PR-ESSENCE for Youth With Challenging Behavior

NCT03780413 | Completed

• 1 other identifier: GNC PR-ESSENCE
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Behavior Problem of Childhood and Adolescence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Study Arms (2)

PR-ESSENCE treatment

ACTIVE COMPARATOR

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

Control (TAU)

ACTIVE COMPARATOR

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)

Interventions

PR-ESSENCE treatment BEHAVIORAL

PR-ESSENCE treatment

Control (TAU) BEHAVIORAL

Control (TAU)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 5 to18 years with neuropsychiatric diagnoses and serious challenging behaviors/explosive reactions.
• Intellectual function in the normal range, according to WISC-test, adaptive function and clinical judgment.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Related Publications (1)

• 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.

  PMID: 34218336 DERIVED

Study Officials

• Christopher Gillberg, Professor

  Gillberg Neuropsychiatry Centre, Goteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: 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)

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: March 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share