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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Anger can go!
Parent psycho-education
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism spectrum disorder, Anger, Randomized controlled trial

Eligibility Criteria

8 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • psychotropic medication still being set

Sites / Locations

  • De Bascule
  • Wei43

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention condition

Control condition

Arm Description

Participants received both parent training and child-focussed treatment

Participants received only parent training

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life of the child
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Quality of life of the child
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Social impairment due to autism symptoms
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Social impairment due to autism symptoms
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Parental stress
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Parental stress
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Parental well-being
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
Parental well-being
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.

Full Information

First Posted
November 23, 2021
Last Updated
February 2, 2022
Sponsor
VU University of Amsterdam
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1. Study Identification

Unique Protocol Identification Number
NCT05221515
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism spectrum disorder, Anger, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention condition
Arm Type
Experimental
Arm Description
Participants received both parent training and child-focussed treatment
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
Participants received only parent training
Intervention Type
Behavioral
Intervention Name(s)
Anger can go!
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Parent psycho-education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
Description
Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.
Time Frame
At week 0, before the intervention group received treatment
Title
Aggressive behavior problems: Arguing, Temper tantrums, Destroying things and Physical violence
Description
Questionnaire Social Behavior (QSB) measuring behavioral and emotion regulation problems typical for autistic children.
Time Frame
9 weeks later after treatment
Title
Aggressive behavior problems: aggression as reported by parent
Description
The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Time Frame
At week 0, before the intervention group received treatment
Title
Aggressive behavior problems: aggression as reported by parent
Description
The aggression sub scale from the Child Behavior Checklist (CBCL). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Time Frame
9 weeks later after treatment
Title
Aggressive behavior problems: aggression as reported by teacher
Description
The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Time Frame
At week 0, before the intervention group received treatment
Title
Aggressive behavior problems: aggression as reported by teacher
Description
The aggression sub scale from the Teacher Rating Form (TRF). Minimum value: 0, maximum value: 36. A higher score means more aggression.
Time Frame
9 weeks later after treatment
Title
Anger coping strategies
Description
The Behavioral Anger Response Questionnaire for children (BARQ-C)
Time Frame
At week 0, before the intervention group received treatment
Title
Anger coping strategies
Description
The Behavioral Anger Response Questionnaire for children (BARQ-C)
Time Frame
9 weeks later after treatment
Secondary Outcome Measure Information:
Title
Quality of life of the child
Description
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Time Frame
At week 0, before the intervention group received treatment
Title
Quality of life of the child
Description
Pediatric Quality of life inventory (Peds ql): Physical Functioning, Emotional Functioning, Social Functioning and School Functioning.
Time Frame
9 weeks later after treatment
Title
Social impairment due to autism symptoms
Description
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Time Frame
At week 0, before the intervention group received treatment
Title
Social impairment due to autism symptoms
Description
Social Responsiveness Scale (SRS). Minimum value: 0, maximum value: 195. A higher score means more impairments.
Time Frame
9 weeks later after treatment
Title
Parental stress
Description
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Time Frame
At week 0, before the intervention group received treatment
Title
Parental stress
Description
Nijmeegse Ouderlijke Stress Index (NOSI). Minimum value: 6, maximum value: 66. A higher score means more stress
Time Frame
9 weeks later after treatment
Title
Parental well-being
Description
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
Time Frame
At week 0, before the intervention group received treatment
Title
Parental well-being
Description
Symptom Checklist-90 (SCL-90). Minimum value: 0, maximum value: 360. A higher score indicates a worse well-being.
Time Frame
9 weeks later after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits Boer, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Study Chair
Facility Information:
Facility Name
De Bascule
City
Amsterdam
State/Province
Noord-Holland
Country
Netherlands
Facility Name
Wei43
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems

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