Adolescent Well-BeingNCT06498427
Adolescents' Well-being in Community-based Treatment Versus Residential Treatment
An observational study of Adolescent Well-Being and Mental Disorders, Severe, run by Outcome Referrals, Inc. at 1 site in United States.
Trial summary
This is a quasi-experimental longitudinal study to compare the outcomes of youth in a Psychiatric Residential Treatment Facility (PRTF) compared to youth in the community-based Child-Focused Assertive Community Treatment Team [Child ACTT] program. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Well-Being, Mental Disorders, Severe
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 20 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be recruited from PRTF and Child ACTT. For example, the MCO reported these data from 2020: 131 unique members were served in PRTFs. Their summary demographic characteristics for gender, race, and age were as follows: 43.5 percent female and 55.7 percent male; 18 percent Black, 78 percent White, 3 percent Other and an average age of 14.5 years. Potential primary diagnoses expected are major depressive disorders, psychotic disorders, anxiety disorders, disruptive behavior disorders and bipolar disorder.
Who may be able to join
- Between the ages 12 and 18
- Has primary mental health diagnosis
- Admitted for treatment in a participating program (i.e., Psychiatric Residential Treatment Facility (PRTF) or Child ACTT)
- A trained ORI staff member determines that the youth is able to understand and sign an assent for participation
- Documentation of the youth's assent to participate in the study
- A legal guardian provides consent for the youth to participate in the study
Who cannot join
- The client is not admitted to treatment in a participating program
- The client has dropped out of this study during a previous treatment episode
- Client does not initiate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Outcome Referrals, Inc.
Framingham, Massachusetts, 01701
About this study
Official title: A Quasi-experimental Longitudinal Study of Adolescents' Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility (PRTF)
This is a quasi-experimental longitudinal study to compare the outcomes of youth in a Psychiatric Residential Treatment Facility (PRTF) compared to youth in the community-based Child-Focused Assertive Community Treatment Team [Child ACTT] program. The hypothesis is that Child ACTT will be associated with better outcomes and lower cost than PRTF among adolescents admitted to Child ACTT or PRTF.
Read the detailed description
Psychiatric Residential Treatment Facility (PRTF) care is expensive, removes adolescents from their communities, and is not necessarily effective. Managed care organizations (MCO) are exploring other methods of providing intensive care at home. Several states (e.g., Maine, Minnesota, Florida) have initiated and maintained Youth -Assertiveness Community Treatment (ACT) programs that are adapted from the evidence-based adult ACT model. Children's Hope Alliance (CHA) has been offering the Child-Focused Assertive Community Treatment Team [Child ACTT] Program as a service for potential clients since December 2019.
RECRUITMENT PROCEDURES
- The MCO will send a letter to PRTF treatment providers to inform them about this study.
- CHA and the PRTFs will inform the legal guardians of children who meet the inclusion criteria about a potential study opportunity.
- If the legal guardian verbally consents to being contacted by Outcome Referrals, Inc. (ORI) about the study, CHA or PRTF will forward the contact information for the legal guardian of the eligible participant to ORI via an encrypted email.
- ORI will contact the legal guardian to describe the study and review the eligibility criteria with potential participants (within 5 days of treatment authorization).
Individuals who meet the eligibility criteria and are interested in participating in the study will be sent electronic copies of the assent and consent forms to review and sign. ORI will inform the original referral source (CHA or specific PRTF) if the family is not able to be contacted or does not consent for study.
METHODS AND PROCEDURES
A randomized controlled trial was originally selected as the study design for this project because it is the gold standard for testing for causality; however, given recruitment issues, it was decided to transition to a quasi-experimental study instead. Although the investigators cannot conclude that one treatment is more efficacious than another, this quasi-experimental longitudinal study will provide important comparative information about these two treatment options for high need youth and families.
After study assent and consent forms are received by ORI, ORI will inform the referral source (CHA or PRTF) that the family consented to participate in the study: CHA or the PRTF will provide ORI with the contact information for the case manager at the facility for each participant. ORI will send an email to the case manager to inform them of that client's participation and request a time to train them on study assessment procedures.
ORI will administer a) the electronic assents and consents through an e-signature platform, and b) study assessments to both participants and their legal guardians during and post-treatment through ORI's secure platform, WellnessCheck.net.
- Conditions
- Adolescent Well-Being, Mental Disorders, Severe
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Child ACTT - Experimental | Excerpt from the Partners Child ACTT service definition in North Carolina (Revised 5-23-19): Program Requirements: Child ACTT (Assertive Community Treatment Team) is a team-based multi-disciplinary approach to serve children in their homes, kinships placements, foster homes ... The team will have daily meetings to prioritize activities, share information, and discuss individual members. The team will be available to respond 24/7 for crisis de-escalation and assessment, inclusive of availability by phone within 15 minutes and face to face within no more than 2 hours. This will include face-to-face assessment by a clinician, or nurse if this is determined to be needed for the individual. The psychiatric provider will be available minimally by phone 24/7 for consultation and treatment recommendations. The team will assess the overall needs of the family to ensure that all necessary treatment and supports are in place for entire family system. | |
| PRTF - Treatment as Usual | Psychiatric Residential Treatment Facilities (PRTFs) are non-hospital facilities intended to provide inpatient services to Medicaid-eligible individuals who are under the age of 21. A PRTF's mission is to either improve residents' condition or prevent further regression to ultimately remove the need for such services. PRTFs provide a range of comprehensive services intended to treat residents' psychiatric conditions under the supervision and direction of a psychiatrist. The core components in a PRTF program include at least weekly medication management, 24 hours nursing services, high staff-to-client ratio with awake staff during night hours, individual, group, and family therapy, intensive psychoeducation, behavioral model of care designed to teach new functional skills, and comprehensive assessments as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale.
The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
Measured: Study intervention endpoint (discharge or 6 months)
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Post-discharge Follow-up
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale.
The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
Measured: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
Secondary outcomes (7)
Satisfaction Score From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses patient satisfaction with behavioral health care. It includes 4 Likert scale items about satisfaction with treatment. Scores range between 1 and 6 (higher scores indicate higher satisfaction).
Measured: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Qualitative Satisfaction Data From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
A single qualitative item (i.e., What are two reasons for your rating of the overall quality of the treatment received?) was included at the end of the Overall Provider Quality subscale of the TOP Satisfaction Scale.
Measured: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Legal guardians of participants indicated "All" to "None of the Time" for each item for their child on a 6-point Likert scale.
The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
Measured: Study intervention endpoint (discharge or 6 months)
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package at Post-discharge Follow-up
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Legal guardians of participants indicated "All" to "None of the Time" for each item for their child on a 6-point Likert scale.
The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
Measured: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
Satisfaction Score From Legal Guardian Report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
The Overall Provider Quality subscale of the TOP Satisfaction Scale assesses patient satisfaction with behavioral health care. It includes 4 Likert scale items about satisfaction with treatment. Scores range between 1 and 6 (higher scores indicate higher satisfaction).
Measured: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Qualitative Satisfaction Data From Legal Guardian Ratings on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
A single qualitative item (i.e., What are two reasons for your rating of the overall quality of the treatment received?) was included at the end of the Overall Provider Quality subscale of the TOP Satisfaction Scale.
Measured: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Z Scores for Individual Domains From Participant Self Report on the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale that assesses the client's past 2-week experience on 12 domains. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale.
Only results for the CONDUCT PROBLEMS domain are presented in the Baseline Characteristics section and below because PRTF scores were significantly improved compared to Child ACTT for this one domain. All other domains (Attention Problems, Depression, Mania, Social Conflict, Worrisome Sexual Behavior, Poor School Functioning, Violence, Substance Abuse, Suicidality, Sleep Problems, Psychosis) showed no significant treatment differences at endpoint after controlling for baseline scores and individual trajectories.
Z-scores for the Conduct Problems domain range from -0.20 to 27.01. A z-score of 2 or more standard deviations from 0 (the general population mean) is considered a moderately severe score.
Measured: Study intervention endpoint (discharge or 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start4 Jan 2022
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adolescent Well-BeingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Outcome Referrals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Duke Endowment, Children's Hope Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498427
- Sponsor's protocol ID
- WCG IRB Protocol #20211997
- Status last verified
- May 2026
- First submitted
- 25 Jun 2024
- Last updated
- 2 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kraus DR, Seligman DA, Jordan JR. Validation of a behavioral health treatment outcome and assessment tool designed for naturalistic settings: The Treatment Outcome Package. J Clin Psychol. 2005 Mar;61(3):285-314. doi: 10.1002/jclp.20084.
PubMed 15546147Baxter EE, Alexander PC, Kraus DR, Bentley JH, Boswell JF, Castonguay LG. Concurrent validation of the child and adolescent versions of the Treatment Outcome Package (TOP). Journal of Child and Family Studies. 2016; 25(8): 2415-2422.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-experimental Longitudinal Study of Adolescents' Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility (PRTF)
- ClinicalTrials.gov ID
- NCT06498427
- Acronym / sponsor ID
- WCG IRB Protocol #20211997
- Conditions
- Adolescent Well-Being, Mental Disorders, Severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Outcome Referrals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Duke Endowment, Children's Hope Alliance
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Posted 2 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a quasi-experimental longitudinal study to compare the outcomes of youth in a Psychiatric Residential Treatment Facility (PRTF) compared to youth in the community-based Child-Focused Assertive Community Treatment Team [Child ACTT] program. The hypothesis is that Child ACTT will be associated with better outcomes and lower cost than PRTF among adolescents admitted to Child ACTT or PRTF.
Detailed description
Psychiatric Residential Treatment Facility (PRTF) care is expensive, removes adolescents from their communities, and is not necessarily effective. Managed care organizations (MCO) are exploring other methods of providing intensive care at home. Several states (e.g., Maine, Minnesota, Florida) have initiated and maintained Youth -Assertiveness Community Treatment (ACT) programs that are adapted from the evidence-based adult ACT model. Children's Hope Alliance (CHA) has been offering the Child-Focused Assertive Community Treatment Team [Child ACTT] Program as a service for potential clients since December 2019.
RECRUITMENT PROCEDURES
- The MCO will send a letter to PRTF treatment providers to inform them about this study.
- CHA and the PRTFs will inform the legal guardians of children who meet the inclusion criteria about a potential study opportunity.
- If the legal guardian verbally consents to being contacted by Outcome Referrals, Inc. (ORI) about the study, CHA or PRTF will forward the contact information for the legal guardian of the eligible participant to ORI via an encrypted email.
- ORI will contact the legal guardian to describe the study and review the eligibility criteria with potential participants (within 5 days of treatment authorization).
Individuals who meet the eligibility criteria and are interested in participating in the study will be sent electronic copies of the assent and consent forms to review and sign. ORI will inform the original referral source (CHA or specific PRTF) if the family is not able to be contacted or does not consent for study.
METHODS AND PROCEDURES
A randomized controlled trial was originally selected as the study design for this project because it is the gold standard for testing for causality; however, given recruitment issues, it was decided to transition to a quasi-experimental study instead. Although the investigators cannot conclude that one treatment is more efficacious than another, this quasi-experimental longitudinal study will provide important comparative information about these two treatment options for high need youth and families.
After study assent and consent forms are received by ORI, ORI will inform the referral source (CHA or PRTF) that the family consented to participate in the study: CHA or the PRTF will provide ORI with the contact information for the case manager at the facility for each participant. ORI will send an email to the case manager to inform them of that client's participation and request a time to train them on study assessment procedures.
ORI will administer a) the electronic assents and consents through an e-signature platform, and b) study assessments to both participants and their legal guardians during and post-treatment through ORI's secure platform, WellnessCheck.net.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child ACTT - Experimental | – | –Excerpt from the Partners Child ACTT service definition in North Carolina (Revised 5-23-19): Program Requirements: Child ACTT (Assertive Community Treatment Team) is a team-based multi-disciplinary approach to serve children in their homes, kinships placements, foster homes ... The team will have daily meetings to prioritize activities, share information, and discuss individual members. The team will be available to respond 24/7 for crisis de-escalation and assessment, inclusive of availability by phone within 15 minutes and face to face within no more than 2 hours. This will include face-to-face assessment by a clinician, or nurse if this is determined to be needed for the individual. The psychiatric provider will be available minimally by phone 24/7 for consultation and treatment recommendations. The team will assess the overall needs of the family to ensure that all necessary treatment and supports are in place for entire family system. |
| PRTF - Treatment as Usual | – | –Psychiatric Residential Treatment Facilities (PRTFs) are non-hospital facilities intended to provide inpatient services to Medicaid-eligible individuals who are under the age of 21. A PRTF's mission is to either improve residents' condition or prevent further regression to ultimately remove the need for such services. PRTFs provide a range of comprehensive services intended to treat residents' psychiatric conditions under the supervision and direction of a psychiatrist. The core components in a PRTF program include at least weekly medication management, 24 hours nursing services, high staff-to-client ratio with awake staff during night hours, individual, group, and family therapy, intensive psychoeducation, behavioral model of care designed to teach new functional skills, and comprehensive assessments as needed. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited from PRTF and Child ACTT. For example, the MCO reported these data from 2020: 131 unique members were served in PRTFs. Their summary demographic characteristics for gender, race, and age were as follows: 43.5 percent female and 55.7 percent male; 18 percent Black, 78 percent White, 3 percent Other and an average age of 14.5 years. Potential primary diagnoses expected are major depressive disorders, psychotic disorders, anxiety disorders, disruptive behavior disorders and bipolar disorder.
Key inclusion criteria (6 listed)
- Between the ages 12 and 18
- Has primary mental health diagnosis
- Admitted for treatment in a participating program (i.e., Psychiatric Residential Treatment Facility (PRTF) or Child ACTT)
- A trained ORI staff member determines that the youth is able to understand and sign an assent for participation
- Documentation of the youth's assent to participate in the study
Key exclusion criteria (3 listed)
- The client is not admitted to treatment in a participating program
- The client has dropped out of this study during a previous treatment episode
- Client does not initiate treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time frame: Study intervention endpoint (discharge or 6 months)
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Post-discharge Follow-up
Time frame: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
TOP is a comprehensive well-being assessment that is used in behavioral health and child welfare settings. The Adolescent TOP Clinical Scale (TOP-CS) is a 58-item scale for adolescents who are between the ages of 11 - 21. The TOP-CS assesses the client's past 2-week experience on 12 domains including Depression, Attention Problems, Conduct Problems, and Suicidality. Participants indicate "All" to "None of the Time" for each item on a 6-point Likert scale. The z-scores for each domain were averaged together to create one summary z-score. Summary z-scores range from -0.62 to 11.30 (0 = the general population mean). A higher average domain score suggests higher severity/lower behavioral health well-being.
7 secondary outcomes
Satisfaction Score From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Qualitative Satisfaction Data From Participant Self-report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time frame: Study intervention endpoint (discharge or 6 months)
Average Z-score From Legal Guardian Ratings on Domains in the Clinical Scale of the Treatment Outcome Package at Post-discharge Follow-up
Time frame: Completed follow-up within 28 days to 6 months from discharge date during 6- month study intervention
Satisfaction Score From Legal Guardian Report on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Qualitative Satisfaction Data From Legal Guardian Ratings on the Overall Provider Quality Subscale of the TOP Satisfaction Scale
Time frame: At intervention discharge (up to Month 6) or at Month 6 (study intervention endpoint)
Z Scores for Individual Domains From Participant Self Report on the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint
Time frame: Study intervention endpoint (discharge or 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15546147Kraus DR, Seligman DA, Jordan JR. Validation of a behavioral health treatment outcome and assessment tool designed for naturalistic settings: The Treatment Outcome Package. J Clin Psychol. 2005 Mar;61(3):285-314. doi: 10.1002/jclp.20084.
- BackgroundBaxter EE, Alexander PC, Kraus DR, Bentley JH, Boswell JF, Castonguay LG. Concurrent validation of the child and adolescent versions of the Treatment Outcome Package (TOP). Journal of Child and Family Studies. 2016; 25(8): 2415-2422.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Well-Being and Mental Disorders, Severe, run by Outcome Referrals, Inc. 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 6 inclusion and 3 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 2 Jun 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?
Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Z-score From Participant Self Report on Domains in the Clinical Scale of the Treatment Outcome Package (TOP-CS) at Study Intervention Endpoint (time frame: Study intervention endpoint (discharge or 6 months)). The study lists 2 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 NCT06498427, 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 2 Jun 2026.