Neurodevelopmental Disorders Clinical Trial
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: 1. Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls). 2. Age 12-17 years 3. Intellectual function in the normal range according to WISC-test and clinical judgment 4. 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 5. Medium to high-risk score on the YLS/CMI behavior problem domain 7 6. Psychotropic medication is allowed if stable during one month before baseline and during the randomized period of the trial Exclusion Criteria: 1. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition that would make study participation unsuitable |
Country | Name | City | State |
---|---|---|---|
Sweden | Gillberg Neuropsychiatry Centre | Gothenburg | V. Gotaland |
Lead Sponsor | Collaborator |
---|---|
Göteborg University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 10 weeks, change | |
Secondary | 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 | 10 weeks, change | |
Secondary | Broset Violence Checklist (BVC) | Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better | 10 weeks, change | |
Secondary | SNAP-IV | Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better | 10 weeks, change | |
Secondary | Eyberg Child Behavior Inventory (ECBI) | Measures behavior problems frequency/intensity, score range 36-252, lower is better | 10 weeks, change | |
Secondary | Relationship Problems Questionnaire (RPQ) | Measures relationship problems, score range 0-30, lower is better | 10 weeks, change |
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