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

NCT ID: NCT06152913

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-11-12

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.

Detailed Description

BACKGROUND Nearly half of children and adolescents with anxiety or obsessive-compulsive disorders do not reach remission after first-choice treatment (cognitive behavioral therapy; CBT) and 10-25% discontinue treatment prematurely. For them, no evidence-based treatment is available. They may have severe symptoms with a huge impact on daily functioning, quality of life, family life, and society. These youth are at risk of developmental delays, among others due to school refusal. They often receive time-consuming, expensive treatment without evidence of effectiveness.

OBJECTIVES The aim of this project is to evaluate and optimize a newly-developed treatment for this group. This treatment, 'HANDS-ON', is innovative, short and intensive, based on scientific research and insights from clinical practice. Collaboration with children, parents and teachers, guided exposure in a child's natural environment, personalized treatment goals and meaning/motivation are central principles.

Our research questions are:

1. Quantitative: What are (within-subjects) effects of HANDS-ON on personalized goal attainment, anxiety/OCD severity, and functioning in youth with persistent AD/OCD?

2. Qualitative: What are the experiences, facilitators and barriers of HANDS-ON from a child, parent, school professional and therapist perspective?

The results of this study will be used to improve HANDS-ON, with the aim to further investigate its effectiveness in a randomised controlled trial as a next step.

METHOD Participants are 12 children/adolescents with persistent anxiety- or obsessive-compulsive symptoms (treatment non-responders). Inclusion criteria: a) age 10-18 years; b) diagnosis of anxiety disorder or obsessive-compulsive disorder (DSM-5); c) non-response to previous CBT (CBT with insufficient effect). Co-morbid diagnoses are allowed except for those interfering with safety or warranting immediate treatment (e.g., acute suicidality or psychosis).

Design: multiple baseline single-case experimental design. Participants will be randomised to one of four baseline periods (2.5-4 weeks), followed by HANDS-ON (9 weeks) and follow-up (4 weeks). Progress on personalized treatment goals (primary outcome) and on symptoms (impairment and avoidance, secondary outcome) will be measured daily. Other outcomes will be measured at baseline (T0), start HANDS-ON (T1, subset), after HANDS-ON (T2), and at follow-up (T3). Semi-structured interviews (qualitative evaluation) will be conducted with the youth, their parents, school professionals, and therapists (post-treatment).

Analyses: The primary outcome will be analysed using randomisation tests and combined using meta-analytic analyses. Descriptive analyses and tests for repeated measures will be used to analyse secondary outcomes. Qualitative interviews will be recorded and analysed using thematic text analysis.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HANDS-ON treatment with random baselines

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.

Group Type: EXPERIMENTAL

HANDS-ON treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

L. Wolters, Dr.

Role: PRINCIPAL_INVESTIGATOR

Accare

M. H. Nauta, Dr.

Role: STUDY_CHAIR

Accare, University of Groningen

Locations

Accare

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

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

Reference Type: 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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 10937431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9183141 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22965863 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

PSY-2223-S-0358

Identifier Type: -

Identifier Source: org_study_id