Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Change in clinician-rated child anxiety severity (PARS) throughout the past week.
研究概览
简要总结
Anxiety disorders in children and adolescents are common and confer significant disability. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms. Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions.
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
详细描述
Anxiety disorders in children and adolescents are common and confer significant disability. Without treatment, anxiety remains chronic and contributes to increased risk for later suicidality, mood, and substance use disorders. Cognitive behavioral therapy (CBT) is the recommended treatment for youth with anxiety, yet many families cannot access CBT due to cost, practicalities of attending in-person treatment sessions, and a shortage of trained providers, especially in rural areas. To combat these barriers, other treatment methods have been developed.
Low intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety and their families, given its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to the youth's home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics). Previous research has shown that family-based, internet-delivered CBT (iCBT) for anxiety and OCD in youth has shown a significant reduction in anxiety symptoms.
Parent-coached exposure therapy (PCET) focuses entirely on teaching parents and youth together how to address anxiety through the completion of in-session parent-coached exposures and assigning parent-coached exposure as homework in between sessions. PCET is designed to treat anxiety more effectively and efficiently, allowing for fewer sessions and greater symptom remission than standard-care CBT.
Although both iCBT and PCET show positive results in treating pediatric anxiety in comparison to standard-care CBT, little is known about the comparative efficacy of iCBT and PCET.
This research is being done to understand the comparative effectiveness of two different types of cognitive-behavioral therapy (CBT) for treating anxiety or OCD in youth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor is blinded.
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The child is between the ages of 7 to 17 years inclusive at enrollment.
- •The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
- •The child is appropriate for anxiety-focused treatment (e.g., anxiety or OCD is the primary or co-primary problem as diagnosed using the DIAMOND-KID).
- •One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
- •The participating parent/guardian lives with their child at least 50% of the time per self-report.
- •Both parent and child can read and understand English.
- •The participant has an IQ above 69, based on the KBIT-2, another valid test or clinician judgement (e.g., a previous assessment conducted, and report shared with study team).
- •Participants must be in the state of Texas for treatment sessions/assessments.
排除标准
- •The child has a diagnosis of a lifetime psychotic disorder and/or conduct disorder.
- •The child has significant, current and active suicidality/homicidality and/or self-injury requiring medical intervention.
- •The child has limited verbal communication abilities (e.g., no independent verbal communication).
- •The child is receiving concurrent psychotherapy with anxiety and/or OCD as the primary focus. They can pause ongoing therapy to enroll.
- •The child has initiated new antidepressant medication within 12-weeks of assessment (4-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- •The child has changed psychotropic medication dosage within 4-weeks of assessment (2-weeks for stimulants/benzodiazepines/antipsychotics) or during therapy.
- •The child requires a higher level of care than can be provided through the study (e.g., significant, current suicidal ideation).
研究组 & 干预措施
Parent Coached Exposure Therapy (PCET)
Parent Coached Exposure Therapy (PCET) consists of 12 weekly individual sessions that are attended by the therapist, child, and parent. Sessions will follow the cognitive behavioral therapy model of childhood anxiety disorders, wherein safety behaviors and avoidance reinforce anxiety, explains the rationale of exposure, and begins developing an exposure hierarchy with the family. Sessions will include psychoeducation, developing an exposure hierarchy, carrying out in-session exposures, and assigning exposures in between sessions.
干预措施: Parent Coached Exposure Therapy (Behavioral)
Family-Based Internet-Based CBT Group (iCBT)
One half of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (7 45-minute supportive therapy sessions). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions.
干预措施: Family Based, Internet-Based Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Change in clinician-rated child anxiety severity (PARS) throughout the past week.
时间窗: baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18)
Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
次要结局
- Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) with Clinical Severity Ratings(baseline (before treatment or week 1), post-treatment (week 14), 1 month follow up (Week 18))
- Clinical Global Impression-Severity(baseline (before treatment or Week 1), during treatment (on average 14 weeks), post-treatment (Week 14), 1 month follow up (Week 18))
研究者
Eric A Storch
Professor
Baylor College of Medicine