Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356090
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-02
Brief Title:
SPACE a Parent-based Treatment for Pediatric OCD
Sponsor:
Chaim Huijser
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Supportive Parenting for Anxious Childhood Emotions SPACE an Innovative Parent-based Treatment for Children With Obsessive-compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 childs 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 parents caregivers 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
Pediatric obsessive-compulsive disorder OCD is a severely impairing disorder where children experience anxiety or distress-provoking intrusive thoughts obsessions andor 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 childs 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 parents caregivers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None