NCT04505072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 6, 2026

Status Verified

August 1, 2025

Enrollment Period

4.4 years

First QC Date

August 2, 2020

Last Update Submit

March 5, 2026

Conditions

Behavior ProblemsNeurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Clinical Global Impression- Severity (CGI-S)

    10 weeks, change

  • Broset Violence Checklist (BVC)

    10 weeks, change

  • SNAP-IV

    10 weeks, change

  • Eyberg Child Behavior Inventory (ECBI)

    10 weeks, change

  • Relationship Problems Questionnaire (RPQ)

    10 weeks, change

Study Arms (2)

PR-ESSENCE treatment

EXPERIMENTAL

PR-ESSENCE treatment 10 weeks

Behavioral: PR-ESSENCE

Control

ACTIVE COMPARATOR

Treatment as usual 10 weeks

Behavioral: Treatment as usual

Interventions

PR-ESSENCEBEHAVIORAL

Manual-based training of mutual problem-solving

PR-ESSENCE treatment
Treatment as usualBEHAVIORAL

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

Control

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \. Intellectual disability, bipolar syndrome, psychosis, substance use, or other unstable psychiatric or medical condition that would make study participation unsuitable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gillberg Neuropsychiatry Centre

Gothenburg, V. Gotaland, 411 19, Sweden

Location

MeSH Terms

Conditions

Mental DisordersNeurodevelopmental Disorders

Interventions

Therapeutics

Study Officials

  • Christopher Gillberg, Professor

    Gillberg Neuropsychiatry Centre, Gothenburg University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Primary outcome assessed by blinded rater
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2020

First Posted

August 7, 2020

Study Start

February 10, 2021

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

March 6, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)