Clinical trial NCT06498427: Adolescents' Well-being in Community-based Treatment Versus Residential Treatment
Official title: A Quasi-experimental Longitudinal Study of Adolescents' Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility (PRTF)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adolescent Well-Being
Mental Disorders, Severe
Lead sponsor: Outcome Referrals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Duke Endowment
name: Children's Hope Alliance
First posted: 2024-07-12
Enrollment: 210
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from PRTF and Child ACTT. For example, at Partners MCO in 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.

Brief summary: This is a quasi-experimental longitudinal study to compare the outcomes of youth in Psychiatric Residential Treatment Facility (PRTF) compared to youth in the at-home 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 ACTT 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

1. The MCO will send a letter to PRTF treatment providers to inform them about this study.
2. CHA and the PRTFs will inform the legal guardians of children who meet the inclusion criteria about a potential study opportunity.
3. 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.
4. 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change on average z-scores from participant self report on Clinical Scale of the Treatment Outcome Package (TOP-CS) over time
timeFrame: Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge.
Secondary outcomes:
measure: Satisfaction score most proximal to discharge (up to Month 6) from participant self report on the Overall Provider Quality subscale of the TOP Satisfaction Scale
timeFrame: Every month up to Month 6 during treatment
measure: Mean change on average z-scores from legal guardian ratings for the participants on the Treatment Outcome Package
timeFrame: Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge.
measure: Satisfaction score most proximal to discharge (up to Month 6) from legal guardian report on the Overall Provider Quality subscale of the TOP Satisfaction Scale
timeFrame: Every month up to Month 6 during treatment
measure: Mean change on the z-score for individual domains from participant self report on the Treatment Outcome Package
timeFrame: Baseline completed within 3 weeks of treatment start then a TOP every month up to Month 6 during treatment then at 3 months post-discharge.
Other outcomes:
measure: Cost of treatment
timeFrame: Through study treatment completion, a maximum of 6 months
Locations:
city: Framingham
country: United States
facility: Outcome Referrals, Inc.
state: Massachusetts
Study officials:
References:
citation: 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.
citation: Baxter 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.