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Completed

NCT Number: NCT06498427

Adolescents' Well-being in Community-based Treatment Versus Residential Treatment

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.

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Key information

Conditions

Adolescent Well-Being Mental Disorders Mental Disorders, Severe

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Outcome Referrals, Inc.

Framingham, Massachusetts, 01701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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.

  3. 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)

    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.

  4. 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

    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.

  5. 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)

    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).

  6. 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)

    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.

  7. 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)

    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.

Other outcomes

  1. Cost of Treatment at Study Intervention Endpoint

    Time frame: Through study treatment completion, a maximum of 6 months

    Estimated treatment cost per condition will be assessed by calculating the number of days in treatment times cost per day

Sponsors and collaborators

Lead sponsor

Outcome Referrals, Inc.

Industry

Collaborators

  • Children's Hope Alliance
  • The Duke Endowment

Registry information

Official study title

A Quasi-experimental Longitudinal Study of Adolescents' Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility (PRTF)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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