Clinical trial NCT06356090: SPACE: a Parent-based Treatment for Pediatric OCD
Official title: Supportive Parenting for Anxious Childhood Emotions (SPACE): an Innovative Parent-based Treatment for Children With Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Levvel
First posted: 2024-04-10
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single case experimental design (SCED) with multiple baselines
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: (Change in) OCD severity
timeFrame: 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)
measure: (Change in) family accommodation (parent report)
timeFrame: 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)
measure: (Change in) Family accommodation (child report)
timeFrame: 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)
measure: Daily (change in) OCD symptoms
timeFrame: 6 months - Assessed 3 times a week during 6 months
measure: Daily (change in) family accommodation
timeFrame: 6 months - Assessed 3 times a week during 6 months
Secondary outcomes:
measure: Symptoms of child anxiety
timeFrame: 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)
measure: Symptoms of child depression
timeFrame: 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)
measure: Symptoms of autism
timeFrame: Assessed at Timepoint 0 (start baseline)
measure: Quality of life (parent-report)
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Quality of life (child-report)
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Clinical impression of outcome
timeFrame: 3 months - Assessed weekly after each treatment session
measure: Treatment progress
timeFrame: During the intervention of 3 month, assessed before the start of each treatment session
measure: Session experience
timeFrame: During the intervention of 3 month, assessed after each treatment session
measure: Treatment adherence
timeFrame: During the intervention of 3 months, rated after each treatment session
Other outcomes:
measure: Demographic variables
timeFrame: Assessed at Timepoint 0 (start baseline)
measure: Psychiatric DSM-5 diagnosis of the child
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Parenting burden
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Psychopathology and adaptive functioning of parents
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Child Behavior Checklist (CBCL, parent-report)
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Youth Self-report (YSR) (child-report)
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after T1) & Timepoint 5 (6 months after T0)
measure: Teacher Report Form Emotional- and behavioral problems of the child (teacher- report)
timeFrame: Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0)
measure: Treatment satisfaction
timeFrame: Timepoint 4 (± 12 weeks after Timepoint 1)
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry)
Study officials:
affiliation: Amsterdam UMC / Levvel
name: C. Huijser, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Maric M, Werff V. Single-Case Experimental Designs in Clinical Intervention Research. Small Sample Size Solutions. 2020;102-111.