The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems

February 2, 2022 updated by: Sander Begeer, VU University of Amsterdam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Wei43
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands
        • De Bascule

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention condition
Participants received both parent training and child-focussed treatment
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.
Behavioral: 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.
Active Comparator: Control condition
Participants received only parent training
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At week 0, before the intervention group received treatment
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.
9 weeks later after treatment
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.
At week 0, before the intervention group received treatment
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.
9 weeks later after treatment
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.
At week 0, before the intervention group received treatment
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.
9 weeks later after treatment
Anger coping strategies
Time Frame: At week 0, before the intervention group received treatment
The Behavioral Anger Response Questionnaire for children (BARQ-C)
At week 0, before the intervention group received treatment
Anger coping strategies
Time Frame: 9 weeks later after treatment
The Behavioral Anger Response Questionnaire for children (BARQ-C)
9 weeks later after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of the child
Time Frame: At week 0, before the intervention group received treatment
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
Quality of life of the child
Time Frame: 9 weeks later after treatment
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
9 weeks later after treatment
Social impairment due to autism symptoms
Time Frame: At week 0, before the intervention group received treatment
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
Social impairment due to autism symptoms
Time Frame: 9 weeks later after treatment
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
9 weeks later after treatment
Parental stress
Time Frame: At week 0, before the intervention group received treatment
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
Parental stress
Time Frame: 9 weeks later after treatment
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
9 weeks later after treatment
Parental well-being
Time Frame: At week 0, before the intervention group received treatment
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
Parental well-being
Time Frame: 9 weeks later after treatment
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
9 weeks later after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VU University of Amsterdam

Investigators

  • Study Chair: Frits Boer, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOBpaper2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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