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Trial record 4 of 91 for:    adhd and autism

PR-ESSENCE for Youth With Challenging Behavior

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780413
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Mats Johnson, Göteborg University

Brief Summary:

The method "Collaborative and Proactive Solutions" (CPS) was developed by Dr. Ross Greene, Harvard University, to understand and help kids with social, emotional, and behavioral challenges. The underlying theory is that challenging behavior is caused by lagging cognitive skills, commonly in the domains of flexibility/adaptability, frustration tolerance, and problem-solving. Thus, challenging behavior can be seen as a form of developmental delay, and the most effective way for adults to help the children and to facilitate interaction with them is to understand the lagging skills behind the behavior and to change their own mindset accordingly.

ADHD and autism belong in a group of overlapping neurodevelopmental conditions now often referred to under the umbrella term of ESSENCE (Early Symptomatic Syndromes Eliciting Neurodevelopmental Clinical Examinations). A common impairing problem in both autism and ADHD - and in several of the other disorders in the group of ESSENCE (including Tourette syndrome and other tic disorders) - is the marked inability to control temper, coupled with oppositional-defiant behaviors.

The CPS-method has been evaluated by Ross Greene et al. in United States studies for families, in schools, and in institutions for young people with serious behavior problems. Our research group published the first Swedish study with the method in 2012, a small open pilot study. Based on experiences in clinical work after that study our group reached the conclusion that, in order for the intervention to be useful for families with severely impairing ESSENCE, the CPS model needed to be modified. After a number of research meetings and seminars, we therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE).

The present study is a randomized controlled trial for approximately 130 children and adolescents aged 5-18 years, with neuropsychiatric disorders (for instance Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Autism Spectrum Disorder (ASD), Tourette syndrome, learning difficulties), children who have been assessed at our Child Neuropsychiatry Clinic (CNC), and from the Habilitation Services, Child Psychiatry Units or schools in the Göteborg region.


Condition or disease Intervention/treatment Phase
Behavior Problem of Childhood and Adolescence Behavioral: PR-ESSENCE treatment Behavioral: Control (TAU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: RCT in which participants are randomized to active group (PR-ESSENCE for 10 weeks) or control group (treatment as usual for 10 weeks, followed PR-ESSENCE for 10 weeks)
Masking: Single (Outcomes Assessor)
Masking Description: Blinded assessors
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
Active Comparator: PR-ESSENCE treatment
The treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year.
Behavioral: PR-ESSENCE treatment
Active Comparator: Control (TAU)
The control group receives 10 weeks of "treatment as usual (TAU)" (that is the standard psychoeducation, support and treatment given to all youth after neuropsychiatric assessment at our clinic), followed by 10 weeks of PR-ESSENCE. Outcome measures were collected pre- and post-treatment, and after 6 months and one year.
Behavioral: Control (TAU)



Primary Outcome Measures :
  1. CGI-S/CGI-I change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Clinical Global Impression - Severity and Improvement (by blinded assessor). Range 1-7 points, lower is better. A global assessment of severity and change in behavior problems and everyday function.


Secondary Outcome Measures :
  1. ODD Scale change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Oppositional Defiant Rating Scale (Ross Greene's), parent-rated. An assessment of DSM-5 Oppositional Defiant Disorder symptoms. Range 34-170, lower is better.

  2. SNAP-IV change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.

  3. FBIM change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.

  4. ECBI change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.

  5. RPQ change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.

  6. Beck's Youth Inventory change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Self-rating of depression, anxiety, irritability, behavior problems, and self-image. Self-rated by interview. Range 0-300, lower is better.

  7. Problem solving scale change [ Time Frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment ]
    Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children and adolescents aged 5 to18 years with neuropsychiatric diagnoses and serious challenging behaviors/explosive reactions.
  2. Intellectual function in the normal range, according to WISC-test, adaptive function and clinical judgment.
  3. Participants treated with psychoactive medication (e.g. for ADHD) can be included if the medication has been unchanged during at least one month prior to baseline, and is unchanged during the treatment period.

Exclusion Criteria:

  1. Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that according to the investigators opinion makes study participation unsuitable.
  2. Substance Use.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780413


Sponsors and Collaborators
Göteborg University
Investigators
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Study Chair: Christopher Gillberg, Professor Gillberg Neuropsychiatry Centre, Goteborg University
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Responsible Party: Mats Johnson, MD PhD, Göteborg University
ClinicalTrials.gov Identifier: NCT03780413    
Other Study ID Numbers: GNC PR-ESSENCE
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms