Anxiety DisordersNCT06152913
HANDS-ON: a Personalized, Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or OCD
A study testing HANDS-ON treatment in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Accare at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Anxiety Disorders, Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children
- What is being tested?
- HANDS-ON treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Dec 2023to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Severe psychiatric symptoms other than anxiety/OCD interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All Hands on Deck: Youth, Therapists, Parents and School Professionals Joining Forces in a Personalized, Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or Obsessive Compulsive Disorder
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.
Read the 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:
- Quantitative: What are (within-subjects) effects of HANDS-ON on personalized goal attainment, anxiety/OCD severity, and functioning in youth with persistent AD/OCD?
- 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
- Being tested
- HANDS-ON treatment
- Keywords
- Anxiety, OCD, Non-responder, Exposure, Children and adolescents, CBT
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HANDS-ON treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HANDS-ON treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured using the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 Junior) [child and parent report], with severity indicated as Clinical Severity Rating rated from 1 - 8 (adapted from the Anxiety Disorders Interview Schedule for DSM-IV, ADIS-IV) and higher ratings indicating higher severity.
Measured: 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
Measured using the Revised Child Anxiety and Depression Scale (RCADS) [child and parent report], with items rated as 0 ('Never'), 1 ('Sometimes'), 2 ('Often'), and 3 ('Always') and higher scores indicating more severity.
Measured: 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
Only in case of OCD. Measured using the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [combined child and parent report], with items rated from 0 - 4 and higher scores indicating more severity.
Measured: 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
Measured using the Family Accommodation Scale - Anxiety/OCD (FASA, parent version), with items rated from 0 - 4 and higher scores indicating more family accommodation.
Measured: 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
Measured using the School Refusal Assessment Scale-Revised for Children (SRAS-R(-NL)-C/P) [child and parent report], with items ranging from 0 - 6 and higher scores indicating more school refusal.
Measured: 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)
Motivation
Measured using three items with self-developed visual analogue slider scales, with ratings ranging from 0 - 100 and higher scores indicating more motivation.
Measured: Child 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)
Clinical global impression
Measured using the Clinical Global Impression (CGI) Scale (Severity, Improvement) [clinician rated], with two items ranging from 1 - 7 and higher scores indicating more deterioration.
Measured: Clinician 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)
Treatment adherence
Checklist for therapists [clinician rated], with checkboxes indicating adherence (or deviations) to treatment components
Measured: Clinician rating at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline])
Qualitative interview
Treatment evaluation, child, parent, and therapist interviews
Measured: Between Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline]) and Timepoint3 (follow-up, 4 weeks after Timepoint2)
Treatment satisfaction questionnaire
Measured using a self-developed satisfaction scale [child and parent reports], scale title and minimum/maximum values to be specified
Measured: Child and parent ratings at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline])
Daily anxiety or OCD symptoms
Measured daily using two self-developed visual analogue slider scales. One slider measures impairment on a scale from 0 - 100. The other measures avoidance on a scale from 0 - 100. Higher scores indicate more impairment and avoidance.
Measured: Child rating daily through baseline (2.5-4 weeks), treatment (9 weeks) and partially during follow-up (91 days [13 weeks] for each participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start4 Dec 2023
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Multiple baseline single-case experimental design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L. Wolters, Dr., Principal investigator, AccareM. H. Nauta, Dr., Study chair, Accare, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152913
- Sponsor's protocol ID
- PSY-2223-S-0358
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the present study, data can be made available and shared for re-use and participants will be asked informed consent for this (Findable, Accessible, Interoperable, and Reusable \['FAIR'\] data). Requests for data sharing will be assessed by the Principal investigator. When data sharing is requested, an agreement will be drawn up. Consent is asked for using and sharing pseudonymized data for instance for reviews, (individual patient data) meta-analyses, and questionnaire (validation) studies. 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.
Publications
Law, D., & Jacob, J. (2015). Goals and Goal Based Outcomes (GBOs): Some useful information. Third Edition. London, UK: CAMHS Press
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
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.
PubMed 10937431Scahill 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.
PubMed 9183141Lebowitz 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.
PubMed 22965863Heyne, 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All Hands on Deck: Youth, Therapists, Parents and School Professionals Joining Forces in a Personalized, Brief and Intensive Exposure-based Intervention for Youth With Persistent Anxiety or Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT06152913
- Acronym / sponsor ID
- PSY-2223-S-0358
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AccareUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Quantitative: What are (within-subjects) effects of HANDS-ON on personalized goal attainment, anxiety/OCD severity, and functioning in youth with persistent AD/OCD?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline single-case experimental design
| Arm | Type | Receives |
|---|---|---|
| HANDS-ON treatment with random baselines | Experimental | Behavioral: HANDS-ON treatmentParticipants 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe psychiatric symptoms other than anxiety/OCD interfering with safety or warranting immediate intervention, e.g. psychosis or acute suicidality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HANDS-ON treatmentThe 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. | Behavioural | HANDS-ON treatment with random baselines |
Primary outcome
Individualized treatment goals
Time frame: 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
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.
11 secondary outcomes
Severity/remission of primary diagnosis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Motivation
Time frame: Child 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)
Clinical global impression
Time frame: Clinician 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)
Treatment adherence
Time frame: Clinician rating at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline])
Qualitative interview
Time frame: Between Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline]) and Timepoint3 (follow-up, 4 weeks after Timepoint2)
Treatment satisfaction questionnaire
Time frame: Child and parent ratings at Timepoint2 (post-treatment, 9 weeks after Timepoint1 [pre-treatment] and 11.5-13 weeks after Timepoint0 [pre-baseline])
Daily anxiety or OCD symptoms
Time frame: Child rating daily through baseline (2.5-4 weeks), treatment (9 weeks) and partially during follow-up (91 days [13 weeks] for each participant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- BackgroundLaw, D., & Jacob, J. (2015). Goals and Goal Based Outcomes (GBOs): Some useful information. Third Edition. London, UK: CAMHS Press
- BackgroundWante, 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: PubMed 10937431Chorpita 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.
- Background: PubMed 9183141Scahill 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.
- Background: PubMed 22965863Lebowitz 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.
- BackgroundHeyne, 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
- Individual participant dataSharing planned: Yes. After completion of the present study, data can be made available and shared for re-use and participants will be asked informed consent for this (Findable, Accessible, Interoperable, and Reusable ['FAIR'] data). Requests for data sharing will be assessed by the Principal investigator. When data sharing is requested, an agreement will be drawn up. Consent is asked for using and sharing pseudonymized data for instance for reviews, (individual patient data) meta-analyses, and questionnaire (validation) studies. 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.
Related trials for Anxiety Disorders
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain, Anxiety
Recruiting
Impact of Virtual Reality on Anxiety in Patients Undergoing Interventional Procedures
Anxiety
Recruiting
The COMParing App Support Strategies Study
Depression, Anxiety
Active, not recruitingPhase 2
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Anxiety, Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Wolters, Dr. principal investigator
Accare
M. H. Nauta, Dr. study chair
Accare, University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HANDS-ON treatment in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Accare at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individualized treatment goals (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152913, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.