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

NCT06152913 | Completed

• 1 other identifier: PSY-2223-S-0358
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anxiety; OCD; Non-responder; Exposure; Children and adolescents; CBT

Outcome Measures

Primary Outcomes (1)

• Individualized treatment goals

  Measured daily using the Goal Based Outcomes (GBO) questionnaire. Each participant will set 3 individualized anxiety/OCD-related goals for the treatment, scored on a scale from 1 - 10, where higher scores indicate improved goal progress.

  Daily child ratings (13 weeks), Timepoint0 (start baseline), Timepoint1 (pre-treatment), Timepoint2 (post-treatment, 9 weeks later), and Timepoint3 (follow-up, 4 weeks later); parent-rating at Timepoint0, Timepoint1, Timepoint2 and Timepoint3

Secondary Outcomes (11)

• Severity/remission of primary diagnosis

  Child and parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2)

• Anxiety symptoms

  Child and parent ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2)

• OCD severity

  Combined child and parent ratings at Timepoint0 (start baseline), Timepoint1 (pre-treatment, 2.5-4 weeks after start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1), Timepoint3 (follow-up, 4 weeks after Timepoint2)

• Family accommodation

  Parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2)

• School refusal

  Child and parent ratings at Timepoint0 (start baseline), Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment, 2.5-4 weeks after start baseline]), and Timepoint3 (follow-up, 4 weeks after Timepoint2)

Other Outcomes (7)

• Descriptive measures at baseline

  Timepoint0 (start baseline)

• Descriptive measures at baseline

  Timepoint0 (start baseline)

• Descriptive measures at baseline

  Timepoint0 (start baseline)

Study Arms (1)

HANDS-ON treatment with random baselines

EXPERIMENTAL

Participants are randomly allocated to one of four baseline periods (2.5 weeks, 3 weeks, 3.5 weeks, or 4 weeks). Participants then receive the HANDS-ON treatment. This treatment consists of three phases across nine weeks. After the treatment, there is a follow-up period of 4 weeks.

Behavioral: HANDS-ON treatment

Interventions

HANDS-ON treatment BEHAVIORAL

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.

HANDS-ON treatment with random baselines

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 10-18 years old;
• Meeting DSM-5 criteria for an anxiety disorder/OCD, based on a semi-structured interview (SCID-5 Jr; \[12\]) and clinical judgement of an experienced and authorized clinician;
• Non-responder to previous CBT (insufficient benefits from previous CBT for AD/OCD).
• Comorbid diagnoses are allowed except for those interfering with safety or warranting immediate treatment, e.g., acute suicidality or psychosis.

You may not qualify if:

• Severe psychiatric symptoms other than anxiety/OCD interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.

Sponsors & Collaborators

• Accare: lead

Study Sites (1)

Accare

Groningen, Provincie Groningen, 9723 HE, Netherlands

Location

Related Publications (6)

• Law, D., & Jacob, J. (2015). Goals and Goal Based Outcomes (GBOs): Some useful information. Third Edition. London, UK: CAMHS Press

  BACKGROUND

• Wante, Braet, C., Bögels, S., & Roelofs, J. (2021). SCID-5 Junior: Een semi-gestructureerd klinisch interview voor DSM-5 stoornissen bij kinderen en adolescenten. Boom. http://hdl.handle.net/1854/LU-8695564

  BACKGROUND

• Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.

  PMID: 10937431 BACKGROUND

• Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.

  PMID: 9183141 BACKGROUND

• Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.

  PMID: 22965863 BACKGROUND

• Heyne, D. A., Vreeke, L., & Maric, M. (2008). School Refusal Assessment Scale-Revised (kindversie) Nederlandse vertaling en bewerking. Universiteit Leiden. https://effectivechildtherapy.fiu.edu/pluginfile.php/1783/mod_resource/content/2/41_School%20Refusal%20Scale.pdf.pdf

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• L. Wolters, Dr.

  Accare

  PRINCIPAL INVESTIGATOR

• M. H. Nauta, Dr.

  Accare, University of Groningen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Note that research assistants will be blinded for the baseline length of participants during the interview assessments
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple baseline single-case experimental design

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 1, 2023
• Study Start: December 4, 2023
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data can be requested after publication.
• Access Criteria: The pseudonymized merged, prepared and analysed dataset may become available for re-use, in line with the FAIR principles. Since the data is sensitive, data will not be openly and publicly available. However, they could be shared for research purposes such as for (individual patient data) meta-analyses, and questionnaire (validation) studies by established experts in the field. The Principle Investigator is responsible for the data and can be contacted for questions.

Locations

NL (1)