Behavior Problem of Childhood and Adolescence Clinical Trial
Official title:
Randomized Controlled Trial of PR-ESSENCE - an Intervention Model for Young People With Explosive and Challenging Behavior
Verified date | July 2020 |
Source | Göteborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
problemāsolving. 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.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | 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. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | SNAP-IV change | Rating scale of ADHD symptoms (parent-rated). Range 0-54 Points, lower is better. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | FBIM change | Family Burden of Illness Module (measure of family stress - parent-rated). Range 0-24, lower is better. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | ECBI change | Eyberg Child Behavior Inventory (measure of behavior problems, parent-rated). Range 0-216, lower is better. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | RPQ change | Relationship Problems Questionnaire (measure of relation and attachment, parent-rated). Range 0-30 Points, lower is better. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | 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. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment | |
Secondary | Problem solving scale change | Measures number and type of problem situations solved (therapist-rated). Range 0-infinite number, higher is better. | Baseline, post-treatment/control period (3 months), 6 months and 1 year post-treatment |
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