Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498427
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-12
First Post:
2024-06-25
Brief Title:
Adolescents Well-being in Community-based Treatment Versus Residential Treatment
Sponsor:
Outcome Referrals Inc
Organization:
Outcome Referrals Inc
Study Overview
Official Title:
A Quasi-experimental Longitudinal Study of Adolescents Well-being in Community-based Treatment Versus in a Psychiatric Residential Treatment Facility PRTF
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg Maine Minnesota Florida have initiated and maintained Youth -Assertiveness Community Treatment ACT programs that are adapted from the evidence-based adult ACTT model Childrens 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 clients 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 ORIs secure platform WellnessChecknet
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 clients 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 ORIs secure platform WellnessChecknet
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None