Obsessive-Compulsive DisorderNCT06356090
SPACE: a Parent-based Treatment for Pediatric OCD
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) in people with Obsessive-Compulsive Disorder and Obsessive-Compulsive Disorder in Children, run by Chaim Huijser at 1 site in Netherlands.
Trial summary
This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence
- What is being tested?
- Supportive Parenting for Anxious Childhood Emotions (SPACE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Nov 2023to 31 Mar 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The child ages between 7 - 18 years old
- The child meets the DSM-5 criteria for OCD (as primary classification)
- The child did not benefit from psychological treatment for OCD (either followed 8 to 12 sessions of CBT or other psychotherapy), aborted treatment early or was unable/not motivated to receive treatment due to high levels of anxiety/OCD)
- At time of baseline still meets the clinical cut-off of 16 or higher for OCD on the Child Yale-Brown Obsessive Compulsive Scale [CY-BOCS].
- Psychiatric comorbidity is allowed, provided that OCD is the primary treatment target
- Parents report high levels of Family Accommodation (FA) at time of baseline (meeting the cut-off of 10 or higher on the Family Accommodation Scale Anxiety [FASA])
- Medication use is allowed. Selective serotonin reuptake inhibitors (SSRI) use (for OCD symptoms) is allowed as well, provided that the medication regime has been stable 4 weeks prior to participation and remains unchanged during participation.
Who cannot join
- The child needs inpatient treatment
- Acute suicidality
- Psychotic symptoms
- No participating parents
- Parents have insufficient mastery of the Dutch language
- Parents or child have an estimated IQ below 75
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry)
Amsterdam
J.D.K. Veeger
C. Huijser, Dr.
About this study
Official title: Supportive Parenting for Anxious Childhood Emotions (SPACE): an Innovative Parent-based Treatment for Children With Obsessive-compulsive Disorder
This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment.
Read the detailed description
Background:
Pediatric obsessive-compulsive disorder (OCD) is a severely impairing disorder where children experience anxiety or distress-provoking intrusive thoughts (obsessions) and/or engage in time-consuming ritualistic behaviours (compulsions). Approximately 40% of youth with OCD do not benefit from first-line treatment such as cognitive behavioral therapy (CBT) and pharmacotherapy. Family accommodation (FA) is highly prevalent in families of children affected by OCD. FA encompasses all behaviors of parents, siblings and other caregivers aimed to alleviate distress in the affected child. High levels of FA are associated with greater symptom severity, poorer functioning and inferior treatment outcomes in children and adolescents. However, FA is an under-addressed aspect in the treatment of children and adolescents. SPACE is a parent-based treatment where parents are taught to reduce FA and increase supportive responses towards the child, aiming to improve the child's OCD. An unique advantage of the program is that SPACE can be applied without cooperation of the child.
Objective:
The objectives of the present study are:
- to investigate whether SPACE is effective in reducing FA and OCD symptoms in children with complex OCD
- to explore mechanisms of change (in OCD symptoms) for the effectiveness of the SPACE treatment.
Method:
In this study, the investigators aim to include 25 Dutch children with OCD, their parent(s)/ caregiver(s) and their teacher.
To be eligible to participate in this study, subject must meet the following criteria: a) child (age 7-18 years) meets DSM-5 criteria for OCD (as primary classification) and meets the clinical cut-off score of 16 or higher for OCD on the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) at baseline; b) previous psychosocial treatment for OCD was insufficient, child aborted treatment or was unable/ not motivated to receive treatment due to high level of anxiety/ OCD); c) Parents show high levels of FA at time of baseline on the Family Accommodation Scale Anxiety (FASA).
Medication use is allowed, provided that the medication regime had been stable for 4 weeks prior to participation and remains unchanged during participation.
Psychiatric comorbidity is allowed; however, a subject meeting any of the following criteria will be excluded for participation in this study: a) need for inpatient treatment; b) acute suicidality; c) psychotic symptoms d) no participating parents e) parents have insufficient mastery of the Dutch language f) parent or child has an estimated IQ below 75.
Design:
The current study will use a single-case experimental design (SCED) with multiple baselines. The course of the study will consist of a baseline phase, treatment phase and follow-up phase. Participating parents and their child will be randomized by computer to one of three baseline phase durations (4, 6 or 8 weeks). During the treatment phase, parents follow SPACE, which includes 12 treatment sessions provided by a trained and supervised professional. Throughout the different phases, there will be weekly measurements on FA and OCD symptoms, filled in by parents and children using a smartphone app. Semi-structured interviews will be conducted and questionnaires will be filled out by parents and children at T0 (baseline), T1 (start treatment), T2 (after 4 treatment sessions), T3 (after 8 treatment sessions), T4 (post treatment) and T5 (follow-up) and by teachers at T0, T4 and T5.
Analysis: For primary and secondary study outcomes visual data inspections will be performed to check for changes over time and between different phases of the SCED. A Reliable Change Index (RCI) will be calculated for changes in OCD symptoms and FA between pre- and post treatment assessments. Multilevel modeling will be used to test within-person changes over time. Meta-analysis will be performed over all included participants to test effects on group level. To explore mechanisms of change, cross-lagged correlations will be calculated to explore associations between two variables over time. Descriptive analysis will be used to determine predictors of treatment outcome.
- Conditions
- Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence, Anxiety Disorders and Symptoms
- Being tested
- Supportive Parenting for Anxious Childhood Emotions (SPACE)
- Keywords
- SPACE, Family Accommodation, OCD, Anxiety, Children & adolescents, Parent-only treatment
- Medical subject headings
- Obsessive-Compulsive Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Parenting for Anxious Childhood Emotions (SPACE)Behavioural
SPACE is a parent-based treatment (parent-stand-alone treatment) for parents of youth with anxiety symptoms or OCD. The manualized treatment protocol contains 12 sessions, in which parents are taught to reduce family accommodation (FA) and to increase supportive responses to their child.
| Study group | Role | What they receive |
|---|---|---|
| SPACE treatment with random baselines | Experimental | Participants are randomly allocated to one of three baseline periods (4 weeks, 6 weeks or 8 weeks). Only the parents of the participating families receive the SPACE treatment (12 sessions across 12 weeks). After the SPACE treatment, there is a follow-up period of 6 month after baseline. Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Change in) OCD severity
Measured using the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS, a clinician rated semi-structured interview based on a combined parent and child-report). The CY-BOCS contains a severity scale and a symptom checklist. The symptom checklist assesses the current and past potential obsessive and compulsive experiences (indicated with 'yes' or 'no'). The severity scale consist of 5 items on obsession severity and 5 items on compulsion severity, rated on a Likert scale from 0 to 4. Higher scores represent more severity. The CY-BOCS Total Score is the sum of the obsession severity and compulsion severity items (range 0-40, with higher scores representing greater severity).
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after Timepoint 1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
(Change in) family accommodation (parent report)
Measured using the Family Accommodation Scale Anxiety (FASA, parent version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
(Change in) Family accommodation (child report)
Measured using the Family Accommodation Scale Anxiety - Child Rated (FASA-CR, child version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Daily (change in) OCD symptoms
Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived OCD symptoms and more time spent on OCD symptoms.
Measured: 6 months - Assessed 3 times a week during 6 months
Daily (change in) family accommodation
Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived FA and more time spent on FA.
Measured: 6 months - Assessed 3 times a week during 6 months
Secondary outcomes (9)
Symptoms of child anxiety
Measured using the Screen for Childhood Anxiety Related Emotional Disorder- NL (SCARED-NL, child-report). Items are rated on a scale from 0-2. The total score on the SCARED ranges form 0-138. Higher scores indicate more severe anxiety.
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Symptoms of child depression
Measured using the Children Depression Inventory-2 (CDI-2, child-report). Items are rated on a scale from 0-2. The total score ranges from 0-56. Higher scores indicate more severe depressive symptoms.
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Symptoms of autism
Measured using the Social Responsiveness Scale (SRS-2, parent-report). Items are rated on a scale from 0-3. The total score ranges from 0-195. Higher scores indicate greater autism symptom severity.
Measured: Assessed at Timepoint 0 (start baseline)
Quality of life (parent-report)
Measured using the EuroQol 5D (EQ-5D, adult version), consisting the EQ-5D Index and the EQ Visual Analog Scale (EQ VAS). There a 5 predefined dimensions: Mobility, Self-care, Usual activities, Pain/ Discomfort and Anxiety/ Depression. Items are rated on a 3 level scale. The EQ VAS score is rated on a visual analogue scale ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
Quality of life (child-report)
Measured using the EuroQol 5D-Youth (EQ-5D-Y, child-version), consisting the EQ-5D-Y descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive symptom comprises 5 dimensions: Mobility, Looking after myself, Doing usual activities, Having pain or discomfort and Feeling worried, sad or unhappy. Each dimension can be rated on 3 levels: no problems, some problems and a lot of problems. The EQ VAS records the respondent's self-rated health on a visual analogue scale ranging from 0 ('The best health you van imagine') to100 ('The worst health you can imagine').
Measured: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
Clinical impression of outcome
Measured using the Clinical Global Impression scale (CGI, clinician-report). The CGI comprises two one-item measures evaluating: 1) the severity of psychopathology rated on a scale from 0 (no symptoms) to 7 (extremely severe symptoms) and 2) change from the initiation of treatment on a similar scale from 0 (very much improved since initiation of treatment) to 7 (very much worse since the initiation of treatment).
Measured: 3 months - Assessed weekly after each treatment session
Treatment progress
Treatment progress is measured using the Outcome Rating Scale (ORS, parent-report). The ORS comprises 4 short questions rated on a visual analog scale from 0 to 10. Higher scores indicate greater mental health during treatment.
Measured: During the intervention of 3 month, assessed before the start of each treatment session
Session experience
Person's overall therapy experience is measured using the Session Rating Scale (SRS, parent-report). The SRS comprises 4 short questions on a visual analog scale from 0 to10. Higher scores indicate greater satisfaction with the therapeutic alliance.
Measured: During the intervention of 3 month, assessed after each treatment session
Treatment adherence
Checklist for therapist, with checkboxes indicating adherence to treatment components.
Measured: During the intervention of 3 months, rated after each treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start23 Nov 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies 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
- Single group
- Model description
- Single case experimental design (SCED) with multiple baselines
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaim Huijser
- Sponsor type
- University, hospital or other
- Collaborators
- Levvel
- Responsible party
- Sponsor-investigator, Chaim Huijser, Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Investigators
- C. Huijser, Dr., Principal investigator, Amsterdam UMC / Levvel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356090
- Sponsor's protocol ID
- 2023.0322 - NL84369.018.23
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will not be openly and publically available, since the data is sensitive. Qualified researchers can request access to anonymized individual participant data for research purposes such as meta-analyses, and questionnaire validation studies. An encrypted, merged and prepared dataset can be made available for re-use in line with the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. The Principle Investigator is responsible for the data and can be contacted for requests after completion and publication of the present study. Participant will be asked informed consent for re-use and sharing of the anonymous individual participant data. An agreement will be drawn up, when data sharing is requested.
Publications
Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
PubMed 30851397Maric M, Werff V. Single-Case Experimental Designs in Clinical Intervention Research. Small Sample Size Solutions. 2020;102-111.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Parenting for Anxious Childhood Emotions (SPACE): an Innovative Parent-based Treatment for Children With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06356090
- Acronym / sponsor ID
- 2023.0322 - NL84369.018.23
- Conditions
- Obsessive-Compulsive Disorder, Obsessive-Compulsive Disorder in Children, Obsessive-Compulsive Disorder in Adolescence, Anxiety Disorders and Symptoms
- Keywords
- SPACE, Family Accommodation, OCD, Anxiety, Children & adolescents, Parent-only treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Chaim HuijserUniversity, hospital or other
- Collaborators
- Levvel
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 10 Apr 2024 (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.
This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment.
Detailed description
Background:
Pediatric obsessive-compulsive disorder (OCD) is a severely impairing disorder where children experience anxiety or distress-provoking intrusive thoughts (obsessions) and/or engage in time-consuming ritualistic behaviours (compulsions). Approximately 40% of youth with OCD do not benefit from first-line treatment such as cognitive behavioral therapy (CBT) and pharmacotherapy. Family accommodation (FA) is highly prevalent in families of children affected by OCD. FA encompasses all behaviors of parents, siblings and other caregivers aimed to alleviate distress in the affected child. High levels of FA are associated with greater symptom severity, poorer functioning and inferior treatment outcomes in children and adolescents. However, FA is an under-addressed aspect in the treatment of children and adolescents. SPACE is a parent-based treatment where parents are taught to reduce FA and increase supportive responses towards the child, aiming to improve the child's OCD. An unique advantage of the program is that SPACE can be applied without cooperation of the child.
Objective:
The objectives of the present study are:
- to investigate whether SPACE is effective in reducing FA and OCD symptoms in children with complex OCD
- to explore mechanisms of change (in OCD symptoms) for the effectiveness of the SPACE treatment.
Method:
In this study, the investigators aim to include 25 Dutch children with OCD, their parent(s)/ caregiver(s) and their teacher.
To be eligible to participate in this study, subject must meet the following criteria: a) child (age 7-18 years) meets DSM-5 criteria for OCD (as primary classification) and meets the clinical cut-off score of 16 or higher for OCD on the Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) at baseline; b) previous psychosocial treatment for OCD was insufficient, child aborted treatment or was unable/ not motivated to receive treatment due to high level of anxiety/ OCD); c) Parents show high levels of FA at time of baseline on the Family Accommodation Scale Anxiety (FASA).
Medication use is allowed, provided that the medication regime had been stable for 4 weeks prior to participation and remains unchanged during participation.
Psychiatric comorbidity is allowed; however, a subject meeting any of the following criteria will be excluded for participation in this study: a) need for inpatient treatment; b) acute suicidality; c) psychotic symptoms d) no participating parents e) parents have insufficient mastery of the Dutch language f) parent or child has an estimated IQ below 75.
Design:
The current study will use a single-case experimental design (SCED) with multiple baselines. The course of the study will consist of a baseline phase, treatment phase and follow-up phase. Participating parents and their child will be randomized by computer to one of three baseline phase durations (4, 6 or 8 weeks). During the treatment phase, parents follow SPACE, which includes 12 treatment sessions provided by a trained and supervised professional. Throughout the different phases, there will be weekly measurements on FA and OCD symptoms, filled in by parents and children using a smartphone app. Semi-structured interviews will be conducted and questionnaires will be filled out by parents and children at T0 (baseline), T1 (start treatment), T2 (after 4 treatment sessions), T3 (after 8 treatment sessions), T4 (post treatment) and T5 (follow-up) and by teachers at T0, T4 and T5.
Analysis: For primary and secondary study outcomes visual data inspections will be performed to check for changes over time and between different phases of the SCED. A Reliable Change Index (RCI) will be calculated for changes in OCD symptoms and FA between pre- and post treatment assessments. Multilevel modeling will be used to test within-person changes over time. Meta-analysis will be performed over all included participants to test effects on group level. To explore mechanisms of change, cross-lagged correlations will be calculated to explore associations between two variables over time. Descriptive analysis will be used to determine predictors of treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single case experimental design (SCED) with multiple baselines
| Arm | Type | Receives |
|---|---|---|
| SPACE treatment with random baselines | Experimental | Behavioral: Supportive Parenting for Anxious Childhood Emotions (SPACE)Participants are randomly allocated to one of three baseline periods (4 weeks, 6 weeks or 8 weeks). Only the parents of the participating families receive the SPACE treatment (12 sessions across 12 weeks). After the SPACE treatment, there is a follow-up period of 6 month after baseline. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- The child ages between 7 - 18 years old
- The child meets the DSM-5 criteria for OCD (as primary classification)
- The child did not benefit from psychological treatment for OCD (either followed 8 to 12 sessions of CBT or other psychotherapy), aborted treatment early or was unable/not motivated to receive treatment due to high levels of anxiety/OCD)
- At time of baseline still meets the clinical cut-off of 16 or higher for OCD on the Child Yale-Brown Obsessive Compulsive Scale [CY-BOCS].
- Psychiatric comorbidity is allowed, provided that OCD is the primary treatment target
Key exclusion criteria (6 listed)
- The child needs inpatient treatment
- Acute suicidality
- Psychotic symptoms
- No participating parents
- Parents have insufficient mastery of the Dutch language
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 |
|---|---|---|
| Supportive Parenting for Anxious Childhood Emotions (SPACE)SPACE is a parent-based treatment (parent-stand-alone treatment) for parents of youth with anxiety symptoms or OCD. The manualized treatment protocol contains 12 sessions, in which parents are taught to reduce family accommodation (FA) and to increase supportive responses to their child. | Behavioural | SPACE treatment with random baselines |
Primary outcome
(Change in) OCD severity
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after Timepoint 1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Measured using the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS, a clinician rated semi-structured interview based on a combined parent and child-report). The CY-BOCS contains a severity scale and a symptom checklist. The symptom checklist assesses the current and past potential obsessive and compulsive experiences (indicated with 'yes' or 'no'). The severity scale consist of 5 items on obsession severity and 5 items on compulsion severity, rated on a Likert scale from 0 to 4. Higher scores represent more severity. The CY-BOCS Total Score is the sum of the obsession severity and compulsion severity items (range 0-40, with higher scores representing greater severity).
(Change in) family accommodation (parent report)
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Measured using the Family Accommodation Scale Anxiety (FASA, parent version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.
(Change in) Family accommodation (child report)
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after T1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Measured using the Family Accommodation Scale Anxiety - Child Rated (FASA-CR, child version). Items are rated on a Likert scale from 0 to 4, with higher scores representing more family accommodation.
Daily (change in) OCD symptoms
Time frame: 6 months - Assessed 3 times a week during 6 months
Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived OCD symptoms and more time spent on OCD symptoms.
Daily (change in) family accommodation
Time frame: 6 months - Assessed 3 times a week during 6 months
Measured using two self-developed visual slider scales (rated on a 0-10 scale) in a mobile app (parents and child-report). Higher scores indicate more perceived FA and more time spent on FA.
9 secondary outcomes
Symptoms of child anxiety
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Symptoms of child depression
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint0), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
Symptoms of autism
Time frame: Assessed at Timepoint 0 (start baseline)
Quality of life (parent-report)
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
Quality of life (child-report)
Time frame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
Clinical impression of outcome
Time frame: 3 months - Assessed weekly after each treatment session
Treatment progress
Time frame: During the intervention of 3 month, assessed before the start of each treatment session
Session experience
Time frame: During the intervention of 3 month, assessed after each treatment session
Treatment adherence
Time frame: During the intervention of 3 months, rated after each treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Background: PubMed 30851397Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
- BackgroundMaric M, Werff V. Single-Case Experimental Designs in Clinical Intervention Research. Small Sample Size Solutions. 2020;102-111.
- Individual participant dataSharing planned: Yes. Data will not be openly and publically available, since the data is sensitive. Qualified researchers can request access to anonymized individual participant data for research purposes such as meta-analyses, and questionnaire validation studies. An encrypted, merged and prepared dataset can be made available for re-use in line with the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. The Principle Investigator is responsible for the data and can be contacted for requests after completion and publication of the present study. Participant will be asked informed consent for re-use and sharing of the anonymous individual participant data. An agreement will be drawn up, when data sharing is requested.
Related trials for Obsessive-Compulsive Disorder
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruiting
tDCS and Symptom Provocation in Treatment-Resistant OCD
Obsessive - Compulsive Disorder
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder
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.
C. Huijser, Dr. principal investigator
Amsterdam UMC / Levvel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Parenting for Anxious Childhood Emotions (SPACE) in people with Obsessive-Compulsive Disorder and Obsessive-Compulsive Disorder in Children, run by Chaim Huijser 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J.D.K. Veeger, MSc (+31681027462, j.d.k.veeger@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Change in) OCD severity (time frame: Assessed at Timepoint 0 (start baseline), Timepoint 1 (start treatment: 4, 6 or 8 weeks after Timepoint 0), Timepoint 2 (± 4 weeks after T1), Timepoint 3 (± 8 weeks after Timepoint 1), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)). The study lists 5 primary outcomes in all. 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 NCT06356090, which also lists 2 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 10 Apr 2024.