PR-ESSENCE for Youth With Challenging Behavior
Condition: Behavior Problem of Childhood and Adolescence
MeSH terms: Problem Behavior
Study type: Interventional

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

        1. 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).

        2. Can the PR-ESSENCE model contribute to solve specific problem situations. Outcome
           measure is a Problem Rating Scale developed for this study

        3. 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

        1. Children and adolescents aged 5-18 years with neurodevelopmental disorders and serious
           problematic behaviors.

        2. Intellectual function in the normal range, according to WISC-test and clinical judgment

        3. 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

        1. Bipolar disorder, psychosis, or other unstable psychiatric or medical disorder which in
           the investigator's judgment makes participation in the trial unsuitable.

        2. 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)
    

Intervention name(s): PR-ESSENCE treatment; Control (TAU)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment