Behavior ProblemsNCT04505072
RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
A study testing PR-ESSENCE and Treatment as usual in people with Behavior Problems and Neurodevelopmental Disorders, run by Göteborg University at 1 site in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Behavior Problems, Neurodevelopmental Disorders
- What is being tested?
- PR-ESSENCE and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 10 Feb 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls).
- Age 12-17 years
- Intellectual function in the normal range according to WISC-test and clinical judgment
- 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
- Medium to high-risk score on the YLS/CMI behavior problem domain 7
- Psychotropic medication is allowed if stable during one month before baseline and during the randomized period of the trial
Who cannot join
- 1. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition that would make study participation unsuitable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Behavior Problems, Neurodevelopmental Disorders
- Being tested
- PR-ESSENCE, Treatment as usual
- Medical subject headings
- Mental Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR-ESSENCEBehavioural
Manual-based training of mutual problem-solving
Treatment as usualBehavioural
General support in daily structure and activities that is given to all youth staying at the treatment homes
| Study group | Role | What they receive |
|---|---|---|
| PR-ESSENCE treatment | Experimental | PR-ESSENCE treatment 10 weeks Receives: Behavioral: PR-ESSENCE |
| Control | Active comparator | Treatment as usual 10 weeks Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression- Improvement (CGI-I)
Global rating of improvement by blinded rater based on all available information, score range 1-7, lower is better
Measured: 10 weeks, change
Secondary outcomes (5)
Clinical Global Impression- Severity (CGI-S)
Global rating of symptom severity by blinded rater based on all available information, score range 1-7, lower is better
Measured: 10 weeks, change
Broset Violence Checklist (BVC)
Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better
Measured: 10 weeks, change
SNAP-IV
Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better
Measured: 10 weeks, change
Eyberg Child Behavior Inventory (ECBI)
Measures behavior problems frequency/intensity, score range 36-252, lower is better
Measured: 10 weeks, change
Relationship Problems Questionnaire (RPQ)
Measures relationship problems, score range 0-30, lower is better
Measured: 10 weeks, change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start10 Feb 2021
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemsStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Gillberg, Professor, Study chair, Gillberg Neuropsychiatry Centre, Gothenburg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505072
- Sponsor's protocol ID
- GNC SiS PR-ESSENCE
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
- ClinicalTrials.gov ID
- NCT04505072
- Acronym / sponsor ID
- GNC SiS PR-ESSENCE
- Conditions
- Behavior Problems, Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| PR-ESSENCE treatment | Experimental | Behavioral: PR-ESSENCEPR-ESSENCE treatment 10 weeks |
| Control | Active comparator | Behavioral: Treatment as usualTreatment as usual 10 weeks |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls).
- Age 12-17 years
- Intellectual function in the normal range according to WISC-test and clinical judgment
- 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
- Medium to high-risk score on the YLS/CMI behavior problem domain 7
Key exclusion criteria (1 listed)
- 1. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition that would make study participation unsuitable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PR-ESSENCEManual-based training of mutual problem-solving | Behavioural | PR-ESSENCE treatment |
| Treatment as usualGeneral support in daily structure and activities that is given to all youth staying at the treatment homes | Behavioural | Control |
Primary outcome
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
5 secondary outcomes
Clinical Global Impression- Severity (CGI-S)
Time frame: 10 weeks, change
Broset Violence Checklist (BVC)
Time frame: 10 weeks, change
SNAP-IV
Time frame: 10 weeks, change
Eyberg Child Behavior Inventory (ECBI)
Time frame: 10 weeks, change
Relationship Problems Questionnaire (RPQ)
Time frame: 10 weeks, change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Gillberg, Professor study chair
Gillberg Neuropsychiatry Centre, Gothenburg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PR-ESSENCE and Treatment as usual in people with Behavior Problems and Neurodevelopmental Disorders, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression- Improvement (CGI-I) (time frame: 10 weeks, change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.