RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
Primary Purpose
Behavior Problems, Neurodevelopmental Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PR-ESSENCE
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Behavior Problems
Eligibility Criteria
Inclusion Criteria:
- Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls).
- Age 12-17 years
- Intellectual function in the normal range according to WISC-test and clinical judgment
- 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
- Medium to high-risk score on the YLS/CMI behavior problem domain 7
- 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
Sites / Locations
- Gillberg Neuropsychiatry CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PR-ESSENCE treatment
Control
Arm Description
PR-ESSENCE treatment 10 weeks
Treatment as usual 10 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Broset Violence Checklist (BVC)
Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better
SNAP-IV
Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better
Eyberg Child Behavior Inventory (ECBI)
Measures behavior problems frequency/intensity, score range 36-252, lower is better
Relationship Problems Questionnaire (RPQ)
Measures relationship problems, score range 0-30, lower is better
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04505072
Brief Title
RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
Official Title
Randomized Controlled Study of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
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.
Detailed Description
PR-ESSENCE is a problem-solving training program developed by our research team, inspired by Dr Greene´s model "Collaborative and Proactive Solutions (CPS)". We recently completed an RCT with PR-ESSENCE at the Gillberg Centre, Gothenburg University, including 108 children and adolescents who had complex neurodevelopmental disorders such as autism, ADHD, ODD, Tourette, learning difficulties etc and challenging behaviors. The study showed significant global improvements in behavior problems with a large effect size.
The PR-ESSENCE model is designed to train and develop mutual problem solving strategies for children and adolescents with neurodevelopmental disorders (ESSENCE, an umbrella term coined by Gillberg 2010 = Early Symptomatic Syndromes Eliciting Neuropsychiatric Clinical Examinations, which puts focus on the considerable overlap several of these syndromes have). Many youth who are placed in youth treatment homes due to challenging and risk-taking behaviors have been shown to have ESSENCE impairments.
The present study is a randomized controlled trial of PR-ESSENCE treatment for youth with challenging behavior in two youth treatment homes in southwestern Sweden, Bjorkbacken (girls) and Nereby (boys). We plan to include 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). Exclusion criteria: Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition which would make study participation unsuitable. Psychoactive medication is allowed if stable at least one month before baseline, and during the trial.
At baseline a medical and neuropsychiatric history is taken by psychologist and physician (a standard assessment done for all youth placed at the homes), including rating of history of risk behaviors with Youth Level of Service/Case Management Inventory (YLS/CMI), and a DSM-5-diagnostic screening (DSM-5-CCSM) for psychiatric symptoms. Intellectual level will be tested with WISC-V. The participants will do self-ratings of psychiatric symptoms and self-concept with Becks Youth Inventories. The therapists interview parents/carers about history of neuropsychiatric symptoms with the A-TAC-interview.
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 also 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 independent 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 made daily by contact persons and teachers during the whole study. During treatment, therapists rate every week with a Problem Rating Scale how many problem situations are completely or partly solved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problems, Neurodevelopmental Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Primary outcome assessed by blinded rater
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PR-ESSENCE treatment
Arm Type
Experimental
Arm Description
PR-ESSENCE treatment 10 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment as usual 10 weeks
Intervention Type
Behavioral
Intervention Name(s)
PR-ESSENCE
Intervention Description
Manual-based training of mutual problem-solving
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
General support in daily structure and activities that is given to all youth staying at the treatment homes
Primary Outcome Measure Information:
Title
Clinical Global Impression- Improvement (CGI-I)
Description
Global rating of improvement by blinded rater based on all available information, score range 1-7, lower is better
Time Frame
10 weeks, change
Secondary Outcome Measure Information:
Title
Clinical Global Impression- Severity (CGI-S)
Description
Global rating of symptom severity by blinded rater based on all available information, score range 1-7, lower is better
Time Frame
10 weeks, change
Title
Broset Violence Checklist (BVC)
Description
Measures problem behaviors frequency/intensity, score range 0-36 per day, lower is better
Time Frame
10 weeks, change
Title
SNAP-IV
Description
Measures ADHD and Oppositional Defiant symptoms, score range ADHD 0-54, ODD 24, lower is better
Time Frame
10 weeks, change
Title
Eyberg Child Behavior Inventory (ECBI)
Description
Measures behavior problems frequency/intensity, score range 36-252, lower is better
Time Frame
10 weeks, change
Title
Relationship Problems Questionnaire (RPQ)
Description
Measures relationship problems, score range 0-30, lower is better
Time Frame
10 weeks, change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Youth with problem behaviors, placed for at least 3 months in the youth treatment homes Nereby (boys) and Bjorkbacken (girls).
Age 12-17 years
Intellectual function in the normal range according to WISC-test and clinical judgment
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
Medium to high-risk score on the YLS/CMI behavior problem domain 7
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mats Johnson, MD, PhD
Phone
031-3425971
Email
mats.johnson@gnc.gu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Gillberg, Professor
Organizational Affiliation
Gillberg Neuropsychiatry Centre, Gothenburg University
Official's Role
Study Chair
Facility Information:
Facility Name
Gillberg Neuropsychiatry Centre
City
Gothenburg
State/Province
V. Gotaland
ZIP/Postal Code
411 19
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mats Johnson, MD, PhD
Phone
0762109103
Email
mats.johnson@gnc.gu.se
First Name & Middle Initial & Last Name & Degree
Ingrid Vinsa, BSc
Phone
031-3425970
Email
ingrid.vinsa@gnc.gu.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes
We'll reach out to this number within 24 hrs