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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05221515
Other study ID # BOBpaper2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2011
Est. completion date October 30, 2018

Study information

Verified date February 2022
Source VU University of Amsterdam
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date October 30, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 13 Years
Eligibility Inclusion Criteria: - Primary diagnosis of autism spectrum disorder - age 8 - 13 - seeking treatment for aggressive behaviour problems Exclusion Criteria: - psychotropic medication still being set

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands De Bascule Amsterdam Noord-Holland
Netherlands Wei43 Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

References & Publications (35)

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Fernandez-Alcántara M, García-Caro MP, Pérez-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. — View 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. Review. — View 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. Review. — View Citation

Gross, J. J. (2015). Emotion regulation: Current status and future prospects. Psychological inquiry, 26(1), 1-26.

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. — View 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. — View 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. — View 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. — View Citation

Linehan, M. (2014). DBT? Skills training manual. Guilford Publications.

Luiselli, J. K. (Ed.). (2014). Children and youth with autism spectrum disorder (ASD): recent advances and innovations in assessment, education, and intervention.

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.

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. — View 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.

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. — View 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. — View Citation

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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 — View Citation

* Note: There are 35 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Anger coping strategies The Behavioral Anger Response Questionnaire for children (BARQ-C) At week 0, before the intervention group received treatment
Primary Anger coping strategies The Behavioral Anger Response Questionnaire for children (BARQ-C) 9 weeks later after treatment
Secondary Quality of life of the child Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. At week 0, before the intervention group received treatment
Secondary Quality of life of the child Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning. 9 weeks later after treatment
Secondary Social impairment due to autism symptoms Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments. At week 0, before the intervention group received treatment
Secondary Social impairment due to autism symptoms Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments. 9 weeks later after treatment
Secondary Parental stress Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress At week 0, before the intervention group received treatment
Secondary Parental stress Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress 9 weeks later after treatment
Secondary Parental well-being Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being. At week 0, before the intervention group received treatment
Secondary Parental well-being Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being. 9 weeks later after treatment
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