Behavior Problem of Childhood and AdolescenceNCT03780413
PR-ESSENCE for Youth With Challenging Behavior
A study testing PR-ESSENCE treatment in people with Behavior Problem of Childhood and Adolescence, run by Göteborg University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Behavior Problem of Childhood and Adolescence
- What is being tested?
- PR-ESSENCE treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Dec 2019
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that according to the investigators opinion makes study participation unsuitable.
- Substance Use.
About this study
Official title: Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
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.
Read more
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.
Read the detailed description
The "Collaborative Problem Solving" model was developed by Greene for the treatment of youth with oppositional behavior, and is now called Collaborative \& Proactive Solutions (CPS). The aim of CPS is to help caregivers and children practice and learn problem solving strategies in collaboration. The theoretical base of the model is that problematic behavior is mainly caused by lagging skills, especially regarding frustration tolerance, flexibility and problem solving ability. The CPS model engages both the child and the parents in training, and may therefore have potential to give long-term improvement of lagging skills in handling problematic situations and to change the mindset towards strategies of mutual problem solving.
The CPS model was evaluated in a United States trial comparing CPS to Barkley's Parent Management Training program (PMT) in 47 children aged 4-12 years with ODD and affective dysregulation. Outcomes were similar between the two methods in most measures post-treatment and at 4 months follow-up. A recent larger randomized controlled US trial enrolled 134 children with ODD, aged 7 - 14 years, who were randomized to three groups (CPS, PMT or Waitlist Control). Both treatment groups had equivalent results in treatment response and remission of diagnostic status (50% were much to very much improved and no longer met diagnostic criteria), and both were superior to the WLC condition.
The first Swedish study of CPS, published by our research team 2012, was a small open pilot trial of 3 months CPS for 17 families and children aged 7-13 years, with ADHD, ODD and explosive behavior, showed promising results. At post-treatment 53% of the children were much or very much improved on global symptom and function ratings (Clinical Global Impression-Improvement; CGI-I rating 1-2), and after another 6 months when the children with severe residual ADHD symptoms also had received stimulant medication, 81% reached CGI-I levels of 1-2.
Thus previous research has suggested that CPS is an effective treatment for ODD in youth, but effectiveness in samples of children with various neurodevelopmental disorders has not yet been documented. Oppositional and explosive behavior is a major problem among youth with neurodevelopmental disorders and the demand for treatment strategies is great.
Experiences from treatment of children with complex neurodevelopmental disorders - ESSENCE (mainly including autism) have led the therapists in our team to make ESSENCE-adapted modifications to the CPS model, particularly regarding communication, structure, predictability, and focusing on the child's interests to facilitate interaction. We therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE). During the early phases of this study, Dr. Greene gave advice and supervision to our treatment team, and the whole PR-ESSENCE model would not have been developed without this input.
Research questions
- Can the PR-ESSENCE model reduce problematic behaviors? Outcome measures are the rating scales Swanson, Nolan and Pelham scale (SNAP-IV), Family Burden of Illness Module (FBIM), Eyberg Child Behavior Inventory (ECBI), Clinical Global Impression-Severity scale (CGI-S), Clinical Global Impression-Improvement scale (CGI-I) (see below).
- Can the PR-ESSENCE model contribute to solve specific problem situations. Outcome measure is a Problem Rating Scale developed for this study
- Can the PR-ESSENCE model improve psychiatric well-being and self-image in the participants? Outcome measure is the Beck Youth Inventories.
Method The present study is designed to investigate how well PR-ESSENCE works for challenging behaviors in well-defined clinical samples of children with complex neurodevelopmental disorders. Participants are children and adolescents aged 5-18 years, with any neurodevelopmental diagnosis, and with intellectual level in the normal range.
After neuropsychiatric assessment and diagnosis at our centre or at the Child Psychiatry Centres in Gothenburg 130 children and adolescents aged 5-18 years with complex neurodevelopmental disorders (i.e. autism, ADHD, learning disorders, dyslexia, tics, and Conduct Disorder) and problematic behaviors are invited to participate in the trial. They are randomized to a PR-ESSENCE treatment group and a control group. The treatment group receives PR-ESSENCE for 10 weeks. 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 are collected pre- and post-treatment, and after 6 months and one year. During the PR-ESSENCE treatment period the parents and children meet the therapists at approximately 10 visits, at which they collaborate to find problem solving strategies, which they then practice at home between visits.
Inclusion criteria
- Children and adolescents aged 5-18 years with neurodevelopmental disorders and serious problematic behaviors.
- Intellectual function in the normal range, according to WISC-test and clinical judgment
- Participants taking psychoactive medication can be included if the medication has been unchanged for at least one month before baseline, and remains unchanged during the treatment period.
Exclusion criteria
- Bipolar disorder, psychosis, or other unstable psychiatric or medical disorder which in the investigator's judgment makes participation in the trial unsuitable.
- Substance use.
Outcome measures The following measures are collected at baseline (pre-treatment), after the treatment/TAU period (post-treatment), after 6 months (6-month follow-up) and 1 year (one-year follow-up). To obtain results from different perspectives ratings from four sources were used, i.e. ratings by independent blinded assessors, and by parents, children and therapists.
Rating of independent blinded assessor CGI-I: Scale for global rating of improvement or deterioration of problems/symptoms (scale from 1-7; 1 very much improved, 7 very much worse) CGI-S: Scale for global rating of problem/symptom severity (scale from 1-7; 1 no problems, 7 very severe problems)
Parent ratings SNAP-IV - rating scale for ADHD symptoms FBIM - rating scale of family stress/burden ECBI - rating of behavior problems
Child self-rating Beck Youth Inventories: For rating of depression, anxiety, irritability, externalizing behavior, and self image (child interviewed).
Therapist ratings Problem Rating Scale (in which the severity of the problematic situations before and after treatment is rated)
- Being tested
- PR-ESSENCE treatment, Control (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PR-ESSENCE treatmentBehavioural
Control (TAU)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Secondary outcomes (7)
ODD Scale change
Oppositional Defiant Rating Scale (Ross Greene's), parent-rated. An assessment of DSM-5 Oppositional Defiant Disorder symptoms. Range 34-170, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
SNAP-IV change
Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
FBIM change
Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
ECBI change
Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
RPQ change
Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Beck's Youth Inventory change
Self-rating of depression, anxiety, irritability, behavior problems, and self-image. Self-rated by interview. Range 0-300, lower is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Problem solving scale change
Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.
Measured: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Mar 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior Problem of Childhood and AdolescenceStudies of the same condition, open and under way.
- 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
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Johnson, Göteborg University
- Investigators
- Christopher Gillberg, Professor, Study chair, Gillberg Neuropsychiatry Centre, Goteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780413
- Sponsor's protocol ID
- GNC PR-ESSENCE
- Status last verified
- Jul 2020
- First submitted
- 13 Dec 2018
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34218336
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
- ClinicalTrials.gov ID
- NCT03780413
- Acronym / sponsor ID
- GNC PR-ESSENCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (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.
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.
Detailed description
The "Collaborative Problem Solving" model was developed by Greene for the treatment of youth with oppositional behavior, and is now called Collaborative \& Proactive Solutions (CPS). The aim of CPS is to help caregivers and children practice and learn problem solving strategies in collaboration. The theoretical base of the model is that problematic behavior is mainly caused by lagging skills, especially regarding frustration tolerance, flexibility and problem solving ability. The CPS model engages both the child and the parents in training, and may therefore have potential to give long-term improvement of lagging skills in handling problematic situations and to change the mindset towards strategies of mutual problem solving.
The CPS model was evaluated in a United States trial comparing CPS to Barkley's Parent Management Training program (PMT) in 47 children aged 4-12 years with ODD and affective dysregulation. Outcomes were similar between the two methods in most measures post-treatment and at 4 months follow-up. A recent larger randomized controlled US trial enrolled 134 children with ODD, aged 7 - 14 years, who were randomized to three groups (CPS, PMT or Waitlist Control). Both treatment groups had equivalent results in treatment response and remission of diagnostic status (50% were much to very much improved and no longer met diagnostic criteria), and both were superior to the WLC condition.
The first Swedish study of CPS, published by our research team 2012, was a small open pilot trial of 3 months CPS for 17 families and children aged 7-13 years, with ADHD, ODD and explosive behavior, showed promising results. At post-treatment 53% of the children were much or very much improved on global symptom and function ratings (Clinical Global Impression-Improvement; CGI-I rating 1-2), and after another 6 months when the children with severe residual ADHD symptoms also had received stimulant medication, 81% reached CGI-I levels of 1-2.
Thus previous research has suggested that CPS is an effective treatment for ODD in youth, but effectiveness in samples of children with various neurodevelopmental disorders has not yet been documented. Oppositional and explosive behavior is a major problem among youth with neurodevelopmental disorders and the demand for treatment strategies is great.
Experiences from treatment of children with complex neurodevelopmental disorders - ESSENCE (mainly including autism) have led the therapists in our team to make ESSENCE-adapted modifications to the CPS model, particularly regarding communication, structure, predictability, and focusing on the child's interests to facilitate interaction. We therefore designed a new model, based on our CPS-experience, that we now refer to as PR-ESSENCE (Problem Resolution in ESSENCE). During the early phases of this study, Dr. Greene gave advice and supervision to our treatment team, and the whole PR-ESSENCE model would not have been developed without this input.
Research questions
- Can the PR-ESSENCE model reduce problematic behaviors? Outcome measures are the rating scales Swanson, Nolan and Pelham scale (SNAP-IV), Family Burden of Illness Module (FBIM), Eyberg Child Behavior Inventory (ECBI), Clinical Global Impression-Severity scale (CGI-S), Clinical Global Impression-Improvement scale (CGI-I) (see below).
- Can the PR-ESSENCE model contribute to solve specific problem situations. Outcome measure is a Problem Rating Scale developed for this study
- Can the PR-ESSENCE model improve psychiatric well-being and self-image in the participants? Outcome measure is the Beck Youth Inventories.
Method The present study is designed to investigate how well PR-ESSENCE works for challenging behaviors in well-defined clinical samples of children with complex neurodevelopmental disorders. Participants are children and adolescents aged 5-18 years, with any neurodevelopmental diagnosis, and with intellectual level in the normal range.
After neuropsychiatric assessment and diagnosis at our centre or at the Child Psychiatry Centres in Gothenburg 130 children and adolescents aged 5-18 years with complex neurodevelopmental disorders (i.e. autism, ADHD, learning disorders, dyslexia, tics, and Conduct Disorder) and problematic behaviors are invited to participate in the trial. They are randomized to a PR-ESSENCE treatment group and a control group. The treatment group receives PR-ESSENCE for 10 weeks. 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 are collected pre- and post-treatment, and after 6 months and one year. During the PR-ESSENCE treatment period the parents and children meet the therapists at approximately 10 visits, at which they collaborate to find problem solving strategies, which they then practice at home between visits.
Inclusion criteria
- Children and adolescents aged 5-18 years with neurodevelopmental disorders and serious problematic behaviors.
- Intellectual function in the normal range, according to WISC-test and clinical judgment
- Participants taking psychoactive medication can be included if the medication has been unchanged for at least one month before baseline, and remains unchanged during the treatment period.
Exclusion criteria
- Bipolar disorder, psychosis, or other unstable psychiatric or medical disorder which in the investigator's judgment makes participation in the trial unsuitable.
- Substance use.
Outcome measures The following measures are collected at baseline (pre-treatment), after the treatment/TAU period (post-treatment), after 6 months (6-month follow-up) and 1 year (one-year follow-up). To obtain results from different perspectives ratings from four sources were used, i.e. ratings by independent blinded assessors, and by parents, children and therapists.
Rating of independent blinded assessor CGI-I: Scale for global rating of improvement or deterioration of problems/symptoms (scale from 1-7; 1 very much improved, 7 very much worse) CGI-S: Scale for global rating of problem/symptom severity (scale from 1-7; 1 no problems, 7 very severe problems)
Parent ratings SNAP-IV - rating scale for ADHD symptoms FBIM - rating scale of family stress/burden ECBI - rating of behavior problems
Child self-rating Beck Youth Inventories: For rating of depression, anxiety, irritability, externalizing behavior, and self image (child interviewed).
Therapist ratings Problem Rating Scale (in which the severity of the problematic situations before and after treatment is rated)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| PR-ESSENCE treatment | Active comparator | Behavioral: PR-ESSENCE treatmentThe treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year. |
| Control (TAU) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that according to the investigators opinion makes study participation unsuitable.
- Substance Use.
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-ESSENCE treatment | Behavioural | PR-ESSENCE treatment |
| Control (TAU) | Behavioural | Control (TAU) |
Primary outcome
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.
7 secondary outcomes
ODD Scale change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
SNAP-IV change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
FBIM change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
ECBI change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
RPQ change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Beck's Youth Inventory change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
Problem solving scale change
Time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
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 31 Jul 2020.
- Derived from this study: PubMed 34218336Johnson 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.
- 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, Goteborg University
Questions about this trial
What is this clinical trial studying?
A study testing PR-ESSENCE treatment in people with Behavior Problem of Childhood and Adolescence, run by Göteborg University.
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 3 inclusion and 2 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
CGI-S/CGI-I change (time frame: Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780413, which also lists 1 linked publication.
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 31 Jul 2020.