Guanfacine Extended Release and Mindfulness in Traumatically Stressed Children and Adolescents Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Changes in ADHD RS-IV
研究概览
简要总结
Teenagers are invited to take part voluntarily in a research study of a study drug known as guanfacine extended release (Intuniv™) and a type of psychotherapy called Mindfulness Skills Training which teaches people how to focus on the present moment in a nonjudgmental manner to help them cope with their stresses and worries. Teenagers are being asked to take part in this study if they have had traumatic stress related over arousal symptoms. He/she may also have difficulties with worries, anxiety, temper, aggression, quick mood changes, behavior problems, and/or difficulties with symptoms of Attention Deficit Hyperactivity Disorder (ADHD) including inattention, hyperactivity, and impulsivity with or without Posttraumatic Stress Disorder (PTSD); and is not responding adequately to his/her current treatment.
The primary purpose of the teenager's participation in this study is to help answer the following research question(s), and not to provide treatment for his or her condition:
- To investigate if Intuniv™ helps for the symptoms of traumatic stress and emotional and behavioral overarousal in children with a history of traumatic developmental stress with and without PTSD.
- To investigate if Intuniv™ helps your teenager engage with and benefit from Mindfulness Skills Training therapy
- To better understand how Intuniv™ works in the brain.
- To investigate how well your child tolerates Intuniv™ during the study.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A lifetime history of traumatic stress documented by self and/or caregiver response on the youth self-report and or caregiver-report Structured Trauma-Related Experiences & Symptoms Screener (STRESS) (i.e., at least one yes response on STRESS items 1-25). AND
- •A baseline STRESS total score ≥ 21 for females or a baseline STRESS total score ≥ 17 for males (STRESS items # 26-48: range of total scores: 0-69) 68 as completed by caregiver OR youth.
- •A lifetime history of traumatic stress documented by self and/or caregiver response on the youth self-report and or caregiver-report Structured Trauma-Related Experiences & Symptoms Screener (STRESS) (i.e., at least one yes response on STRESS items 1-25). AND
- •Clinically significant aggressive behavior during the preceding week assessed by a caregiver-completed Retrospective Modified Overt Aggression (R-MOAS ≥ 24).73 AND
- •A baseline Clinical Global Impressions-Severity Score ≥ 4.74
- •Assent of child and consent of both parents/caregivers.
- •Living with a caregiver legally empowered to permit study enrollment and able to complete protocol assessments.
- •English speaking
- •The child is not responding to or is not tolerating well their current treatment as reported by the parent or child.
- •If female and reports that she is sexually active: Is willing to take a pregnancy test before study participation AND is willing to take an additional pregnancy test during the study as appropriate and necessary, and as determined by the Medical Director of the study.
- •Child and parent willing to give permission for the study team to contact the child's primary care physician, mental health clinician and /or mental health prescriber to communicate any changes in child's symptom status or medications as a result of participation in this research.
- •Exclusion Criteria
- •:• A history of cardiovascular disease, previous history of ECG abnormalities, syncope, exercise-induced cardiovascular symptoms, or any other unstable medical illness/allergy (i.e., seizure disorder) that in the opinion of the site Medical Director precludes enrollment in the study. A clinically significant history of Raynaud's disease is exclusionary.
- •Autistic disorder, persons with intellectual disability (IQ ≤ 70), clinically significant (in the judgment of the site Medical Director) substance abuse disorder (within the past 30 days), bipolar I disorder, schizophrenia or other psychotic disorder, or major depressive disorder with symptoms that are severe enough (e.g. suicidality) that in the opinion of the site Medical Director excludes study participation.
- •Concomitant Medications: Use of other psychiatric medications including extended release guanfacine (study drug) besides a stable dose of stimulants or atomoxetine for ADHD for the study duration is exclusionary for this protocol. All other medications will undergo discontinuation.
- •Patients who are unable to comply with the study protocol.
- •Females of childbearing age that are sexually active and not receiving a medically acceptable form of birth control and/or active pregnancy.
- •Already taking Guanfacine Extended Release
排除标准
- 未提供
研究组 & 干预措施
GXR and Mindfulness Skills
Guanfacine Extended Release (GXR) will be started at 1 mg/day at Week 1 and tapered up by 1 mg per week to a maximum dose of 7 mg/day by week 7 (maximum of 6 weeks on drug). GXR dosing will be flexible for the first 5 weeks of the study based upon patient response and tolerability to drug. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.
干预措施: Guanfacine Extended Release (Drug)
GXR and Mindfulness Skills
Guanfacine Extended Release (GXR) will be started at 1 mg/day at Week 1 and tapered up by 1 mg per week to a maximum dose of 7 mg/day by week 7 (maximum of 6 weeks on drug). GXR dosing will be flexible for the first 5 weeks of the study based upon patient response and tolerability to drug. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.
干预措施: Mindfulness Skills Therapy (Behavioral)
Placebo and Mindfulness Skills
Placebo will be started at "1 mg/day" at Week 1 and tapered up by "1 mg" per week to a maximum dose of "7 mg/day" by week 7 (maximum of 6 weeks on drug). Placebo dosing will be flexible for the first 5 weeks of the study based upon patient response. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.
干预措施: Mindfulness Skills Therapy (Behavioral)
Placebo and Mindfulness Skills
Placebo will be started at "1 mg/day" at Week 1 and tapered up by "1 mg" per week to a maximum dose of "7 mg/day" by week 7 (maximum of 6 weeks on drug). Placebo dosing will be flexible for the first 5 weeks of the study based upon patient response. Optimal dose will be defined as that necessary to achieve ≥ 30% reduction in symptoms and a CGI-Improvement Score ≤ 2. Upon re-evaluation at (T1) and entry into the psychotherapy protocol dosing will become fixed for the remainder of the study. Mindfulness Skills Therapy will occur for the next 10 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in ADHD RS-IV
时间窗: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)
An 18-item caregiver-completed rating scale developed to measure the behaviors of youths with ADHD
Youth Self Report (CBCL)
时间窗: Completed at initial visit only (week 1)
Assesses self-report functioning and internalizing and externalizing symptoms. The YSR contains social competence items and 112 items assessing self-reported symptoms.
Changes in theRetrospective-Modified Overt Aggression Scale (R-MOAS)
时间窗: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2)(approximately 20 weeks in total)
(R-MOAS) assesses the frequency and severity of 16 aggressive behaviors over the past week in four areas: verbal aggression, physical aggression towards others, aggression toward oneself, and destruction or hostile misuse of property. Numeric weighting amplifies the seriousness of more harmful behaviors in the total score. Reliability and validity data on the instrument are published. A total score ≥ 24 is required to identify clinically significant aggression.
Changes in the Emotion Reactivity Scale (ERS)
时间窗: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total)
A 21-item self-report measure of emotion sensitivity, intensity, and persistence. The scale assesses emotional reactivity.
Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)
时间窗: Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) (approximately 20 weeks in total)
a self-report and observer-report instrument for youths 7-18 years that inventories 25 adverse childhood experiences and potentially traumatic events and assesses symptoms of post-traumatic stress disorder using the revised criteria published in DSM 5. Total score and DSM 5 domains B-E are included (intrusive symptoms, avoidance, cognitive-mood symptoms, arousal-reactivity symptoms and symptoms of dissociation).
Kaufman Brief Intelligence Test-2
时间窗: Completed by the adolescent at the initial visit only (week 1)
The KBIT is normed for ages 4-90 years and yields a verbal IQ, non-verbal IQ, and full-scale IQ.
次要结局
- Group Engagement Scale (GES)(At each of the Mindfulness Skills Therapy sessions if the subject is in group therapy.(approximately 10 weeks))
- Clinical Global Impressions Improvement Scale(Completed ater drug dose has been determined to be stable and fixed (T1) and after completing the Mindfulness Therapy (T2) and each medication management visit.(approximately 20 weeks in total))
- Clinical Global Impressions Severity Scale(Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management appointment(approximately 20 weeks in total))
- The Screen for Child Anxiety Related Emotional Disorders (SCARED)(Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2). Also at each medication management visit(approximately 20 weeks in total))
- Patient Health Questionnaire (PHQ-9)(Completed as part of the initial evaluation (T0), after drug dose has been determined to be stable and fixed (T1), and after completing the Mindfulness Therapy. (T2) Also at each medication management visit(approximately 20 weeks in total))
- Guanfacine Extended Release and Mindfulness Skills Therapy reducing traumatic stress(20 weeks)
- Client Credibility Questionnaire (CCQ)(the CCQ will be administered to all youth and parents at the end of session one following presentation of the treatment rationale(approximately 20 weeks in total))
- Tolerance of Guanfacine Extended Release in subjects between the ages of 12-17 years old.(20 weeks)
研究者
Asima Zehgeer
Assistant Professor
UConn Health