Supportive Parenting for Anxious Childhood Emotions (SPACE): an Innovative Parent-based Treatment for Children With Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- (Change in) Family accommodation (child report)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
(Change in) Family accommodation (child report)
时间窗: 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.
(Change in) family accommodation (parent report)
时间窗: 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.
Daily (change in) OCD symptoms
时间窗: 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.
(Change in) OCD severity
时间窗: 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).
Daily (change in) family accommodation
时间窗: 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.
次要结局
- Treatment adherence(During the intervention of 3 months, rated after each treatment session)
- Symptoms of child depression(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(Assessed at Timepoint 0 (start baseline))
- Quality of life (parent-report)(Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0))
- Clinical impression of outcome(3 months - Assessed weekly after each treatment session)
- Session experience(During the intervention of 3 month, assessed after each treatment session)
- Symptoms of child 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))
- Quality of life (child-report)(Assessed at Timepoint 0 (start baseline), Timepoint 4 (± 12 weeks after Timepoint 1) & Timepoint 5 (6 months after Timepoint 0))
- Treatment progress(During the intervention of 3 month, assessed before the start of each treatment session)
研究者
Chaim Huijser
Principal Investigator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)