RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes

March 5, 2026 updated by: Göteborg University

Randomized Controlled Study of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes

Randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes, including 60-70 youth. Inclusion criteria: Youth aged 12-17 years, staying at least 3 months at the home, with intellectual function in the normal range according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as measured by Broset Violence Checklist (BVC). Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition "treatment as usual". After the control period, the control group will receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed at baseline, post-treatment/control period, and 3-6 months post-treatment (at the time when the youth is planned to move from the home) with global assessments of problem severity and improvement by blinded rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. BVC ratings are also made daily by contact persons and teachers during the whole study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PR-ESSENCE is a problem-solving training program developed by our research team, inspired by Dr Greene´s model "Collaborative and Proactive Solutions (CPS)". We recently completed an RCT with PR-ESSENCE at the Gillberg Centre, Gothenburg University, including 108 children and adolescents who had complex neurodevelopmental disorders such as autism, ADHD, ODD, Tourette, learning difficulties etc and challenging behaviors. The study showed significant global improvements in behavior problems with a large effect size.

The PR-ESSENCE model is designed to train and develop mutual problem solving strategies for children and adolescents with neurodevelopmental disorders (ESSENCE, an umbrella term coined by Gillberg 2010 = Early Symptomatic Syndromes Eliciting Neuropsychiatric Clinical Examinations, which puts focus on the considerable overlap several of these syndromes have). Many youth who are placed in youth treatment homes due to challenging and risk-taking behaviors have been shown to have ESSENCE impairments.

The present study is a randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes in southwestern Sweden, Bjorkbacken (girls) and Nereby (boys). We plan to include 60-70 youth. Inclusion criteria: Youth aged 12-17 years, staying at least 3 months at the home, with intellectual function in the normal range according to WISC-test and clinical judgment, and exhibiting significant problem behaviors as measured by Broset Violence Checklist (BVC). Exclusion criteria: Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition which would make study participation unsuitable. Psychoactive medication is allowed if stable at least one month before baseline, and during the trial.

At baseline a medical and neuropsychiatric history is taken by psychologist and physician (a standard assessment done for all youth placed at the homes), including rating of history of risk behaviors with Youth Level of Service/Case Management Inventory (YLS/CMI), and a DSM-5-diagnostic screening (DSM-5-CCSM) for psychiatric symptoms. Intellectual level will be tested with WISC-V. The participants will do self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. The therapists interview parents/carers about history of neuropsychiatric symptoms with the A-TAC-interview.

Subjects are randomized to 10 weeks of PR-ESSENCE treatment or to the control condition "treatment as usual". After the control period, the control group will also receive 10 weeks of PR-ESSENCE treatment. Outcome is assessed at baseline, post treatment/control period, and 3-6 months post-treatment (at the time when the youth is planned to move from the home) with global assessments of problem severity and improvement by blinded independent rater (CGI-I, CGI-S), ratings of SNAP-IV (ADHD and oppositional symptoms), ECBI (behavior problems) and RPQ (relation problems) by the youth's contact person, and self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. BVC ratings are made daily by contact persons and teachers during the whole study. During treatment, therapists rate every week with a Problem Rating Scale how many problem situations are completely or partly solved.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • V. Gotaland
      • Gothenburg, V. Gotaland, Sweden, 411 19
        • Gillberg Neuropsychiatry Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls).
  2. Age 12-17 years
  3. Intellectual function in the normal range according to WISC-test and clinical judgment
  4. Problem behavior score of at least 5 points in one week on the Broset Violence Checklist (BVC). Score is measured during 2 weeks before screening
  5. Medium to high-risk score on the YLS/CMI behavior problem domain 7
  6. Psychotropic medication is allowed if stable during one month before baseline and during the randomized period of the trial

Exclusion Criteria:

1. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition that would make study participation unsuitable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PR-ESSENCE treatment
PR-ESSENCE treatment 10 weeks
Behavioral: PR-ESSENCE
Manual-based training of mutual problem-solving
Active Comparator: Control
Treatment as usual 10 weeks
Behavioral: Treatment as usual
General support in daily structure and activities that is given to all youth staying at the treatment homes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression- Improvement (CGI-I)
Time Frame: 10 weeks, change
Global rating of improvement by blinded rater based on all available information, score range 1-7, lower is better
10 weeks, change

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression- Severity (CGI-S)
Time Frame: 10 weeks, change
Global rating of symptom severity by blinded rater based on all available information, score range 1-7, lower is better
10 weeks, change
Broset Violence Checklist (BVC)
Time Frame: 10 weeks, change
Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better
10 weeks, change
SNAP-IV
Time Frame: 10 weeks, change
Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better
10 weeks, change
Eyberg Child Behavior Inventory (ECBI)
Time Frame: 10 weeks, change
Measures behavior problems frequency/intensity, score range 36-252, lower is better
10 weeks, change
Relationship Problems Questionnaire (RPQ)
Time Frame: 10 weeks, change
Measures relationship problems, score range 0-30, lower is better
10 weeks, change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Study Chair: Christopher Gillberg, Professor, Gillberg Neuropsychiatry Centre, Gothenburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

July 1, 2025

Study Registration Dates

First Submitted

August 2, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNC SiS PR-ESSENCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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