Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUppsala University Hospital

About this trial

The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care.

The main question the study aims to answer is:

What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement?

Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format).

Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient fulfills the diagnostic criteria of obsessive-compulsive disorder

The patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment

Disqualifiers

The patient/legal guardians are unable to communicate in Swedish

Trial design

Design model

Single group

Treatments tested in this trial

  • Concentrated exposure and response prevention

    Behavioral

    The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h)

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Concentrated exposure and response preventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)

The Childrens Yale-Brown Obsessive-Compulsive Scale is a semi-structured interview made up of 10 items rated on a 5-point Likert scale evaluating the severity of Obsessions and Compulsions across five dimensions; Frequency, Interference, Distress, Resistance, and Control, during the previous week and up to the time of interview. The total score varies between 0 and 40. Higher scores indicate higher severity of Obsessions and Compulsions.

Time frame
pre-intervention; one week after the intervention; six months after the intervention

Secondary outcomes

1

Clinical Global Impression (CGI)

The Clinical Global Impression is a brief, stand-alone assessment of the clinicians view of the patients global functioning prior to and after initiating treatment. It comprises two one-item measures evaluating (a) severity of psychopathology from 1 to 7 where a higher score indicates a higher severity, and (b) change from the initiation of treatment from 1 to 7, where a lower score indicates more improvement (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)

Time frame
pre-intervention; one week after the intervention; six months after the intervention
2

Dimensional Obsessive-Compulsive Scale - Child Version (DOCS-CV)

The Dimensional Obsessive-Compulsive Scale - Child Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.

Time frame
pre-intervention; one week after the intervention; six months after the intervention
3

The Obsessive Compulsive Inventory-Child Version (OCI-CV)

A 21-item self-report measure that assesses obsessive compulsive symptoms in children and adolescents aged 7 to 17 years over the preceding one month. It is a Likert-type rating scale, scored 0 to 2 (where 0 = never, 1 = sometimes and 2 = always). The total score varies between 0 and 42 where higher scores indicate more symptoms.

Time frame
pre-intervention; one week after the intervention; six months after the intervention
4

Dimensional Obsessive-Compulsive Scale - Parent Version (DOCS-PV)

The Dimensional Obsessive-Compulsive Scale - Parent Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for parents or legal guardians to children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.

Time frame
pre-intervention; one week after the intervention; six months after the intervention

Other outcomes

Sponsors and contacts

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Uppsala University Hospital

Lead sponsor

Uppsala University

Collaborator