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HANDS-ON: a Personalized, Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or OCD

NCT06152913 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-08

No results posted yet for this study

Summary

A substantial part of children/adolescents with anxiety or obsessive-compulsive disorder (AD/OCD) do not profit substantially from first-choice treatment (i.e., cognitive behavioral therapy; CBT). For them, no evidence-based treatment is available. The aim of this project is to evaluate and optimize a newly-developed personalized, short, and intensive exposure-based intervention, 'HANDS-ON', for 'treatment non-responders'. Collaboration with children, parents and teachers, guided exposure in a child's natural environment, personalized treatment goals and meaning/motivation are central principles.

Methods: A multiple baseline single-case experimental design is used (qualitative and quantitative). Participants are children/adolescents (10-18 years; N=12) with an AD/OCD diagnosis for whom standard CBT did not lead to sufficient improvement. Children and parents are asked to complete questionnaires before, during, and after the treatment. Children, parents, and school professionals will be asked to participate in qualitative interviews to evaluate their experiences with the HANDS-ON treatment program.

Conditions

  • Anxiety Disorders
  • Obsessive-Compulsive Disorder
  • Obsessive-Compulsive Disorder in Children
  • Obsessive-Compulsive Disorder in Adolescence

Interventions

BEHAVIORAL

HANDS-ON treatment

The HANDS-ON treatment consists of three phases: Phase I (preparatory phase, 3 weeks) entails motivation for and commitment to treatment (including meaning in life), collaboration with parents and school professionals, setting individual treatment goals, preparing related exposure exercises. Phase II (intensive phase, 4 weeks) contains intensive, therapist-assisted exposure in a child's natural environment. Phase III (consolidation, 2 weeks) consists of continuation of exposure and consolidation. In this phase, there are weekly sessions with the therapist.

Sponsors & Collaborators

  • Accare

    lead OTHER

Principal Investigators

  • L. Wolters, Dr. · Accare

  • M. H. Nauta, Dr. · Accare, University of Groningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-11-12
Completion
2025-11-12

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06152913 on ClinicalTrials.gov