioral/psychoeducational treatments for autism: Research needs and future directions. Journal of Autism and Developmental Disorders, 30, 373–378.PubMedCrossRef
go back to reference Shea, S., Turgay, A., Carroll, A., Schulz, M., Orlik, H., Smith, I., et al. (2004). Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics, 114(5), 634–641.CrossRef Shea, S., Turgay, A., Carroll, A., Schulz, M., Orlik, H., Smith, I., et al. (2004). Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders. Pediatrics, 114(5), 634–641.CrossRef
go back to reference Shrout, P. E., & Bolger, N. (2002). Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychological Methods, 7, 422–445.PubMedCrossRef Shrout, P. E., & Bolger, N. (2002). Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychological Methods, 7, 422–445.PubMedCrossRef
go back to reference Smith, T., Buch, G. A., & Gamby, T. E. (2000). Parent-directed, intensive early intervention for children with pervasive developmental disorder. Research in Developmental Disabilities, 21, 297–309.PubMedCrossRef Smith, T., Buch, G. A., & Gamby, T. E. (2000). Parent-directed, intensive early intervention for children with pervasive developmental disorder. Research in Developmental Disabilities, 21, 297–309.PubMedCrossRef
go back to reference Smith, T., Scahill, L., Dawson, G., Guthrie, D., Lord, C., Odom, S., et al. (2007). Designing research studies on psychosocial interventions in autism. Journal of Autism and Developmental Disorders, 37, 354–366.PubMedCrossRef Smith, T., Scahill, L., Dawson, G., Guthrie, D., Lord, C., Odom, S., et al. (2007). Designing research studies on psychosocial interventions in autism. Journal of Autism and Developmental Disorders, 37, 354–366.PubMedCrossRef
go back to reference Sparrow, S. S., Balla, D. A., & Cicchetti, D. V. (1984). Vineland Adaptive Behavior scales: Survey form manual. Circle Pines: American Guidance Service. Sparrow, S. S., Balla, D. A., & Cicchetti, D. V. (1984). Vineland Adaptive Behavior scales: Survey form manual. Circle Pines: American Guidance Service.
go back to reference Treatment for Adolescents with Depression Study (TADS) Team. (2004). Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. Journal of the American Medical Association, 292, 807–820.CrossRef Treatment for Adolescents with Depression Study (TADS) Team. (2004). Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents with Depression Study (TADS) randomized controlled trial. Journal of the American Medical Association, 292, 807–820.CrossRef
go back to reference Williams, S. K., Scahill, L., Vitiello, B., Aman, M. G., Arnold, L. E., McDougle, C. J., et al. (2006). Risperidone and adaptive behavior in children with autism. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 431–439.PubMedCrossRef Williams, S. K., Scahill, L., Vitiello, B., Aman, M. G., Arnold, L. E., McDougle, C. J., et al. (2006). Risperidone and adaptive behavior in children with autism. Journal of the American Academy of Child and Adolescent Psychiatry, 45, 431–439.PubMedCrossRef
Metagegevens
Titel
Trial Design Challenges When Combining Medication and Parent Training in Children with Pervasive Developmental Disorders
Auteurs
Lawrence Scahill
Michael G. Aman
Christopher J. McDougle
L. Eugene Arnold
James T. McCracken
Benjamin Handen
Cynthia Johnson
James Dziura
Eric Butter
Denis Sukhodolsky
Naomi Swiezy
James Mulick
Kimberly Stigler
Karen Bearss
Louise Ritz
Ann Wagner
Benedetto Vitiello
Publicatiedatum
01-05-2009
Uitgeverij
Springer US
Gepubliceerd in
Journal of Autism and Developmental Disorders / Uitgave 5/2009
Print ISSN: 0162-3257
Elektronisch ISSN: 1573-3432
DOI
https://doi.org/10.1007/s10803-008-0675-2

Andere artikelen Uitgave 5/2009

Journal of Autism and Developmental Disorders 5/2009 Naar de uitgave