RCT of PR-ESSENCE - a Problem Solving Model for Youth With Challenging Behavior in Special (SiS) Treatment Homes

NCT ID: NCT04505072

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2025-12-31

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.

Conditions

Behavior Problems; Neurodevelopmental Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PR-ESSENCE treatment

PR-ESSENCE treatment 10 weeks

Group Type: EXPERIMENTAL

PR-ESSENCE

Intervention Type: BEHAVIORAL

Manual-based training of mutual problem-solving

Control

Treatment as usual 10 weeks

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: BEHAVIORAL

General support in daily structure and activities that is given to all youth staying at the treatment homes

Interventions

PR-ESSENCE

Manual-based training of mutual problem-solving

Intervention Type: BEHAVIORAL

Treatment as usual

General support in daily structure and activities that is given to all youth staying at the treatment homes

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Gillberg, Professor

Role: STUDY_CHAIR

Gillberg Neuropsychiatry Centre, Gothenburg University

Locations

Gillberg Neuropsychiatry Centre

Gothenburg, V. Gotaland, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Mats Johnson, MD, PhD

Role: CONTACT

mats.johnson@gnc.gu.se

031-3425971

Facility Contacts

Mats Johnson, MD, PhD

Role: primary

mats.johnson@gnc.gu.se

0762109103

Ingrid Vinsa, BSc

Role: backup

ingrid.vinsa@gnc.gu.se

031-3425970

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GNC SiS PR-ESSENCE

Identifier Type: -

Identifier Source: org_study_id