Externalizing BehaviorNCT07445867
Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk
A study testing Summer Academy in people with Externalizing Behavior, run by Florida International University at 1 site in United States.
Trial summary
This study is a program evaluation or open-trial study of the effectiveness of Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Externalizing Behavior
- What is being tested?
- Summer Academy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2016to 1 Sep 2021
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children were:
- transitioning to kindergarten the following school year;
- had behavioral, learning, attention, or other social emotional difficulties, as evidenced by meeting diagnostic criteria for a behavioral or emotional disorder (e.g., Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder) or qualify for special education services via an Individualized Education Program (IEP);
- had the cognitive and language skills needed to appropriately benefit from the program; and
- be able to attend the 7-week intervention program with weekly parent training.
Who cannot join
- Child did not meet any of the inclusion criteria above,
- Child was not residing with their legal guardian.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University, Center for Children and Families
Miami, Florida, 33199
About this study
This study is a program evaluation or open-trial study of the effectiveness of Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.
Read the detailed description
Research design
This study is a program evaluation or open-trial study of the effectiveness of FIU Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.
There will be two phases to this study. The first phase (Phase I) will include a series of focus groups to be held annually with parents, teachers, and community stakeholders to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness. The second phase (Phase II), will consist of direct program evaluation.
Procedures to be used
In Phase I, we will recruit parents, teachers, and community stakeholders to participate in a 1 hour focus group to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness.
In Phase II, children and their families will be recruited to participate in the summer program through direct school and community referrals. Several process measures (e.g., attendance, satisfaction ratings) will be used to determine the feasibility of the intervention. Other outcome measures, obtained via multiple reports (i.e., parent, teacher, \& observations), examining children's behavioral functioning, self-regulation skills, parental involvement, and academic achievement will be used to both examine aspects of treatment integrity and the effects of the various components of the intervention.
- Conditions
- Externalizing Behavior
- Being tested
- Summer Academy
- Keywords
- early intervention, Summer Treatment Program Adaptations, ADHD, externalizing behavior problems, underserved populations
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Summer AcademyBehavioural
Also called STP-PreK
All children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \& Hart, 2016; Hart, Maharaj, \& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to be responsive to community needs. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018).
| Study group | Role | What they receive |
|---|---|---|
| Summer Academy | Experimental | All children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \& Hart, 2016; Hart, Maharaj, \& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to meet the needs of the community. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018). Receives: Behavioral: Summer Academy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Functioning
Caregivers completed the Behavior Assessment System for Children, 3rd Edition (BASC-3; Reynolds \& Kamphaus, 2018). The BASC-3 is a widely used behavior checklist that taps emotional and behavioral domains of children's functioning. The parent version used for preschool children contains 139 items.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Behavioral Symptomatology
Symptoms of ADHD, ODD, and Early Conduct Symptoms were measured at each time point using the parent Disruptive Behavior Disorder (DBD) Rating Scale (Pelham et al., 1992). The DBD consists of 45-items that correspond with DSM diagnostic symptomatology for ADHD-Inattention (9 items), ADHD-hyperactivity/impulsivity (9 items), ODD (8 items) and Conduct Disorder (15 items). Caregivers rate each item on a four-point scale (not at all, just a little, pretty much, very much). Items rated as pretty much or very much are considered as positive, or endorsed, symptoms.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Behavioral Impairment
Caregivers completed the Impairment Rating Scale (IRS; Fabiano, et al., 2006) at all three assessment time points. The IRS measures the severity of impairment caused by children's difficulty across several domains of functioning (e.g., academic functioning, family functioning, relationships parents, overall) on a 7-point scale, ranging from 0 (no impairment) to 6 (extreme impairment).
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Pre-academic skills
Through direct child testing, pre-academic skills were measured at each time point using the Bracken School Readiness Assessment (BSRA; Bracken, 2002). The BRSA is a measure for children pre-k to 2nd grade and assesses several school readiness domains (i.e., receptive knowledge of colors, shapes, numbers, letters, and spatial/size relations).
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Executive functioning
At each time point, the Head-Toes-Knees-Shoulders task (HTKS; Ponitz et al., 2009) was administered. The HTKS is a tool to objectively measure executive functioning executive functioning skills in preschool children. The HTKS has been widely used with good psychometrics (Ponitz et al., 2009; Wanless et al., 2011) and validated in a sample of preschool children with externalizing behavior problems (Graziano et al., 2015). The HTKS task prompts children to perform paired behavioral responses in the opposite way (e.g., when I say "touch your head" touch your toes). Scores range from 0 to 60, with 2 points for initial accurate opposite responses, 1 point for self-corrected responses, and 0 points for inaccurate responses. Higher scores indicate more developed executive functioning skills.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Parenting Practices
The Alabama Parenting Questionnaire-Preschool Version (APQ-PR; Shelton, Frick, \& Wootton, 1996) will be completed at each time point and consists of 42 items that are designed to measure parenting practices across five domains: parental involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment. Ratings of the items are made on a 5-point scale (never, almost never, sometimes, often, always). The APQ has good psychometric properties, including criterion validity in differentiating clinical and nonclinical groups (Frick, Christian, \& Wootton, 1999; Shelton et al., 1996) and has been used with parents of children as young as three years of age (Clerkins, Marks, Policaro, \& Halperin, 2007).
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Parenting Stress
The Parenting Stress Index-Short Form (PSI-SF; Abidin, 1983) will be completed at each time point and is a 36-item self-report instrument for parents of children ages 1 month to 12 years containing three subscales (Parent Distress, Parent-Child Dysfunctional Interaction, Difficult Child) with Cronbach's alphas of .87, .80, and .85, respectively, and 6-month test-retest reliabilities of 0.85, 0.68, and 0.78, respectively (Abidin, 1983). The PSI and the PSI-SF total scores are highly correlated with one another (.94). On the long form of the PSI, higher scores have been associated with increased severity of conduct-disordered behavior (Eyberg, Boggs, \& Rodriguez, 1992; Ross, Blanc, McNeil, Eyberg, \& Hembree-Kigin, 1998). The PSI-SF will be used to assess the effects of PCIT on parent stress.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Parent-Child Interaction
The Dyadic Parent-Child Interaction Coding System-Third Edition (DPICS-III; Eyberg, Nelson, Duke, \& Boggs, 2005) is a behavioral coding system that measures the quality of parent-child interactions during three 5-minutes standard situations that vary in the degree of parental control (i.e., child-led play, parent-led play, and clean-up), as well as during during a shared-reading task. The convergent and discriminative validity of the DPICS categories have been extensively documented and the psychometric data are summarized in the DPICS manual (Eyberg et al., 2004). A copy of the DPICS-III manual is not included with this proposal due to its extremely large size (260 pages). The manual is not given to participants; it is only used when coding the videotaped parent-child interactions. The manual is available on line at www.pcit.org for review. For the current study, parent and child behaviors will be measured to examine changes in the parent-child relationship and literacy engagement.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Secondary outcomes (1)
Parent perceptions of education
The Parent Perceptions of Education is a 38-item measure comprised of five previously developed scales (Hoover-Dempsey \& Sandler, 2005; Walker, Wilkins, Dallaire, Sandler, \& Hoover-Dempsey, 2005) will be completed by parents pre- and post-intervention to assess the following aspects of parental role in the facilitation of early learning: (a) parents' beliefs about their efficacy for helping their children succeed in school; (b) parents' beliefs about involvement in the child's education; (c) parents' beliefs about personal knowledge and skills for involvement in the child's education; (d) parents' perceptions about how much time and energy they perceive they have for engaging in school related activities; and (e) parent's attraction to or general disposition toward schools, based on his or her prior personal experience with schools.
Measured: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start16 Mar 2016
- Primary completion1 Sep 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Externalizing BehaviorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Responsible party
- Sponsor
- Investigators
- Katie Hart, Ph.D., Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445867
- Sponsor's protocol ID
- IRB-16-0101
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk
- ClinicalTrials.gov ID
- NCT07445867
- Acronym / sponsor ID
- IRB-16-0101
- Conditions
- Externalizing Behavior
- Keywords
- early intervention, Summer Treatment Program Adaptations, ADHD, externalizing behavior problems, underserved populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- The Children's Trust, Miami FL
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Mar 2026 (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.
This study is a program evaluation or open-trial study of the effectiveness of Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.
Detailed description
Research design
This study is a program evaluation or open-trial study of the effectiveness of FIU Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.
There will be two phases to this study. The first phase (Phase I) will include a series of focus groups to be held annually with parents, teachers, and community stakeholders to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness. The second phase (Phase II), will consist of direct program evaluation.
Procedures to be used
In Phase I, we will recruit parents, teachers, and community stakeholders to participate in a 1 hour focus group to obtain feedback on the program to determine what, if any changes, need to be made to current programming to maximize effectiveness.
In Phase II, children and their families will be recruited to participate in the summer program through direct school and community referrals. Several process measures (e.g., attendance, satisfaction ratings) will be used to determine the feasibility of the intervention. Other outcome measures, obtained via multiple reports (i.e., parent, teacher, \& observations), examining children's behavioral functioning, self-regulation skills, parental involvement, and academic achievement will be used to both examine aspects of treatment integrity and the effects of the various components of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Summer Academy | Experimental | Behavioral: Summer AcademyAll children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \& Hart, 2016; Hart, Maharaj, \& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to meet the needs of the community. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children were:
Key exclusion criteria (2 listed)
- Child did not meet any of the inclusion criteria above,
- Child was not residing with their legal guardian.
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 |
|---|---|---|
| Summer AcademyAlso: STP-PreKAll children received a seven-week comprehensive school readiness program adapted from the STP-PreK program (Graziano \& Hart, 2016; Hart, Maharaj, \& Graziano, 2019) that ran from June to early August over the course of three summers. Summer Academy followed the behavioral, social-emotional, academic, and recreational intervention procedures consistent with STP-PreK, including procedures and structure of staff training and supervision, but differed in programmatic aspects in several key ways that were made to be responsive to community needs. Caregivers were required to attend weekly caregiver groups following a modified School Readiness Parent Program (SRPP; Graziano et al., 2018). | Behavioural | Summer Academy |
Primary outcome
Behavioral Functioning
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Caregivers completed the Behavior Assessment System for Children, 3rd Edition (BASC-3; Reynolds \& Kamphaus, 2018). The BASC-3 is a widely used behavior checklist that taps emotional and behavioral domains of children's functioning. The parent version used for preschool children contains 139 items.
Behavioral Symptomatology
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Symptoms of ADHD, ODD, and Early Conduct Symptoms were measured at each time point using the parent Disruptive Behavior Disorder (DBD) Rating Scale (Pelham et al., 1992). The DBD consists of 45-items that correspond with DSM diagnostic symptomatology for ADHD-Inattention (9 items), ADHD-hyperactivity/impulsivity (9 items), ODD (8 items) and Conduct Disorder (15 items). Caregivers rate each item on a four-point scale (not at all, just a little, pretty much, very much). Items rated as pretty much or very much are considered as positive, or endorsed, symptoms.
Behavioral Impairment
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Caregivers completed the Impairment Rating Scale (IRS; Fabiano, et al., 2006) at all three assessment time points. The IRS measures the severity of impairment caused by children's difficulty across several domains of functioning (e.g., academic functioning, family functioning, relationships parents, overall) on a 7-point scale, ranging from 0 (no impairment) to 6 (extreme impairment).
Pre-academic skills
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Through direct child testing, pre-academic skills were measured at each time point using the Bracken School Readiness Assessment (BSRA; Bracken, 2002). The BRSA is a measure for children pre-k to 2nd grade and assesses several school readiness domains (i.e., receptive knowledge of colors, shapes, numbers, letters, and spatial/size relations).
Executive functioning
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
At each time point, the Head-Toes-Knees-Shoulders task (HTKS; Ponitz et al., 2009) was administered. The HTKS is a tool to objectively measure executive functioning executive functioning skills in preschool children. The HTKS has been widely used with good psychometrics (Ponitz et al., 2009; Wanless et al., 2011) and validated in a sample of preschool children with externalizing behavior problems (Graziano et al., 2015). The HTKS task prompts children to perform paired behavioral responses in the opposite way (e.g., when I say "touch your head" touch your toes). Scores range from 0 to 60, with 2 points for initial accurate opposite responses, 1 point for self-corrected responses, and 0 points for inaccurate responses. Higher scores indicate more developed executive functioning skills.
Parenting Practices
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
The Alabama Parenting Questionnaire-Preschool Version (APQ-PR; Shelton, Frick, \& Wootton, 1996) will be completed at each time point and consists of 42 items that are designed to measure parenting practices across five domains: parental involvement, positive parenting, poor monitoring/supervision, inconsistent discipline, and corporal punishment. Ratings of the items are made on a 5-point scale (never, almost never, sometimes, often, always). The APQ has good psychometric properties, including criterion validity in differentiating clinical and nonclinical groups (Frick, Christian, \& Wootton, 1999; Shelton et al., 1996) and has been used with parents of children as young as three years of age (Clerkins, Marks, Policaro, \& Halperin, 2007).
Parenting Stress
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
The Parenting Stress Index-Short Form (PSI-SF; Abidin, 1983) will be completed at each time point and is a 36-item self-report instrument for parents of children ages 1 month to 12 years containing three subscales (Parent Distress, Parent-Child Dysfunctional Interaction, Difficult Child) with Cronbach's alphas of .87, .80, and .85, respectively, and 6-month test-retest reliabilities of 0.85, 0.68, and 0.78, respectively (Abidin, 1983). The PSI and the PSI-SF total scores are highly correlated with one another (.94). On the long form of the PSI, higher scores have been associated with increased severity of conduct-disordered behavior (Eyberg, Boggs, \& Rodriguez, 1992; Ross, Blanc, McNeil, Eyberg, \& Hembree-Kigin, 1998). The PSI-SF will be used to assess the effects of PCIT on parent stress.
Parent-Child Interaction
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
The Dyadic Parent-Child Interaction Coding System-Third Edition (DPICS-III; Eyberg, Nelson, Duke, \& Boggs, 2005) is a behavioral coding system that measures the quality of parent-child interactions during three 5-minutes standard situations that vary in the degree of parental control (i.e., child-led play, parent-led play, and clean-up), as well as during during a shared-reading task. The convergent and discriminative validity of the DPICS categories have been extensively documented and the psychometric data are summarized in the DPICS manual (Eyberg et al., 2004). A copy of the DPICS-III manual is not included with this proposal due to its extremely large size (260 pages). The manual is not given to participants; it is only used when coding the videotaped parent-child interactions. The manual is available on line at www.pcit.org for review. For the current study, parent and child behaviors will be measured to examine changes in the parent-child relationship and literacy engagement.
1 secondary outcome
Parent perceptions of education
Time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Katie Hart, Ph.D. principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Summer Academy in people with Externalizing Behavior, run by Florida International University 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 3 Mar 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Behavioral Functioning (time frame: From enrollment until the end of intervention at 7 weeks and then again at six months follow up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.