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PR-ESSENCE for Youth With Challenging Behavior

Primary Purpose

Behavior Problem of Childhood and Adolescence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PR-ESSENCE treatment
Control (TAU)
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Problem of Childhood and Adolescence

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Children and adolescents aged 5 to18 years with neuropsychiatric diagnoses and serious challenging behaviors/explosive reactions.
  2. Intellectual function in the normal range, according to WISC-test, adaptive function and clinical judgment.
  3. 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.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    PR-ESSENCE treatment

    Control (TAU)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    SNAP-IV change
    Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.
    FBIM change
    Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.
    ECBI change
    Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.
    RPQ change
    Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.
    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.
    Problem solving scale change
    Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.

    Full Information

    First Posted
    December 13, 2018
    Last Updated
    July 29, 2020
    Sponsor
    Göteborg University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03780413
    Brief Title
    PR-ESSENCE for Youth With Challenging Behavior
    Official Title
    Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Göteborg University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behavior Problem of Childhood and Adolescence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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
    Outcomes Assessor
    Masking Description
    Blinded assessors
    Allocation
    Randomized
    Enrollment
    108 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PR-ESSENCE treatment
    Arm Type
    Active Comparator
    Arm Description
    The treatment group receives PR-ESSENCE for 10 weeks. Outcome measures are collected pre- and post-treatment, and after 6 months and one year.
    Arm Title
    Control (TAU)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    PR-ESSENCE treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control (TAU)
    Primary Outcome Measure Information:
    Title
    CGI-S/CGI-I change
    Description
    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.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Secondary Outcome Measure Information:
    Title
    ODD Scale change
    Description
    Oppositional Defiant Rating Scale (Ross Greene's), parent-rated. An assessment of DSM-5 Oppositional Defiant Disorder symptoms. Range 34-170, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    SNAP-IV change
    Description
    Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    FBIM change
    Description
    Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    ECBI change
    Description
    Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    RPQ change
    Description
    Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    Beck's Youth Inventory change
    Description
    Self-rating of depression, anxiety, irritability, behavior problems, and self-image. Self-rated by interview. Range 0-300, lower is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment
    Title
    Problem solving scale change
    Description
    Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better.
    Time Frame
    Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Bipolar disorder, psychosis, or other unstable psychiatric or medical condition that according to the investigators opinion makes study participation unsuitable. Substance Use.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher Gillberg, Professor
    Organizational Affiliation
    Gillberg Neuropsychiatry Centre, Goteborg University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34218336
    Citation
    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.
    Results Reference
    derived

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