Stress DisorderPhase 4NCT03258476

Guanfacine Extended Release and Mindfulness Skills Therapy

A Phase 4 study testing Guanfacine Extended Release and Mindfulness Skills Therapy in people with Stress Disorder, run by UConn Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 10 to 20 years
Conditions the study is for: Stress Disorder
What is being tested?: Guanfacine Extended Release and Mindfulness Skills Therapy
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2019to 3 Dec 2019
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.
AND/OR
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

Show all 12Show fewer

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.

Who cannot join

:• 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

Trial locations and contacts

1 site in 1 country.

United States1 site

UConn Health
Farmington, Connecticut, 06030

Other trials in United States

About this study

Official title: Guanfacine Extended Release and Mindfulness in Traumatically Stressed Children and Adolescents Study

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.

Conditions: Stress Disorder
Being tested: Guanfacine Extended Release, Mindfulness Skills Therapy, Placebo
Medical subject headings: Stress Disorders, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guanfacine Extended ReleaseDrug
Also called Intuniv
Intuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths
Mindfulness Skills TherapyBehavioural
Mindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts
PlaceboDrug
Placebo oral capsule

Study groups in NCT03258476
Study group	Role	What they receive
GXR and Mindfulness Skills	Experimental	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. Receives: Drug: Guanfacine Extended Release; Behavioral: Mindfulness Skills Therapy
Placebo and Mindfulness Skills	Active comparator	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. Receives: Behavioral: Mindfulness Skills Therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)
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).
Measured: 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)
Changes in theRetrospective-Modified Overt Aggression Scale (R-MOAS)
(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.
Measured: 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)
Changes in ADHD RS-IV
An 18-item caregiver-completed rating scale developed to measure the behaviors of youths with ADHD
Measured: 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)
Changes in the Emotion Reactivity Scale (ERS)
A 21-item self-report measure of emotion sensitivity, intensity, and persistence. The scale assesses emotional reactivity.
Measured: 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)
Youth Self Report (CBCL)
Assesses self-report functioning and internalizing and externalizing symptoms. The YSR contains social competence items and 112 items assessing self-reported symptoms.
Measured: Completed at initial visit only (week 1)
Kaufman Brief Intelligence Test-2
The KBIT is normed for ages 4-90 years and yields a verbal IQ, non-verbal IQ, and full-scale IQ.
Measured: Completed by the adolescent at the initial visit only (week 1)

Secondary outcomes (8)

Guanfacine Extended Release and Mindfulness Skills Therapy reducing traumatic stress
1. To measure whether Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo will help diminish traumatic stress-related symptoms of concentration difficulties, aggression and anger, irritability, anxiety, fear, and depression in 12-17 year old youths who have experienced lifetime traumatic stress as assessed by clinician-reports, and observer- and self-reports on psychometrically validated rating scales.
Measured: 20 weeks
Tolerance of Guanfacine Extended Release in subjects between the ages of 12-17 years old.
1. To measure how well 12-17 year-old children tolerate Guanfacine Extended Release (GXR) 1-7 mg/daily compared to placebo. Tolerance assessed by review of adverse events.
Measured: 20 weeks
Clinical Global Impressions Improvement Scale
The CGI-Improvement scale assesses patient overall improvement of symptoms compared with symptoms at study baseline. It is rated on a 7-point scale with scores ranging between 1 ("very much improved), 2 ("improved"), 3 ("minimally improved"), 4 ("no change from baseline") to 7 ("very much worse").
Measured: 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
The CGI-Severity scale assesses the overall severity of a patient's psychiatric condition on a 7-point scale with scores ranging from 1 ("not ill") to 7 ("extremely severe").
Measured: 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)
Client Credibility Questionnaire (CCQ)
measures youth and parent expectancies of treatment
Measured: 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)
Group Engagement Scale (GES)
20-item scale, that assesses youth attitude/satisfaction toward their specific group. Each item is rated on a 9-point scale. Groups can prompt different attitudes among group members which can affect the effectiveness of the intervention. The GES yields high alphas (>0.9). (Those receiving individual Mindfulness will not receive this scale)
Measured: At each of the Mindfulness Skills Therapy sessions if the subject is in group therapy.(approximately 10 weeks)
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
a 41-item self or observer-completed screen for child and adolescent anxiety disorders. Sub-scores assess for the presence of panic disorder, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and significant school avoidance. Total scores ≥ 25 may indicate the presence of an anxiety disorder.
Measured: 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)
a 9-item self-report instrument assessing symptoms of depression. In clinically referred populations a total score ≥ 10 may identify clinically significant depression given the higher base-rate of depression in clinical populations than in epidemiological samples.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20193 Dec 2019

First posted23 Aug 2017
Study start1 Mar 2019
Primary completion3 Dec 2019
Study completion3 Dec 2019

Why it stopped: Contract terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stress DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: The proposed study has two parts: (1) a randomized, double-blind controlled clinical trial of GXR vs. placebo for up to 7 weeks followed by, (2) 10 weeks of either GXR and Mindfulness psychotherapy (as a group or individual) or placebo and Mindfulness psychotherapy (as a group or individual).
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03258476
Sponsor's protocol ID: 17-080-2
Status last verified: Mar 2021
First submitted: 24 May 2017
Last updated: 8 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: This is a multi center study being conducted in collaboration with Yale University. All shared data will be coded, with the code being held exclusively by the original contributing institute.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Stress Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guanfacine Extended Release and Mindfulness in Traumatically Stressed Children and Adolescents Study
ClinicalTrials.gov ID: NCT03258476
Acronym / sponsor ID: 17-080-2
Conditions: Stress Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Contract terminated
Enrolment: 0 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: Shire, Yale University
Study start: 1 Mar 2019 (actual)
Primary completion: 3 Dec 2019 (actual)
Study completion: 3 Dec 2019 (actual)
First posted: 23 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: The proposed study has two parts: (1) a randomized, double-blind controlled clinical trial of GXR vs. placebo for up to 7 weeks followed by, (2) 10 weeks of either GXR and Mindfulness psychotherapy (as a group or individual) or placebo and Mindfulness psychotherapy (as a group or individual).

Arm	Type	Receives
GXR and Mindfulness Skills	Experimental	Drug: Guanfacine Extended Release, Behavioral: Mindfulness Skills TherapyGuanfacine 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.
Placebo and Mindfulness Skills	Active comparator	Behavioral: Mindfulness Skills Therapy, Drug: PlaceboPlacebo 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.

Who may qualify

Ages: 10 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

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.
AND/OR
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

Key exclusion criteria (6 listed)

:• 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guanfacine Extended ReleaseAlso: IntunivIntuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths	Drug	GXR and Mindfulness Skills
Mindfulness Skills TherapyMindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts	Behavioural	GXR and Mindfulness Skills, Placebo and Mindfulness Skills
PlaceboPlacebo oral capsule	Drug	Placebo and Mindfulness Skills

Primary outcome

Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS)
Time frame: 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).
Changes in theRetrospective-Modified Overt Aggression Scale (R-MOAS)
Time frame: 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 ADHD RS-IV
Time frame: 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
Changes in the Emotion Reactivity Scale (ERS)
Time frame: 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.
Youth Self Report (CBCL)
Time frame: 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.
Kaufman Brief Intelligence Test-2
Time frame: 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.

8 secondary outcomes

Guanfacine Extended Release and Mindfulness Skills Therapy reducing traumatic stress
Time frame: 20 weeks
Tolerance of Guanfacine Extended Release in subjects between the ages of 12-17 years old.
Time frame: 20 weeks
Clinical Global Impressions Improvement Scale
Time frame: 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
Time frame: 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)
Client Credibility Questionnaire (CCQ)
Time frame: 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)
Group Engagement Scale (GES)
Time frame: At each of the Mindfulness Skills Therapy sessions if the subject is in group therapy.(approximately 10 weeks)
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: 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)
Time frame: 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)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
Individual participant dataSharing planned: Yes. This is a multi center study being conducted in collaboration with Yale University. All shared data will be coded, with the code being held exclusively by the original contributing institute.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Asima F Zehgeer, MD principal investigator

UConn Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Guanfacine Extended Release and Mindfulness Skills Therapy in people with Stress Disorder, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Structured Trauma-Related Experiences and Symptoms Screener (STRESS) (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03258476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.