Obsessive-Compulsive Disorder Clinical Trial
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | March 31, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry) | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Chaim Huijser | Levvel |
Netherlands,
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. — View Citation
Maric M, Werff V. Single-Case Experimental Designs in Clinical Intervention Research. Small Sample Size Solutions. 2020;102-111.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic variables | Such as gender, age of the child, cultural background, family functioning, educational level and life events (parent-report). | Assessed at Timepoint 0 (start baseline) | |
Other | Psychiatric DSM-5 diagnosis of the child | Measured using the Structured Clinical Interview for DSM-5 Childhood Disorders (SCID-5 junior) (parent and child interview, clinician-rated). Clinicians rate the presence or absence of DSM-5 diagnosis. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Other | Parenting burden | Measured using the Stress of Parenting Questionnaire (OBVL, parent-report). Items are rated on a scale from 1 to 4. The total score ranges from 34 to 136, with higher scores indicating greater parental burden. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Other | Psychopathology and adaptive functioning of parents | Measured using the Achenbach System of Empirically Based Assessment - Adult Self Report (ASEBA -ASR, parent-report). Items are rated on a scale from 0 ('not true') to 2 ('very true or often true'). The Total Problem score on the ASR, based on 120 problem items, ranges from 0 to 240. Higher scores indicate more problems related to adult psychopathology. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Other | Child Behavior Checklist (CBCL, parent-report) | The Child Behavior Checklist, part of the Achenbach System of Empirically Based Assessment (ASEBA - CBCL), is a parent reported questionnaire that consists 118 items that seek to assess behavioral and emotional problems in children from 6 to 18 years old. Items are rated on a 3-point scale: 0 = 'not true', 1 = 'somewhat or sometimes true' and 2 = 'very true or often true'. It comprises three scales: (1) Internalizing problems; (2) Externalizing problems; (3) Total problem score. Higher scores indicate more emotional- and behavioral problems reported by the parent. On all scales, T-Score = 60 or more indicates a clinical level of the child's emotional and behavioral problems. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Other | Youth Self-report (YSR) (child-report) | The Youth Self-report, part of the Achenbach System of Empirically Based Assessment (ASEBA - YSR), is a child reported questionnaire that consists 112 items that seek to assess behavioral and emotional problems in children from 11 to 18 years old. Items are rated on a 3-point scale: 0 = 'not true', 1 = 'somewhat or sometimes true' and 2 = 'very true or often true'. Higher scores indicate more emotional- and behavioral problems reported by the child. It comprises three scales: (1) Internalizing problems; (2) Externalizing problems; (3) Total problem score. On all scales, T-Score = 60 or more indicates a clinical level of the child's emotional and behavioral problems. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0) | |
Other | Teacher Report Form Emotional- and behavioral problems of the child (teacher- report) | Measured using the Achenbach System of Empirically Based Assessment - Teacher Report Form (ASEBA - TRF, teacher-report). Items are rated on a 3-point scale: 0 = 'not true', 1 = 'somewhat or sometimes true' and 2 = 'very true or often true'. Higher scores indicate more emotional- and behavioral problems reported by the teacher. It comprises three scales: (1) Internalizing problems; (2) Externalizing problems; (3) Total problem score. Higher scores indicate more emotional- and behavioral problems reported by the parent. On all scales, T-Score = 60 or more indicates a clinical level of the child's emotional and behavioral problems. | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Other | Treatment satisfaction | Measured using a self-developed questionnaire on treatment preferences and satisfaction (11 questions, parent-report). Items are rated on a scale from 1 to 5, with higher scores indicating greater treatment satisfaction. | Timepoint 4 (± 12 weeks after Timepoint 1) | |
Primary | (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). | 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) | |
Primary | (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. | 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) | |
Primary | (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. | 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) | |
Primary | 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. | 6 months - Assessed 3 times a week during 6 months | |
Primary | 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. | 6 months - Assessed 3 times a week during 6 months | |
Secondary | 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. | 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) | |
Secondary | 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. | 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) | |
Secondary | 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. | Assessed at Timepoint 0 (start baseline) | |
Secondary | 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'). | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Secondary | 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'). | Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0) | |
Secondary | 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). | 3 months - Assessed weekly after each treatment session | |
Secondary | 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. | During the intervention of 3 month, assessed before the start of each treatment session | |
Secondary | 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. | During the intervention of 3 month, assessed after each treatment session | |
Secondary | Treatment adherence | Checklist for therapist, with checkboxes indicating adherence to treatment components. | During the intervention of 3 months, rated after each treatment session |
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