Mental Disorder, ChildNCT04029220
Navigation and Parent Peer Support to Promote Access
A study testing Parent Peer Navigation in people with Mental Disorder, Child and Mental Health, run by University of Colorado, Denver at 4 sites in United States.
Trial summary
Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Read more about this study
- Who is it for?
- Ages 1 year to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Child, Mental Health, Family Health
- What is being tested?
- Parent Peer Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- 18 Feb 2020to 31 Mar 2023
- 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 1 year to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PPN provider:
- Over the age of 18 years
- Has experience in providing PPN services to families
- Has lived experience of having a child with mental health challenges
- Employed by the collaborating Family Run Organization
- Parents/Caregivers:
Show all 12Show fewer
- Over the age of 18 years,
- Have a child aged 1-13 with significant mental health symptoms and impairment but who has had no formal mental health treatment
- Child:
- Aged 1-13 years
- Has significant mental health symptoms and impairment
- Has had no formal mental health treatment
Who cannot join
- PPN provider:
- None
- Parent:
- His or her child is in crisis needing more intense levels of care
- His or her child has been living continuously with parent for less than one year
- Child:
- In crisis needed more intense levels of care
- Has been living continuously with parent for less than one year
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Colorado School of Medicine
Aurora, Colorado, 80045-7106
Bruno J Anthony, PhD, 720-777-6255, bruno.anthony@ucdenver.edu
- Recruiting
Uplift Wyoming
Cheyenne, Wyoming, 82001
Michelle Heinen, 307-778-8686, mheinen@upliftwy.org
- Recruiting
Allegheny Family Network
Pittsburgh, Pennsylvania, 15213
Ruth Fox, 412-246-2030, rfox@alleghenyfamilynetwork.org
- Not yet recruiting
Oregon Family Support Network
Salem, Oregon, 97302
Sandy Bumpus, 503-363-8068, sandy.bumpus@ofsn.net
About this study
Official title: Navigation and Parent Peer Support to Promote Access and Retention of Children in Mental Health Services
Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.
Read the detailed description
Parent peer navigation (PPN), provided by other caregivers who have lived experience raising a youth with mental health conditions, holds promise as a service that can aid in improving both youth and caregiver outcomes by overcoming system- and individual-level barriers to care. This proposed study will support initial testing of a research- and theory- based Parent Peer Navigation (PPN) model created by one of the nation's leading advocacy organizations for caregivers of children and youth with mental health challenges, the federally funded Family-Run Executive Directors Leadership Association. This model, called the National Parent Peer Support Practice Model (Practice Model) has an associated training program and aims to effectively engage parents/caregivers in necessary treatment for their children by helping them connect with assessment, treatment and community-based resources and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support once the PPN provider is no longer involved. The Practice Model incorporates five theory- and research-based components of support: (1) information/educational, (2) instructional/skills development; (3) emotional/ affirming, (4) instrumental; and (5) advocacy. The study will focus on children in early stages of impairment as a result of mental health challenges for which prevention of further disability is possible. It will take advantage of implementation of the Practice Model through two non-profit family-run organizations (FROs) and will occur in three phases, beginning with preparatory work to develop recruitment strategies in collaboration with local schools, formalize implementation outcomes (acceptability, appropriateness, feasibility, fidelity) and other measures followed by a Feasibility Study to finalize recruitment, procedures and measurement frames. Finally, in Phase 3, the investigators will conduct a cluster randomized trial to provide a preliminary test of the impact of the Practice Model on key caregiver and child outcomes. Children who are experiencing mental health challenges but have not had exposure to formal mental health services will be identified by collaborating schools and FROs/FSOs and referred for family support. Consenting families will be randomly assigned to a treatment group who will receive PPN services based on the Practice Model from participating FROs, or a comparison group who will be referred to a Family Support Organization which provide other types of resources (e.g., referrals, information). The investigators predict that youth and parents receiving PPN will show significantly greater rates of access, engagement and retention in services as compared to the comparison group. The investigators also predict that at 6 months following PPN onset, children in the treatment group will exhibit improved social/emotional functioning and that parents in the treatment group will exhibit increased empowerment and decreased parenting stress, as compared to those in the comparison group.
- Conditions
- Mental Disorder, Child, Mental Health, Family Health
- Being tested
- Parent Peer Navigation
- Keywords
- Patient Navigation, Mental Health Services
- Medical subject headings
- Neurodevelopmental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Peer NavigationBehavioural
Parent Peer Navigation (PPN) is implemented by trained providers with lived experience, who are supported by training and coaching protocols. The role of PPN provider is to engage caregivers in necessary treatment for their children and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support. PPN providers will support families who are just entering he child-serving systems for 6 months on a weekly basis during which they will: help link families with formal and informal supports; instill confidence and coping skills; assist in the development of goals and crisis plans; and serve as an advocate for resolution of issues. Also, the PPN provider helps the family to learn to navigate systems and advocate for their needs, prepares families for meetings and treatment sessions, helps identify ways for parents to practice self-care; and promotes family choice and shared decision making.
| Study group | Role | What they receive |
|---|---|---|
| Parent Peer Navigation (PPN) by Family Run Organization | Experimental | In this arm, families receive PPN services from a trained provider with lived experience whose role is to effectively engage parents/caregivers in necessary treatment for their children by helping them connect with assessment, treatment and community-based resources and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support once the PPN is no longer involved. PPN providers use the foundational competencies and skills to educate, inform and support families who are just entering the child-serving systems due to emerging behavioral health issues of their child. Receives: Behavioral: Parent Peer Navigation |
| Resources provided by Family Support Organization | Active comparator | The active comparator is service provided by Family Support Organizations (FSOs), which provide information and resources for families about disabilities, special education and other services as well as workshops and parent support groups. Unlike PPN services, FSO staff members are not "veteran caregivers" of a child with mental health challenges, do not provide personalized service delivery, do not provide a comprehensive assessment of family needs, and do not prepare families to make use of services through support for their initial and continued involvement in them. Finally, whereas PPNs participate in comprehensive training and coaching, training for FSO staff tends to be more general and consists primarily of being aware of local resources to which families may be referred. Receives: Behavioral: Parent Peer Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Services Assessment for Children and Adolescents (SACA)
The Brief Form of the Services Assessment for Children and Adolescents (SACA) obtains for each service setting, information about the specific type of service used, provider, duration and frequency of use, and reason for use. Questions are asked not only about child involvement but those aspects of the service that require parent involvement.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (11)
Working Alliance Inventory - Short Form (WAI-S): Change is being assessed
Engagement in the PPN intervention will be assessed with the Working Alliance Inventory, Short Form (WAI-S), a 12-item adaptation of the Working Alliance Inventory to assess: (1) agreement on goals; (2) agreement on tasks; and (3) the development of bond. A total alliance score and subscales are available (goals, tasks, bond).
Measured: Baseline, 3 months, 6 months
Family Journey Assessment (FJA): Change is being assessed
The FJA completed by PPN providers and family members tracks caregiver progress toward self-advocacy and self-efficacy with a 3-component structure, reflecting progress in the recognition of needs, collaboration to access help from formal and natural supports, and activation of skills to cope with stress, enhance resilience, and develop and carry out plans of care.
Measured: Baseline, 3 months, 6 months
Family Empowerment Scale (FES): Change is being assessed
Two modules of the FES will be employed which measure parent's perception of their self-efficacy and competence in the context of mental health services. Each has shown to have adequate reliability and validity and to be a predictor of positive change in children's problem behavior.
Measured: Baseline, 3 months, 6 months
Social Support Questionnaire (SSQ): Change is being assessed
The revised short form of the Social Support Questionnaire is a 12-item instrument in which individuals are asked to list the people in their social network whom they perceive as helpful in six different areas and are also asked to rate their level of satisfaction with that support.
Measured: Baseline, 3 months, 6 months
The Revised Short Form of the Caregiver Strain Questionnaire (CSQ):Change is being assessed
Part of the Peabody Treatment Progress Battery, the revised short form of the CSQ is a 7-item scale that assesses the degree of objective and subjective stress experienced by a caregiver as a result of the responsibilities related to caring for a child with behavioral problems.
Measured: Baseline, 3 months, 6 months
Hope Scale: Change is being assessed
The Hope Scale measures positive beliefs about the future, with 12 items measuring a person's self-efficacy and strategic goal orientation with two subscales: (1) hope pathways: perceived ability to generate routes to surmount obstacles and obtain goals, and (2) hope agency: personal belief that one can initiate and sustain effort toward goals using selected routes.
Measured: Baseline, 3 months, 6 months
School attendance: Change is being assessed
Suspensions, expulsions and attendance will be obtained directly from school records with parent permission
Measured: Baseline, 3 months, 6 months
School suspension: Change is being assessed
Suspensions, expulsions and attendance will be obtained directly from school records with parent permission
Measured: Baseline, 3 months, 6 months
School expulsion: Change is being assessed
Suspensions, expulsions and attendance will be obtained directly from school records with parent permission
Measured: Baseline, 3 months, 6 months
Strengths and Difficulties Questionnaire (SDQ): Change is being assessed
The SDQ is a widely used, brief screening tool used with children ages 4 to 17 years. Included are 25 items covering behavioral/emotional symptoms evenly divided into five scales: Emotional Symptoms, Conduct Problems, Hyperactivity, Peer Problems, and Prosocial Behavior. The impact section addresses whether the relevant symptoms result in substantial functional impairment and impose significant family burden.
Measured: Baseline, 3 months, 6 months
Youth Top Problems: Change is being assessed
A psychometrically adequate measure that empirically-derives parents primary issues related to their child, tracking changes in child functioning over time.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start18 Feb 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Disorder, ChildStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will employ a randomized trial to provide a preliminary test of the impact of Parent Peer Navigation (PPN) on key caregiver and child outcomes. We will recruit children and families through schools and through those families contacting Family Run Organizations directly in Pennsylvania and Wyoming, who will then be referred randomly to either a (1) Family Support Organization or Service (FSO) that provides only information and referrals by staff who are not family members with lived experience or (2) one of the FROs (Allegheny Family Network in Pennsylvania or UPLIFT in Wyoming) that provides PPN by family members with lived experience..
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, University of Pittsburgh, Uplift Wyoming, Allegheny Family Network, Family-Run Executive Director Leadership Association, Oregon Family Support Network
- Responsible party
- Sponsor
- Investigators
- Bruno J. Anthony, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029220
- Sponsor's protocol ID
- 19-0972
- Other IDs
- R34MH119431
- Status last verified
- Aug 2022
- First submitted
- 17 Jul 2019
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anthony BJ, Serkin C, Kahn N, Troxel M, Shank J. Tracking progress in peer-delivered family-to-family support. Psychol Serv. 2019 Aug;16(3):388-401. doi: 10.1037/ser0000256. Epub 2018 Nov 1.
PubMed 30382742Holmes J, Dahlman T, Bruns EJ, Woody M, Hendricks M, Sweeney M, Anthony BJ. Partnering with Family Organizations in Research: Experiences from the Field. Int J Environ Res Public Health. 2025 Jun 3;22(6):894. doi: 10.3390/ijerph22060894.
PubMed 40566321
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigation and Parent Peer Support to Promote Access and Retention of Children in Mental Health Services
- ClinicalTrials.gov ID
- NCT04029220
- Acronym / sponsor ID
- 19-0972
- Conditions
- Mental Disorder, Child, Mental Health, Family Health
- Keywords
- Patient Navigation, Mental Health Services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Washington, University of Pittsburgh, Uplift Wyoming, Allegheny Family Network, Family-Run Executive Director Leadership Association, Oregon Family Support Network
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Jul 2019 (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.
Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.
Detailed description
Parent peer navigation (PPN), provided by other caregivers who have lived experience raising a youth with mental health conditions, holds promise as a service that can aid in improving both youth and caregiver outcomes by overcoming system- and individual-level barriers to care. This proposed study will support initial testing of a research- and theory- based Parent Peer Navigation (PPN) model created by one of the nation's leading advocacy organizations for caregivers of children and youth with mental health challenges, the federally funded Family-Run Executive Directors Leadership Association. This model, called the National Parent Peer Support Practice Model (Practice Model) has an associated training program and aims to effectively engage parents/caregivers in necessary treatment for their children by helping them connect with assessment, treatment and community-based resources and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support once the PPN provider is no longer involved. The Practice Model incorporates five theory- and research-based components of support: (1) information/educational, (2) instructional/skills development; (3) emotional/ affirming, (4) instrumental; and (5) advocacy. The study will focus on children in early stages of impairment as a result of mental health challenges for which prevention of further disability is possible. It will take advantage of implementation of the Practice Model through two non-profit family-run organizations (FROs) and will occur in three phases, beginning with preparatory work to develop recruitment strategies in collaboration with local schools, formalize implementation outcomes (acceptability, appropriateness, feasibility, fidelity) and other measures followed by a Feasibility Study to finalize recruitment, procedures and measurement frames. Finally, in Phase 3, the investigators will conduct a cluster randomized trial to provide a preliminary test of the impact of the Practice Model on key caregiver and child outcomes. Children who are experiencing mental health challenges but have not had exposure to formal mental health services will be identified by collaborating schools and FROs/FSOs and referred for family support. Consenting families will be randomly assigned to a treatment group who will receive PPN services based on the Practice Model from participating FROs, or a comparison group who will be referred to a Family Support Organization which provide other types of resources (e.g., referrals, information). The investigators predict that youth and parents receiving PPN will show significantly greater rates of access, engagement and retention in services as compared to the comparison group. The investigators also predict that at 6 months following PPN onset, children in the treatment group will exhibit improved social/emotional functioning and that parents in the treatment group will exhibit increased empowerment and decreased parenting stress, as compared to those in the comparison group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will employ a randomized trial to provide a preliminary test of the impact of Parent Peer Navigation (PPN) on key caregiver and child outcomes. We will recruit children and families through schools and through those families contacting Family Run Organizations directly in Pennsylvania and Wyoming, who will then be referred randomly to either a (1) Family Support Organization or Service (FSO) that provides only information and referrals by staff who are not family members with lived experience or (2) one of the FROs (Allegheny Family Network in Pennsylvania or UPLIFT in Wyoming) that provides PPN by family members with lived experience..
| Arm | Type | Receives |
|---|---|---|
| Parent Peer Navigation (PPN) by Family Run Organization | Experimental | Behavioral: Parent Peer NavigationIn this arm, families receive PPN services from a trained provider with lived experience whose role is to effectively engage parents/caregivers in necessary treatment for their children by helping them connect with assessment, treatment and community-based resources and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support once the PPN is no longer involved. PPN providers use the foundational competencies and skills to educate, inform and support families who are just entering the child-serving systems due to emerging behavioral health issues of their child. |
| Resources provided by Family Support Organization | Active comparator | Behavioral: Parent Peer NavigationThe active comparator is service provided by Family Support Organizations (FSOs), which provide information and resources for families about disabilities, special education and other services as well as workshops and parent support groups. Unlike PPN services, FSO staff members are not "veteran caregivers" of a child with mental health challenges, do not provide personalized service delivery, do not provide a comprehensive assessment of family needs, and do not prepare families to make use of services through support for their initial and continued involvement in them. Finally, whereas PPNs participate in comprehensive training and coaching, training for FSO staff tends to be more general and consists primarily of being aware of local resources to which families may be referred. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Over the age of 18 years
- Has experience in providing PPN services to families
- Has lived experience of having a child with mental health challenges
- Employed by the collaborating Family Run Organization
- Over the age of 18 years,
Key exclusion criteria (8 listed)
- None
- His or her child is in crisis needing more intense levels of care
- His or her child has been living continuously with parent for less than one year
- In crisis needed more intense levels of care
- Has been living continuously with parent for less than one year
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 |
|---|---|---|
| Parent Peer NavigationParent Peer Navigation (PPN) is implemented by trained providers with lived experience, who are supported by training and coaching protocols. The role of PPN provider is to engage caregivers in necessary treatment for their children and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support. PPN providers will support families who are just entering he child-serving systems for 6 months on a weekly basis during which they will: help link families with formal and informal supports; instill confidence and coping skills; assist in the development of goals and crisis plans; and serve as an advocate for resolution of issues. Also, the PPN provider helps the family to learn to navigate systems and advocate for their needs, prepares families for meetings and treatment sessions, helps identify ways for parents to practice self-care; and promotes family choice and shared decision making. | Behavioural | Parent Peer Navigation (PPN) by Family Run Organization, Resources provided by Family Support Organization |
Primary outcome
Change in Services Assessment for Children and Adolescents (SACA)
Time frame: Baseline, 3 months and 6 months
The Brief Form of the Services Assessment for Children and Adolescents (SACA) obtains for each service setting, information about the specific type of service used, provider, duration and frequency of use, and reason for use. Questions are asked not only about child involvement but those aspects of the service that require parent involvement.
11 secondary outcomes
Working Alliance Inventory - Short Form (WAI-S): Change is being assessed
Time frame: Baseline, 3 months, 6 months
Family Journey Assessment (FJA): Change is being assessed
Time frame: Baseline, 3 months, 6 months
Family Empowerment Scale (FES): Change is being assessed
Time frame: Baseline, 3 months, 6 months
Social Support Questionnaire (SSQ): Change is being assessed
Time frame: Baseline, 3 months, 6 months
The Revised Short Form of the Caregiver Strain Questionnaire (CSQ):Change is being assessed
Time frame: Baseline, 3 months, 6 months
Hope Scale: Change is being assessed
Time frame: Baseline, 3 months, 6 months
School attendance: Change is being assessed
Time frame: Baseline, 3 months, 6 months
School suspension: Change is being assessed
Time frame: Baseline, 3 months, 6 months
School expulsion: Change is being assessed
Time frame: Baseline, 3 months, 6 months
Strengths and Difficulties Questionnaire (SDQ): Change is being assessed
Time frame: Baseline, 3 months, 6 months
Youth Top Problems: Change is being assessed
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Background: PubMed 30382742Anthony BJ, Serkin C, Kahn N, Troxel M, Shank J. Tracking progress in peer-delivered family-to-family support. Psychol Serv. 2019 Aug;16(3):388-401. doi: 10.1037/ser0000256. Epub 2018 Nov 1.
- Derived from this study: PubMed 40566321Holmes J, Dahlman T, Bruns EJ, Woody M, Hendricks M, Sweeney M, Anthony BJ. Partnering with Family Organizations in Research: Experiences from the Field. Int J Environ Res Public Health. 2025 Jun 3;22(6):894. doi: 10.3390/ijerph22060894.
- 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.
Bruno J. Anthony, PhD principal investigator
University of Colorado, Denver
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Peer Navigation in people with Mental Disorder, Child and Mental Health, run by University of Colorado, Denver at 4 sites 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 8 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: status not confirmed, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Anthony (1-800-624-6553 ext. 6255, bruno.anthony@ucdenver.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Services Assessment for Children and Adolescents (SACA) (time frame: Baseline, 3 months and 6 months). 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 NCT04029220, which also lists 2 linked publications.
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 17 Aug 2022.