Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - the SOSTRA trial protocol

Ole Jakob Storebø, Jesper Pedersen, Maria Skoog, Per Hove Thomsen, Per Winkel, Christian Gluud, Erik Simonsen, Ole Jakob Storebø, Jesper Pedersen, Maria Skoog, Per Hove Thomsen, Per Winkel, Christian Gluud, Erik Simonsen

Abstract

Background: Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions.

Methods/design: The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms.

Discussion: We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone.

Trial registration: ClinicalTrials (NCT): NCT00937469.

Figures

Figure 1
Figure 1
A flow chart of the SOSTRA design.
Figure 2
Figure 2
Medical protocol.

References

    1. Polanczyk G, Rohde LA. Epidemiology of attention-deficit/hyperactivity disorder across lifespan. Curr Opin Psychiatry. 2007;20:386–92. doi: 10.1097/YCO.0b013e3281568d7a.
    1. Goldman LS, Genel M, Bezman RJ, Slanetz PJ. Diagnosis and treatment of attention-deficit disorder in children and adolescents. J Am Med Assoc. 1998;279:1100–07. doi: 10.1001/jama.279.14.1100.
    1. Barkley RA. Attention Deficit Hyperactivity Disorder: A Handbook for Diagnoses and Treatment. New York: Guildford; 1998.
    1. Gadow KD, Nolan EE, Sverd J, Sprafkin J, Paolicelli LL. Methylphenidate in aggressive-hyperactive boys: I. Effects on peer aggression in public school settings. J Am Acad Child Adolesc Psychiatry. 1990;29:710–8. doi: 10.1097/00004583-199009000-00006.
    1. Malone MA, Swanson JM. Effects of methylphenidate on impulsive responding in children with attention deficit hyperactivity disorder. J Child Neurol. 1993;8:157–63. doi: 10.1177/088307389300800209.
    1. Spencer T, Biederman J, Wilens T, Harding M, O'Donnell D, Griffin S. Pharmacotherapy of attention-deficit hyperactivity disorder across the life cycle. J Am Acad Child Adolesc Psychiatry. 1996;35:409–32. doi: 10.1097/00004583-199604000-00008.
    1. Barkley RA. A review of stimulant drug research with hyperactive children. J Child Psychol Psychiatry. 1997;18:137–65. doi: 10.1111/j.1469-7610.1977.tb00425.x.
    1. Gilberg C, Melander H, von Knorring A, Janols L, Thernlund G, Hagglof B, Eidevall-Walin L, Gustafsson P, Kopp S. Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms. A randomized, double blind, placebo-controlled trial. Arch Gen Psychiatry. 1997;54:857–864.
    1. Cyr M, Brown C. Current drug therapy recommendations for the treatment of attention deficit hyperactivity disorder. Drug. 1998;56:215–223. doi: 10.2165/00003495-199856020-00005.
    1. Klassen A, Miller A, Raina P, Lee SK, Olsen L. Attention-deficit hyperactivity disorder on children and youth: a quantitative systematic review of the efficacy of different management strategies. Can J Psychiatry. 1999;44:1007–1016.
    1. MTA Cooperation Group. A 14-month randomized clinical trial of treatment strategies for attention deficit hyperactivity disorder. Arch Gen Psychiatry. 1999;56:1073–1086. doi: 10.1001/archpsyc.56.12.1073.
    1. Gilmore A, Milne R. Methylphenidate in children with hyperactivity: review and cost-utility analysis. Pharmacoepidemiol Drug Safety. 2001;10:85–94. doi: 10.1002/pds.564.
    1. Hinshaw S, Henker B, Whalen C. Cognitive-behavioural interventions for hyperactive boys: comparative and combined effects. J Clin Psychol. 1984;52:739–749.
    1. Hinshaw S, Henker B, Whalen C. Self-control in hyperactive boys in anger inducing situations: effects on cognitive behavioral training and of methylphenidate. J Abnormal Child Psychol. 1984;12:55–77. doi: 10.1007/BF00913461.
    1. Tannock R, Martinussen R. Reconceptualizing ADHD. Educational Leadership. 2001;59:20–25.
    1. Whalen CK, Henker B. The social worlds of hyperactive (ADHD) children. Clin Psychol Rev. 1985;5:447–478. doi: 10.1016/0272-7358(85)90004-2.
    1. Landau S, Moore LA. Social skill deficit in children with attention-deficit hyperactivity disorder. School Psychol Rev. 1991;20:235–251.
    1. Hectman L, Weiss G. Long-term outcome of hyperactive children. Am J Orthopsychiatry. 1983;53:532–41. doi: 10.1111/j.1939-0025.1983.tb03397.x.
    1. Manuzza S, Klein RG, Konig PH, Giampino TL. In: Straight and Devious Pathways from Childhood to Adulthood. Robins LN, Rutter M, editor. New York: Cambridge University Press; 1990. Childhood predicators of psychiatric status in the young adulthood of hyperactive boys: a study controlling for chance associations; pp. 279–299.
    1. Manuzza S, Klein RG, Bessler A, Malloy P, LaPadula M. Adult psychiatric status of hyperactive boys grown up. A J Psychiatry. 1998;155:493–8.
    1. Biederman J, Faraone SV, Taylor A, Sienna M, Williamson S, Fine C. Diagnostic continuity between child and adolescent ADHD: findings from a longitudinal clinical sample. J Am Acad Child Adolesc Psychiatry. 1998;37:305–13. doi: 10.1097/00004583-199803000-00016.
    1. Biederman J, Mick E, Faraone SV. Age-dependent decline of symptoms of attention deficit hyperactivity disorder: impact of remission definition and symptom type. Am J Psychiatry. 2000;157:816–8. doi: 10.1176/appi.ajp.157.5.816.
    1. Barkley RA, Fischer M, Smallish L, Fletcher K. The persistence of attention-deficit/hyperactivity disorder into young adulthood as a function of reporting source and definition of disorder. J Abnormal Psychol. 2002;111:279–89. doi: 10.1037/0021-843X.111.2.279.
    1. Dalsgaard S, Mortensen PB, Frydenberg M, Thomsen PH. Conduct problems, gender and adult psychiatric outcome of children with attention-deficit hyperactivity disorder. Br J Psychiatry. 2002;181:416–21. doi: 10.1192/bjp.181.5.416.
    1. Jensen PS, Hinshaw SP, Kraemer HC, Lenora N, Newcorn JH, Abikoff HB, March JS, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Pelham WE, Severe JB, Swanson JM, Wells KC, Wigal T, Vitiello B. ADHD comorbidity findings from the MTA study: comparing comorbid subgroups. J Am Acad Child Adolesc Psychiatry. 2001;40:147–58. doi: 10.1097/00004583-200102000-00009.
    1. Kadesjö B, Gillberg C. The comorbidity of ADHD in the general population of Swedish school-age children. J Child Psychol Psychiatry. 2001;42:487–92.
    1. Fohlmann AH. In: Psykose hos unge. Symptomer, behandling og fremtid. Nordentoft M, Melau M, Iversen T, Kjær S, editor. København: Psykiatrifondens Forlag; 2009. Social færdighedstræning; pp. 161–189.
    1. Liberman RP. In: Psychiatric Rehabilitation of Chronic Mental Patients. Liberman RP, editor. Washington, D.C: American Psychiatric Press; 1998. Social skills training.
    1. Pfiffner LJ, McBurnet K. Social skills training with parent generalization: treatment effects for children with attention deficit disorder. J Consulting Clin Psychol. 1997;65:749–757. doi: 10.1037/0022-006X.65.5.749.
    1. Antshel KM, Remer R. Social skills training in children with attention deficit hyperactivity disorder: a randomized-controlled clinical trial. J Clin Child Adolescent Psychol. 2003;32:153–165.
    1. Tutty S, Gephart H, Wurzbacher K. Enhancing behavioural and social skill functioning in children newly diagnosed with hyperactivity disorder in a pediatric setting. Develop Behav Pediatr. 2003;24:1.
    1. Socialstyrelsen, Sverige. ADHD hos barn och vuxna. Stockholm, maj; 2002.
    1. Mager W, Millich R, Harris MJ, Howard A. Interventions group for adolescents with conduct problems: is aggression harmful or helpful? J Abnormal Child Psychol. 2005;33:349–62. doi: 10.1007/s10802-005-3572-6.
    1. Punto C, Turton P, Hughes P, White S, Gillberg C. ADHD and infant disorganized attachment: a prospective study of children next-born after stillbirth. J Atten Disord. 2006;10:83–91. doi: 10.1177/1087054705286058.
    1. Langager skole intra.
    1. Elliot SN, Gresham FM. Social Skills interventions for children. Behav Modif. 1993;17:287–313. doi: 10.1177/01454455930173004.
    1. Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia from School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997;36:980–8. doi: 10.1097/00004583-199707000-00021.
    1. Rutter M, Bailey A, Lord C. Social Communication Questionnaire (SCQ) Los Angeles: Western Psychological Services; 2003.
    1. Adler LA, Spencer T, Faraone SV, Kessler RC, Howens MJ, Biedermann J, Secnik K. Validity of pilot Adult ADHD Self-Report Scale (ASRS) to rate adult ADHD symptoms. Ann Clin Psychiatry. 2006;18:145–8. doi: 10.1080/10401230600801077.
    1. Fletcher J, Tannock R, Bishop DVM. Utility of brief teacher rating scales to identify children with educational problems. Aust J Psychol. 2001;53:63–71. doi: 10.1080/00049530108255125.
    1. Target M, Fonagy P, Shmueli-Goetz Y. Attachment representations in school-age children: the development of the child attachment interview (CAI) J Child Psychother. 2003;29:171–186. doi: 10.1080/0075417031000138433.
    1. Wechsler D. Wechsler Intelligence Scale for Children--3rd Edition (WISC-III®). Swedish edition. Stockholm: Psykologiförlaget AB; 1998.
    1. Conners KC. Conners Comprehensive Behavior Rating Scales (Conner's CBRS) Toronto, Canada: Multi-Health Systems Inc; 2008.
    1. Conners KC. Conners 3. Toronto, Canada: Multi-Health Systems Inc; 2008.
    1. Horns WF, Ialongo NS, Pascoe JM, Greenberg G, Packard T, Lopez M, Wagner A, Puttler L. Additive effects of psychostimulants, parent training, and self-control therapy with ADHD children. J Am Acad Child and Adolesc Psychiatry. 1991;30:233–240. doi: 10.1097/00004583-199103000-00011.
    1. Corkum PV, McKinnon MM, Mullane JC. The effect of involving classroom teachers in a parent training program for families of children with ADHD. Child Fam Behav Ther. 2005;27(4):29–49. doi: 10.1300/J019v27n04_02.
    1. International Conference on Harmonisation Guideline for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6 (R1). ICH Harmonised Tripartite Guideline; 1996.
    1. Guideline on missing data in confirmatory clinical trials. Committee for medicinal products for human use. European Medicines Agency, London; 2009. Draft. Doc. Ref. CPMP/EWP/1776/99 Rev. 1 Coor.
    1. Dmitrienko A, Tamhane AC, Wiens BL. General multistage gatekeeping procedures. Biometric J. 2008;50(5):667–677. doi: 10.1002/bimj.200710464.

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