Autism Spectrum DisorderNCT05221515
The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems
A study testing Anger can go! and Parent psycho-education in people with Autism Spectrum Disorder, run by VU University of Amsterdam at 2 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Anger can go! and Parent psycho-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Jan 2011to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Primary diagnosis of autism spectrum disorder
- age 8 - 13
- seeking treatment for aggressive behaviour problems
Who cannot join
- psychotropic medication still being set
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems: a Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Anger can go!, Parent psycho-education
- Keywords
- Autism spectrum disorder, Anger, Randomized controlled trial
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anger can go!Behavioural
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-educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Participants received both parent training and child-focussed treatment Receives: Behavioral: Anger can go!; Behavioral: Parent psycho-education |
| Control condition | Active comparator | Participants received only parent training Receives: Behavioral: Parent psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 weeks later after treatment
Anger coping strategies
The Behavioral Anger Response Questionnaire for children (BARQ-C)
Measured: At week 0, before the intervention group received treatment
Anger coping strategies
The Behavioral Anger Response Questionnaire for children (BARQ-C)
Measured: 9 weeks later after treatment
Secondary outcomes (8)
Quality of life of the child
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Measured: At week 0, before the intervention group received treatment
Quality of life of the child
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Measured: 9 weeks later after treatment
Social impairment due to autism symptoms
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Measured: At week 0, before the intervention group received treatment
Social impairment due to autism symptoms
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Measured: 9 weeks later after treatment
Parental stress
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Measured: At week 0, before the intervention group received treatment
Parental stress
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Measured: 9 weeks later after treatment
Parental well-being
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
Measured: At week 0, before the intervention group received treatment
Parental well-being
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
Measured: 9 weeks later after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Jan 2011
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sander Begeer, VU University of Amsterdam
- Investigators
- Frits Boer, PhD, Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221515
- Sponsor's protocol ID
- BOBpaper2021
- Status last verified
- Feb 2022
- First submitted
- 23 Nov 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 17171539Fung 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.
PubMed 26908468Goel 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.
PubMed 29693461Gross, 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.
PubMed 31502871Ibrahim 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.
PubMed 31144231Kanne 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.
PubMed 20960041Linehan, 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.
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.
PubMed 24104515Mazurek, 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.
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.
PubMed 27095831Hill 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.
PubMed 25221619
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05221515
- Acronym / sponsor ID
- BOBpaper2021
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Anger, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Anger can go!, Behavioral: Parent psycho-educationParticipants received both parent training and child-focussed treatment |
| Control condition | Active comparator | Behavioral: Parent psycho-educationParticipants received only parent training |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary diagnosis of autism spectrum disorder
- age 8 - 13
- seeking treatment for aggressive behaviour problems
Key exclusion criteria (1 listed)
- psychotropic medication still being set
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention condition |
| Parent psycho-educationThree 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. | Behavioural | Control condition, Intervention condition |
Primary outcome
Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
Time frame: At week 0, before the intervention group received treatment
Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.
Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
Time frame: 9 weeks later after treatment
Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.
Aggressive behavior problems: aggression as reported by parent
Time frame: At week 0, before the intervention group received treatment
The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Aggressive behavior problems: aggression as reported by parent
Time frame: 9 weeks later after treatment
The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Aggressive behavior problems: aggression as reported by teacher
Time frame: At week 0, before the intervention group received treatment
The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Aggressive behavior problems: aggression as reported by teacher
Time frame: 9 weeks later after treatment
The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Anger coping strategies
Time frame: At week 0, before the intervention group received treatment
The Behavioral Anger Response Questionnaire for children (BARQ-C)
Anger coping strategies
Time frame: 9 weeks later after treatment
The Behavioral Anger Response Questionnaire for children (BARQ-C)
8 secondary outcomes
Quality of life of the child
Time frame: At week 0, before the intervention group received treatment
Quality of life of the child
Time frame: 9 weeks later after treatment
Social impairment due to autism symptoms
Time frame: At week 0, before the intervention group received treatment
Social impairment due to autism symptoms
Time frame: 9 weeks later after treatment
Parental stress
Time frame: At week 0, before the intervention group received treatment
Parental stress
Time frame: 9 weeks later after treatment
Parental well-being
Time frame: At week 0, before the intervention group received treatment
Parental well-being
Time frame: 9 weeks later after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- BackgroundCarr, 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.
- Background: PubMed 17171539Chalfant 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.
- Background: PubMed 26908468Fung 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.
- Background: PubMed 29693461Goel 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.
- BackgroundGross, J. J. (2015). Emotion regulation: Current status and future prospects. Psychological inquiry, 26(1), 1-26.
- Background: PubMed 31502871Hartmann 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.
- Background: PubMed 31144231Ibrahim 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.
- Background: PubMed 20960041Kanne 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.
- BackgroundLinehan, M. (2014). DBT? Skills training manual. Guilford Publications.
- BackgroundLuiselli, J. K. (Ed.). (2014). Children and youth with autism spectrum disorder (ASD): recent advances and innovations in assessment, education, and intervention.
- BackgroundMascha, 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: PubMed 24104515McStay 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frits Boer, PhD study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anger can go! and Parent psycho-education in people with Autism Spectrum Disorder, run by VU University of Amsterdam at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence (time frame: At week 0, before the intervention group received treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05221515, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.