NCT05221515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

7.8 years

First QC Date

November 23, 2021

Last Update Submit

February 2, 2022

Conditions

Keywords

Autism spectrum disorderAngerRandomized controlled trial

Outcome Measures

Primary Outcomes (8)

  • Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence

    Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.

    At week 0, before the intervention group received treatment

  • Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence

    Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.

    9 weeks later after treatment

  • Aggressive behavior problems: aggression as reported by parent

    The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.

    At week 0, before the intervention group received treatment

  • Aggressive behavior problems: aggression as reported by parent

    The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.

    9 weeks later after treatment

  • Aggressive behavior problems: aggression as reported by teacher

    The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.

    At week 0, before the intervention group received treatment

  • Aggressive behavior problems: aggression as reported by teacher

    The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.

    9 weeks later after treatment

  • Anger coping strategies

    The Behavioral Anger Response Questionnaire for children (BARQ-C)

    At week 0, before the intervention group received treatment

  • Anger coping strategies

    The Behavioral Anger Response Questionnaire for children (BARQ-C)

    9 weeks later after treatment

Secondary Outcomes (8)

  • Quality of life of the child

    At week 0, before the intervention group received treatment

  • Quality of life of the child

    9 weeks later after treatment

  • Social impairment due to autism symptoms

    At week 0, before the intervention group received treatment

  • Social impairment due to autism symptoms

    9 weeks later after treatment

  • Parental stress

    At week 0, before the intervention group received treatment

  • +3 more secondary outcomes

Study Arms (2)

Intervention condition

EXPERIMENTAL

Participants received both parent training and child-focussed treatment

Behavioral: Anger can go!Behavioral: Parent psycho-education

Control condition

ACTIVE COMPARATOR

Participants received only parent training

Behavioral: Parent psycho-education

Interventions

Anger can go!BEHAVIORAL

The intervention "Anger Can Go!" was designed to treat anger regulation problems in autistic children aged 8 to 13 years old. The intervention consists of nine sessions of 60 minutes and is divided in four phases. Phase 1: psycho-education, affect-education and measuring anger with an anger-thermometer. This is a self-report scale presented as the drawing of a thermometer, that allows the child to indicate his level of anger, as linked to specific bodily and behavioral representations on a scale from 0 to 3. Phase 2: making a functional behavior assessment (FBA) and taking a time-out at a low anger-level (between 1 and 2 on the scale 0 to 3) to prevent aggressive outbursts. Phase 3: taking a time-out at a low anger-level (between 1 and 2 on the scale 0 to 3) to prevent aggressive outbursts, shifting attention away from aversive stimuli, to cope with the stress of the anger provoking situation. Phase 4: creating solutions to cope with an anger provoking situation.

Intervention condition

Three psycho-educational parent group sessions (take place before the children's sessions in intervention group). Parents meet with other parents and a therapist to learn about the nature of their Expressed Emotion (EE) and how it relates to the child's aggressive behavior.

Control conditionIntervention condition

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • psychotropic medication still being set

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

De Bascule

Amsterdam, North Holland, Netherlands

Location

Wei43

Amsterdam, Netherlands

Location

Related Publications (35)

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    BACKGROUND
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    BACKGROUND
  • 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.

    PMID: 31502871BACKGROUND
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    PMID: 20960041BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24104515BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27095831BACKGROUND
  • 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.

    PMID: 25221619BACKGROUND
  • 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.

    PMID: 16134028BACKGROUND
  • 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.

    PMID: 24362795BACKGROUND
  • 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.

    PMID: 25442191BACKGROUND
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    BACKGROUND
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    PMID: 17082978BACKGROUND
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    PMID: 25578338BACKGROUND
  • 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.

    PMID: 19568924BACKGROUND
  • 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.

    PMID: 20091348BACKGROUND
  • 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.

    PMID: 19309326BACKGROUND
  • 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.

  • 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.

  • 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.

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  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Frits Boer, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2021

First Posted

February 3, 2022

Study Start

January 1, 2011

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations