Clinical trial NCT05221515: The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems
Official title: The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism spectrum disorder
Anger
Randomized controlled trial
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 51
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children on the autism spectrum often show aggressive behavior. Treatment can train children to be more aware of their emotions. Investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems.

Detailed description: Investigators studied the effectiveness of an attention-based intervention tailored on aggressive behavior problems and the use of anger coping strategies of school aged autistic children with anger regulation problems. Using a randomized controlled trial (RCT), children were allocated to the attention-based treatment in combination with a psycho-educational parent-training (treatment group) or to the parent-training only (active control group).

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of autism spectrum disorder
* age 8 - 13
* seeking treatment for aggressive behaviour problems

Exclusion Criteria:

* psychotropic medication still being set

Primary outcomes:
measure: Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
timeFrame: At week 0, before the intervention group received treatment
measure: Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
timeFrame: 9 weeks later after treatment
measure: Aggressive behavior problems: aggression as reported by parent
timeFrame: At week 0, before the intervention group received treatment
measure: Aggressive behavior problems: aggression as reported by parent
timeFrame: 9 weeks later after treatment
measure: Aggressive behavior problems: aggression as reported by teacher
timeFrame: At week 0, before the intervention group received treatment
measure: Aggressive behavior problems: aggression as reported by teacher
timeFrame: 9 weeks later after treatment
measure: Anger coping strategies
timeFrame: At week 0, before the intervention group received treatment
measure: Anger coping strategies
timeFrame: 9 weeks later after treatment
Secondary outcomes:
measure: Quality of life of the child
timeFrame: At week 0, before the intervention group received treatment
measure: Quality of life of the child
timeFrame: 9 weeks later after treatment
measure: Social impairment due to autism symptoms
timeFrame: At week 0, before the intervention group received treatment
measure: Social impairment due to autism symptoms
timeFrame: 9 weeks later after treatment
measure: Parental stress
timeFrame: At week 0, before the intervention group received treatment
measure: Parental stress
timeFrame: 9 weeks later after treatment
measure: Parental well-being
timeFrame: At week 0, before the intervention group received treatment
measure: Parental well-being
timeFrame: 9 weeks later after treatment
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: De Bascule
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Wei43
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Frits Boer, PhD
role: STUDY_CHAIR
References:
citation: Carr, E. G., & Horner, R. H. (2007). The expanding vision of positive behavior support: Research perspectives on happiness, helpfulness, hopefulness. Journal of positive behavior interventions, 9(1), 3-14.
citation: Chalfant AM, Rapee R, Carroll L. Treating anxiety disorders in children with high functioning autism spectrum disorders: a controlled trial. J Autism Dev Disord. 2007 Nov;37(10):1842-57. doi: 10.1007/s10803-006-0318-4. Epub 2006 Dec 15.
citation: Fung LK, Mahajan R, Nozzolillo A, Bernal P, Krasner A, Jo B, Coury D, Whitaker A, Veenstra-Vanderweele J, Hardan AY. Pharmacologic Treatment of Severe Irritability and Problem Behaviors in Autism: A Systematic Review and Meta-analysis. Pediatrics. 2016 Feb;137 Suppl 2:S124-35. doi: 10.1542/peds.2015-2851K.
citation: Goel R, Hong JS, Findling RL, Ji NY. An update on pharmacotherapy of autism spectrum disorder in children and adolescents. Int Rev Psychiatry. 2018 Feb;30(1):78-95. doi: 10.1080/09540261.2018.1458706. Epub 2018 Apr 25.
citation: Gross, J. J. (2015). Emotion regulation: Current status and future prospects. Psychological inquiry, 26(1), 1-26.
citation: Hartmann K, Urbano MR, Raffaele CT, Kreiser NL, Williams TV, Qualls LR, Elkins DE. Outcomes of an emotion regulation intervention group in young adults with autism spectrum disorder. Bull Menninger Clin. 2019 Summer;83(3):259-277. doi: 10.1521/bumc.2019.83.3.259.
citation: Ibrahim K, Kalvin C, Marsh CL, Anzano A, Gorynova L, Cimino K, Sukhodolsky DG. Anger Rumination is Associated with Restricted and Repetitive Behaviors in Children with Autism Spectrum Disorder. J Autism Dev Disord. 2019 Sep;49(9):3656-3668. doi: 10.1007/s10803-019-04085-y.
citation: Kanne SM, Mazurek MO. Aggression in children and adolescents with ASD: prevalence and risk factors. J Autism Dev Disord. 2011 Jul;41(7):926-37. doi: 10.1007/s10803-010-1118-4.
citation: Linehan, M. (2014). DBT? Skills training manual. Guilford Publications.
citation: Luiselli, J. K. (Ed.). (2014). Children and youth with autism spectrum disorder (ASD): recent advances and innovations in assessment, education, and intervention.
citation: Mascha, K., & Boucher, J. (2006). Preliminary investigation of a qualitative method of examining siblings' experiences of living with a child with ASD. The British Journal of Development Disabilities, 52(102), 19-28.
citation: McStay RL, Dissanayake C, Scheeren A, Koot HM, Begeer S. Parenting stress and autism: the role of age, autism severity, quality of life and problem behaviour of children and adolescents with autism. Autism. 2014 Jul;18(5):502-10. doi: 10.1177/1362361313485163. Epub 2013 Oct 8.
citation: Mazurek, M. O., Kanne, S. M., & Wodka, E. L. (2013). Physical aggression in children and adolescents with autism spectrum disorders. Research in Autism Spectrum Disorders, 7(3), 455-465.
citation: Patel S, Day TN, Jones N, Mazefsky CA. Association between anger rumination and autism symptom severity, depression symptoms, aggression, and general dysregulation in adolescents with autism spectrum disorder. Autism. 2017 Feb;21(2):181-189. doi: 10.1177/1362361316633566. Epub 2016 Jul 9.
citation: Hill AP, Zuckerman KE, Hagen AD, Kriz DJ, Duvall SW, van Santen J, Nigg J, Fair D, Fombonne E. Aggressive Behavior Problems in Children with Autism Spectrum Disorders: Prevalence and Correlates in a Large Clinical Sample. Res Autism Spectr Disord. 2014 Sep 1;8(9):1121-1133. doi: 10.1016/j.rasd.2014.05.006.
citation: Reese RM, Richman DM, Belmont JM, Morse P. Functional characteristics of disruptive behavior in developmentally disabled children with and without autism. J Autism Dev Disord. 2005 Aug;35(4):419-28. doi: 10.1007/s10803-005-5032-0.
citation: Samson AC, Phillips JM, Parker KJ, Shah S, Gross JJ, Hardan AY. Emotion dysregulation and the core features of autism spectrum disorder. J Autism Dev Disord. 2014 Jul;44(7):1766-72. doi: 10.1007/s10803-013-2022-5.
citation: Samson AC, Wells WM, Phillips JM, Hardan AY, Gross JJ. Emotion regulation in autism spectrum disorder: evidence from parent interviews and children's daily diaries. J Child Psychol Psychiatry. 2015 Aug;56(8):903-13. doi: 10.1111/jcpp.12370. Epub 2014 Dec 1.
citation: Segal, Z. V., Williams, J. M. G., & Teasdale, J. D. (2013). Mindfulness-based cognitive therapy for depression. Guilford Publications.
citation: Sofronoff K, Attwood T, Hinton S, Levin I. A randomized controlled trial of a cognitive behavioural intervention for anger management in children diagnosed with Asperger syndrome. J Autism Dev Disord. 2007 Aug;37(7):1203-14. doi: 10.1007/s10803-006-0262-3.
citation: Wong C, Odom SL, Hume KA, Cox AW, Fettig A, Kucharczyk S, Brock ME, Plavnick JB, Fleury VP, Schultz TR. Evidence-Based Practices for Children, Youth, and Young Adults with Autism Spectrum Disorder: A Comprehensive Review. J Autism Dev Disord. 2015 Jul;45(7):1951-66. doi: 10.1007/s10803-014-2351-z.
citation: White SW, Ollendick T, Scahill L, Oswald D, Albano AM. Preliminary efficacy of a cognitive-behavioral treatment program for anxious youth with autism spectrum disorders. J Autism Dev Disord. 2009 Dec;39(12):1652-62. doi: 10.1007/s10803-009-0801-9. Epub 2009 Jun 30.
citation: White SW, Albano AM, Johnson CR, Kasari C, Ollendick T, Klin A, Oswald D, Scahill L. Development of a cognitive-behavioral intervention program to treat anxiety and social deficits in teens with high-functioning autism. Clin Child Fam Psychol Rev. 2010 Mar;13(1):77-90. doi: 10.1007/s10567-009-0062-3.
citation: Wood JJ, Drahota A, Sze K, Har K, Chiu A, Langer DA. Cognitive behavioral therapy for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Child Psychol Psychiatry. 2009 Mar;50(3):224-34. doi: 10.1111/j.1469-7610.2008.01948.x.
citation: Bos MGN, Diamantopoulou S, Stockmann L, Begeer S, Rieffe C. Emotion Control Predicts Internalizing and Externalizing Behavior Problems in Boys With and Without an Autism Spectrum Disorder. J Autism Dev Disord. 2018 Aug;48(8):2727-2739. doi: 10.1007/s10803-018-3519-8.
citation: Dempsey AG, Llorens A, Brewton C, Mulchandani S, Goin-Kochel RP. Emotional and behavioral adjustment in typically developing siblings of children with autism spectrum disorders. J Autism Dev Disord. 2012 Jul;42(7):1393-402. doi: 10.1007/s10803-011-1368-9.
citation: Fernandez-Alcantara M, Garcia-Caro MP, Perez-Marfil MN, Hueso-Montoro C, Laynez-Rubio C, Cruz-Quintana F. Feelings of loss and grief in parents of children diagnosed with autism spectrum disorder (ASD). Res Dev Disabil. 2016 Aug;55:312-21. doi: 10.1016/j.ridd.2016.05.007. Epub 2016 May 25.
citation: Mazefsky CA, Kao J, Oswald DP. Preliminary evidence suggesting caution in the use of psychiatric self-report measures with adolescents with high-functioning autism spectrum disorders. Res Autism Spectr Disord. 2011 Jan;5(1):164-174. doi: 10.1016/j.rasd.2010.03.006.
citation: Ridderinkhof A, de Bruin EI, Blom R, Bogels SM. Mindfulness-Based Program for Children with Autism Spectrum Disorder and Their Parents: Direct and Long-Term Improvements. Mindfulness (N Y). 2018;9(3):773-791. doi: 10.1007/s12671-017-0815-x. Epub 2017 Oct 6.
citation: Singh, N. N., Lancioni, G. E., Manikam, R., Winton, A. S., Singh, A. N., Singh, J., & Singh, A. D. (2011). A mindfulness-based strategy for self-management of aggressive behavior in adolescents with autism. Research in Autism Spectrum Disorders, 5(3), 1153-1158.
citation: Seymour M, Wood C, Giallo R, Jellett R. Fatigue, stress and coping in mothers of children with an autism spectrum disorder. J Autism Dev Disord. 2013 Jul;43(7):1547-54. doi: 10.1007/s10803-012-1701-y.
citation: Shivers CM, Jackson JB, McGregor CM. Functioning Among Typically Developing Siblings of Individuals with Autism Spectrum Disorder: A Meta-Analysis. Clin Child Fam Psychol Rev. 2019 Jun;22(2):172-196. doi: 10.1007/s10567-018-0269-2.
citation: Spek AA, van Ham NC, Nyklicek I. Mindfulness-based therapy in adults with an autism spectrum disorder: a randomized controlled trial. Res Dev Disabil. 2013 Jan;34(1):246-53. doi: 10.1016/j.ridd.2012.08.009. Epub 2012 Sep 8.
citation: Tanksale R, Sofronoff K, Sheffield J, Gilmour J. Evaluating the effects of a yoga-based program integrated with third-wave cognitive behavioral therapy components on self-regulation in children on the autism spectrum: A pilot randomized controlled trial. Autism. 2021 May;25(4):995-1008. doi: 10.1177/1362361320974841. Epub 2020 Nov 25.
citation: Zaidman-Zait A, Mirenda P, Duku E, Vaillancourt T, Smith IM, Szatmari P, Bryson S, Fombonne E, Volden J, Waddell C, Zwaigenbaum L, Georgiades S, Bennett T, Elsabaggh M, Thompson A. Impact of personal and social resources on parenting stress in mothers of children with autism spectrum disorder. Autism. 2017 Feb;21(2):155-166. doi: 10.1177/1362361316633033. Epub 2016 Jul 9.