The Effectiveness of Parent Training as a Treatment for Preschool Attention-Deficit/Hyperactivity Disorder: Study Protocol for a Randomized Controlled, Multicenter Trial of the New Forest Parenting Program in Everyday Clinical Practice

Anne-Mette Lange, David Daley, Morten Frydenberg, Charlotte U Rask, Edmund Sonuga-Barke, Per H Thomsen, Anne-Mette Lange, David Daley, Morten Frydenberg, Charlotte U Rask, Edmund Sonuga-Barke, Per H Thomsen

Abstract

Background: Parent training is recommended as the first-line treatment for attention-deficit/hyperactivity disorder (ADHD) in preschool children. The New Forest Parenting Programme (NFPP) is an evidence-based parenting program developed specifically to target preschool ADHD.

Objective: The objective of this trial is to investigate whether the NFPP can be effectively delivered for children referred through official community pathways in everyday clinical practice.

Methods: A multicenter randomized controlled parallel arm trial design is employed. There are two treatment arms, NFPP and treatment as usual. NFPP consists of eight individually delivered parenting sessions, where the child attends during three of the sessions. Outcomes are examined at three time points (T1, T2, T3): T1 (baseline), T2 (week 12, post intervention), and T3 (6 month follow/up). 140 children between the ages of 3-7, with a clinical diagnosis of ADHD, informed by the Development and Well Being Assessment, and recruited from three child and adolescent psychiatry departments in Denmark will take part. Randomization is on a 1:1 basis, stratified for age and gender.

Results: The primary endpoint is change in ADHD symptoms as measured by the Preschool ADHD-Rating Scale (ADHD-RS) by T2. Secondary outcome measures include: effects on this measure at T3 and T2 and T3 measures of teacher reported Preschool ADHD-RS scores, parent and teacher rated scores on the Strength & Difficulties Questionnaire, direct observation of ADHD behaviors during Child's Solo Play, observation of parent-child interaction, parent sense of competence, and family stress. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of nonpharmacological treatments.

Conclusions: The trial will provide evidence as to whether NFPP is a more effective treatment for preschool ADHD than the treatment usually offered in everyday clinical practice.

Trial registration: ClinicalTrials.gov NCT01684644; https://ichgcp.net/clinical-trials-registry/NCT01684644?term= NCT01684644&rank=1 (Archived by WebCite at http://www.webcitation/6eOOAe8Qe).

Keywords: ADHD; RCT, clinical; TAU; child; multi-centre; non-pharmacological; parent training; parents; preschool; psycho-social; psychological; treatment.

Conflict of interest statement

Conflicts of Interest: ES-B and DD are the original codevelopers of the NFPP and benefit from royalties from the self-help version of the program.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of recruitment. Child mental health services (CAMHS); attention deficit/hyperactivity-disorder (ADHD); Development and Well-Being Assessment (DAWBA); New Forest Parenting Programme (NFPP); treatment as usual (TAU); T2 (week 12, post intervention); and T3 (6 month follow/up).

References

    1. Sonuga-Barke EJ, Daley D, Thompson M, Laver-Bradbury C, Weeks A. Parent-based therapies for preschool attention-deficit/hyperactivity disorder: A randomized, controlled trial with a community sample. J Am Acad Child Adolesc Psychiatry. 2001 Apr;40(4):402–408. doi: 10.1097/00004583-200104000-00008.
    1. Sonuga-Barke Edmund J S. Halperin JM. Developmental phenotypes and causal pathways in attention deficit/hyperactivity disorder: Potential targets for early intervention? J Child Psychol Psychiatry. 2010 Apr;51(4):368–389. doi: 10.1111/j.1469-7610.2009.02195.x.
    1. Wichstrøm Lars, Berg-Nielsen TS, Angold A, Egger HL, Solheim E, Sveen TH. Prevalence of psychiatric disorders in preschoolers. J Child Psychol Psychiatry. 2012 Jun;53(6):695–705. doi: 10.1111/j.1469-7610.2011.02514.x.
    1. Goodman R, Ford T, Richards H, Gatward R, Meltzer H. The development and well-being assessment: Description and initial validation of an integrated assessment of child and adolescent psychopathology. J Child Psychol Psychiatry. 2000 Jul;41(5):645–655.
    1. Lavigne JV, Gibbons RD, Christoffel KK, Arend R, Rosenbaum D, Binns H, Dawson N, Sobel H, Isaacs C. Prevalence rates and correlates of psychiatric disorders among preschool children. J Am Acad Child Adolesc Psychiatry. 1996 Feb;35(2):204–214. doi: 10.1097/00004583-199602000-00014.
    1. Lavigne JV, Lebailly SA, Hopkins J, Gouze KR, Binns HJ. The prevalence of ADHD, ODD, depression, and anxiety in a community sample of 4-year-olds. J Clin Child Adolesc Psychol. 2009 May;38(3):315–328. doi: 10.1080/15374410902851382.
    1. Greenhill LL, Posner K, Vaughan BS, Kratochvil CJ. Attention deficit hyperactivity disorder in preschool children. Child Adolesc Psychiatr Clin N Am. 2008 Apr;17(2):347–366, ix. doi: 10.1016/j.chc.2007.11.004.
    1. Pelham WE, Milich R. Peer relations in children with hyperactivity/attention deficit disorder. J Learn Disabil. 1984 Nov;17(9):560–567.
    1. Wehmeier PM, Schacht A, Barkley RA. Social and emotional impairment in children and adolescents with ADHD and the impact on quality of life. J Adolesc Health. 2010 Mar;46(3):209–217. doi: 10.1016/j.jadohealth.2009.09.009.
    1. DuPaul GJ, McGoey KE, Eckert TL, VanBrakle J. Preschool children with attention-deficit/hyperactivity disorder: Impairments in behavioral, social, and school functioning. J Am Acad Child Adolesc Psychiatry. 2001 May;40(5):508–515. doi: 10.1097/00004583-200105000-00009.
    1. Gardner DM, Gerdes AC. A review of peer relationships and friendships in youth with ADHD. J Atten Disord. 2015 Oct;19(10):844–855. doi: 10.1177/1087054713501552.
    1. Daley D, Birchwood J. ADHD and academic performance: Why does ADHD impact on academic performance and what can be done to support ADHD children in the classroom? Child Care Health Dev. 2010 Jul;36(4):455–464. doi: 10.1111/j.1365-2214.2009.01046.x.
    1. Sonuga-Barke Edmund J S. Dalen L, Daley D, Remington B. Are planning, working memory, and inhibition associated with individual differences in preschool ADHD symptoms? Dev Neuropsychol. 2002;21(3):255–272. doi: 10.1207/S15326942DN2103_3.
    1. DuPaul GJ, Gormley MJ, Laracy SD. School-based interventions for elementary school students with ADHD. Child Adolesc Psychiatr Clin N Am. 2014 Oct;23(4):687–697. doi: 10.1016/j.chc.2014.05.003.
    1. Lee SS, Lahey BB, Owens EB, Hinshaw SP. Few preschool boys and girls with ADHD are well-adjusted during adolescence. J Abnorm Child Psychol. 2008 Apr;36(3):373–383. doi: 10.1007/s10802-007-9184-6.
    1. Biederman J, Petty CR, Evans M, Small J, Faraone SV. How persistent is ADHD? A controlled 10-year follow-up study of boys with ADHD. Psychiatry Res. 2010 May 30;177(3):299–304. doi: 10.1016/j.psychres.2009.12.010.
    1. Lahey BB, Pelham WE, Loney J, Kipp H, Ehrhardt A, Lee SS, Willcutt EG, Hartung CM, Chronis A, Massetti G. Three-year predictive validity of DSM-IV attention deficit hyperactivity disorder in children diagnosed at 4-6 years of age. Am J Psychiatry. 2004 Nov;161(11):2014–2020. doi: 10.1176/appi.ajp.161.11.2014.
    1. Chorozoglou M, Smith E, Koerting J, Thompson MJ, Sayal K, Sonuga-Barke Edmund J S Preschool hyperactivity is associated with long-term economic burden: Evidence from a longitudinal health economic analysis of costs incurred across childhood, adolescence and young adulthood. J Child Psychol Psychiatry. 2015 Sep;56(9):966–975. doi: 10.1111/jcpp.12437.
    1. Kvist AP, Nielsen HS, Simonsen M. The importance of children's ADHD for parents' relationship stability and labor supply. Soc Sci Med. 2013 Jul;88:30–38. doi: 10.1016/j.socscimed.2013.04.001.
    1. Uchida M, Spencer TJ, Faraone SV, Biederman J. Adult outcome of ADHD: An overview of results from the MGH longitudinal family studies of pediatrically and psychiatrically referred youth with and without ADHD of both sexes. J Atten Disord. 2015 Sep 22; doi: 10.1177/1087054715604360.
    1. Subcommittee on Attention-Deficit/Hyperactivity Disorder. Steering Committee on Quality Improvement and Management. Wolraich M, Brown L, Brown RT, DuPaul G, Earls M, Feldman HM, Ganiats TG, Kaplanek B, Meyer B, Perrin J, Pierce K, Reiff M, Stein MT, Visser S. ADHD: Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011 Nov;128(5):1007–1022. doi: 10.1542/peds.2011-2654.
    1. Kendall T, Taylor E, Perez A, Taylor C, Guideline DG. Diagnosis and management of attention-deficit/hyperactivity disorder in children, young people, and adults: Summary of NICE guidance. BMJ. 2008;337:a1239.
    1. Greenhill L, Kollins S, Abikoff H, McCracken J, Riddle M, Swanson J, McGough J, Wigal S, Wigal T, Vitiello B, Skrobala A, Posner K, Ghuman J, Cunningham C, Davies M, Chuang S, Cooper T. Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284–1293. doi: 10.1097/01.chi.0000235077.32661.61.
    1. Charach A, Carson P, Fox S, Ali MU, Beckett J, Lim CG. Interventions for preschool children at high risk for ADHD: A comparative effectiveness review. Pediatrics. 2013 May;131(5):e1584–1604. doi: 10.1542/peds.2012-0974.
    1. Sonuga-Barke Edmund J S. Brandeis D, Cortese S, Daley D, Ferrin M, Holtmann M, Stevenson J, Danckaerts M, van der Oord Saskia. Döpfner Manfred, Dittmann RW, Simonoff E, Zuddas A, Banaschewski T, Buitelaar J, Coghill D, Hollis C, Konofal E, Lecendreux M, Wong Ian C K. Sergeant J, European ADHD Guidelines Group Nonpharmacological interventions for ADHD: Systematic review and meta-analyses of randomized controlled trials of dietary and psychological treatments. Am J Psychiatry. 2013 Mar;170(3):275–289. doi: 10.1176/appi.ajp.2012.12070991.
    1. Thompson Margaret J J. Laver-Bradbury C, Ayres M, Le PE, Mead S, Dodds C, Psychogiou L, Bitsakou P, Daley D, Weeks A, Brotman LM, Abikoff H, Thompson P, Sonuga-Barke Edmund J S A small-scale randomized controlled trial of the revised new forest parenting programme for preschoolers with attention deficit hyperactivity disorder. Eur Child Adolesc Psychiatry. 2009 Oct;18(10):605–616. doi: 10.1007/s00787-009-0020-0.
    1. Santucci LC, Thomassin K, Petrovic L, Weisz JR. Building evidence-based interventions for the youth, providers, and contexts of real-world mental-health care. Child Dev Perspect. 2015 Apr 11;9(2):67–73. doi: 10.1111/cdep.12118.
    1. Barwick M, Boydell K, Stasiulis E, Ferguson H, Blase K, Fixsen D. Ontario Canada: Children's Mental Health Ontario. [2016-01-09]. Knowledge transfer and implementation of evidence-based practices in childrens mental health .
    1. Weisz JR, Gray JS. Evidence-based psychotherapy for children and adolescents: Data from the present and a model for the future. Child Adolesc Ment Health. 2008 May;13(2):54–65. doi: 10.1111/j.1475-3588.2007.00475.x.
    1. Goodman R. Report. London: [2016-01-09]. Assessing preschool childrens emotional and behavioural adjustment .
    1. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: Explanation and elaboration. Ann Intern Med. 2008 Feb 19;148(4):295–309.
    1. Datamanagement Unit. . Central Denmark Region, Oluf Palmes Allé 15, 8200 Aarhus N, Denmark: Datamanagement Unit; 2012. [2016-01-12]. Trialpartner .
    1. Kazdin A. Research design in clinical psychology: Pearson New International Edition. Harlow, Essex: Pearson Education, Limited; 2013. p. 9781292042787.
    1. Coates J, Taylor JA, Sayal K. Parenting interventions for ADHD: A systematic literature review and meta-analysis. J Atten Disord. 2015 Oct;19(10):831–843. doi: 10.1177/1087054714535952.
    1. Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155–159.
    1. van den Hoofdakker Barbara J. van der Veen-Mulders Lianne. Sytema S, Emmelkamp Paul M G. Minderaa RB, Nauta MH. Effectiveness of behavioral parent training for children with ADHD in routine clinical practice: A randomized controlled study. J Am Acad Child Adolesc Psychiatry. 2007 Oct;46(10):1263–1271. doi: 10.1097/chi.0b013e3181354bc2.
    1. McCann DC, Thompson M, Daley D, Barton J, Laver-Bradbury C, Hutchings J, Coghill D, Stanton L, Maishman T, Dixon L, Caddy J, Chorozoglou M, Raftery J, Sonuga-Barke E. Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD. Trials. 2014;15:142. doi: 10.1186/1745-6215-15-142.
    1. McGoey KE, DuPaul GJ, Haley E, Shelton TL. Parent and teacher ratings of attention-deficit/hyperactivity disorder in preschool: The ADHD rating scale-IV preschool version. J Psychopathol Behav Assess. 2007 Jun 28;29(4):269–276. doi: 10.1007/s10862-007-9048-y.
    1. Goodman R. The extended version of the strengths and difficulties questionnaire as a guide to child psychiatric caseness and consequent burden. J Child Psychol Psychiatry. 1999 Jul;40(5):791–799.
    1. Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, Howes MJ, Jin R, Secnik K, Spencer T, Ustun TB, Walters EE. The World Health Organization adult ADHD self-report scale (ASRS): A short screening scale for use in the general population. Psychol Med. 2005 Feb;35(2):245–256.
    1. Johnston C, Mash E. A measure of parenting satisfaction and efficacy. Journal of Clinical Child Psychology. 1989 Jun;18(2):167–175. doi: 10.1207/s15374424jccp1802_8.
    1. Riley AW, Lyman LM, Spiel G, Döpfner Manfred, Lorenzo MJ, Ralston SJ. The family strain index (FSI). Reliability, validity, and factor structure of a brief questionnaire for families of children with ADHD. Eur Child Adolesc Psychiatry. 2006 Dec;15 Suppl 1:I72–78. doi: 10.1007/s00787-006-1010-0.
    1. Rush Aj. Handbook of psychiatric measures. Washington, DC: American Psychiatric Association; 2000. Symptom-specific measures for disorders usually first diagnosed in infancy, childhood, or adolescence.
    1. Goldberg D. Manual of the general health questionnaire. UK: NFER; 1978.
    1. DuPaul G, Reid Robert, Anastopoulos Arthur D, Lambert Matthew C, Watkins Marley W, Power Thomas J. Parent and teacher ratings of attention-deficit/hyperactivity disorder symptoms: Factor structure and normative data. Psychol Assess. 2016 Feb;28(2):214–225. doi: 10.1037/pas0000166.
    1. Diagnostic and statistical manual of mental disorders: DSM-IV. Washington, DC: American Psychiatric Association; 2000.
    1. Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976) 2000 Dec 15;25(24):3186–3191.
    1. Gilmore L, Cuskelly M. Factor structure of the parenting sense of competence scale using a normative sample. Child Care Health Dev. 2009 Jan;35(1):48–55. doi: 10.1111/j.1365-2214.2008.00867.x.
    1. Vostanis P. Strengths and difficulties questionnaire: Research and clinical applications. Curr Opin Psychiatry. 2006 Jul;19(4):367–372. doi: 10.1097/01.yco.0000228755.72366.05.
    1. Stone LL, Otten R, Engels Rutger C M E. Vermulst AA, Janssens Jan M A M Psychometric properties of the parent and teacher versions of the strengths and difficulties questionnaire for 4- to 12-year-olds: A review. Clin Child Fam Psychol Rev. 2010 Sep;13(3):254–274. doi: 10.1007/s10567-010-0071-2.
    1. Niclasen J, Teasdale TW, Andersen AN, Skovgaard AM, Elberling H, Obel C. Psychometric properties of the Danish strength and difficulties questionnaire: The SDQ assessed for more than 70,000 raters in four different cohorts. PLoS One. 2012;7(2):e32025. doi: 10.1371/journal.pone.0032025.
    1. Rimvall MK, Elberling H, Rask CU, Helenius D, Skovgaard AM, Jeppesen P. Predicting ADHD in school age when using the strengths and difficulties questionnaire in preschool age: A longitudinal general population study, CCC2000. Eur Child Adolesc Psychiatry. 2014 Nov;23(11):1051–1060. doi: 10.1007/s00787-014-0546-7.
    1. Croft S, Stride C, Maughan B, Rowe R. Validity of the strengths and difficulties questionnaire in preschool-aged children. Pediatrics. 2015 May;135(5):e1210–1219. doi: 10.1542/peds.2014-2920.
    1. Kessler RC, Adler LA, Gruber MJ, Sarawate CA, Spencer T, Van Brunt David L Validity of the World Health Organization adult ADHD self-report scale (ASRS) screener in a representative sample of health plan members. Int J Methods Psychiatr Res. 2007;16(2):52–65. doi: 10.1002/mpr.208.
    1. Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: Results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716–723. doi: 10.1176/ajp.2006.163.4.716.
    1. Szomlaiski N, Dyrborg J, Rasmussen H, Schumann T, Koch SV, Bilenberg N. Validity and clinical feasibility of the ADHD rating scale (ADHD-RS) A Danish nationwide multicenter study. Acta Paediatr. 2009 Feb;98(2):397–402. doi: 10.1111/j.1651-2227.2008.01025.x.
    1. Sonuga-Barke Edmund J S. Daley D, Thompson M. Does maternal ADHD reduce the effectiveness of parent training for preschool children's ADHD? J Am Acad Child Adolesc Psychiatry. 2002 Jun;41(6):696–702. doi: 10.1097/00004583-200206000-00009.
    1. Reyno SM, McGrath PJ. Predictors of parent training efficacy for child externalizing behavior problems--a meta-analytic review. J Child Psychol Psychiatry. 2006 Jan;47(1):99–111. doi: 10.1111/j.1469-7610.2005.01544.x.
    1. Ghuman J, Ghuman H. ADHD in preschool children. New York: Oxford University Press; 2014. p. 9780199948925.
    1. Weisz JR, Krumholz LS, Santucci L, Thomassin K, Ng MY. Shrinking the gap between research and practice: Tailoring and testing youth psychotherapies in clinical care contexts. Annu Rev Clin Psychol. 2015;11:139–163. doi: 10.1146/annurev-clinpsy-032814-112820.
    1. Daley D, Jacobsen R, Lange A-M, Sorensen A, Walldorf J. Costing adult attention deficit hyperactivity disorder: Impact on the individual and society. New York: Oxford University Press; 2015. p. 0198745559.
    1. Halperin JM, Bédard Anne-Claude V, Curchack-Lichtin JT. Preventive interventions for ADHD: A neurodevelopmental perspective. Neurotherapeutics. 2012 Jul;9(3):531–541. doi: 10.1007/s13311-012-0123-z.

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