Loading search results
Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
Sponsor study identifier
interventional
108
0 countries
N/A
Study Start
March 1, 2014
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2014
Actual (reported)December 13, 2018
Actual (reported)December 19, 2018
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)CGI-S/CGI-I change
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.
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
ODD Scale change
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
SNAP-IV change
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
FBIM change
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
ECBI change
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
RPQ change
Baseline, post-treatment/control period (3 months), 6 months and 1 year post-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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Johnson M, Gillberg C, Vinsa I, Fransson G, Samuelsson L, Jakobsson K, Ostlund S, Fernell E, Gillberg C. A randomized controlled trial of a new intervention in early symptomatic syndromes eliciting neurodevelopmental clinical examinations: PR-ESSENCE. Eur Child Adolesc Psychiatry. 2023 Jan;32(1):63-74. doi: 10.1007/s00787-021-01837-z. Epub 2021 Jul 3.
Christopher Gillberg, Professor
Gillberg Neuropsychiatry Centre, Goteborg University
108 participants (actual enrollment reported by the registry).
First Submitted
December 13, 2018
First Posted
December 19, 2018
Study Start
Contact the study team to confirm eligibility.
March 1, 2014
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
July 31, 2020
Record last verified: 2020-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: