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Completed

NCT Number: NCT05221515

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

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.

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Key information

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

De Bascule, Amsterdam, North Holland, Netherlands

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • psychotropic medication still being set

Treatment and study plan

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.

Parent psycho-education

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Anger coping strategies

    Time frame: At week 0, before the intervention group received treatment

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

  8. Anger coping strategies

    Time frame: 9 weeks later after treatment

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Registry information

Official study title

The Effectiveness of an Attention-based Intervention for School Aged Autistic Children With Anger Regulating Problems: a Randomized Controlled Trial

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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