Trial Outcomes & Findings for Novel Methods for Implementing Measurement-Based Care for Youth in Low-resource Environments (NCT NCT05644756)
NCT ID: NCT05644756
Last Updated: 2025-07-02
Results Overview
Aim 2 Therapists will report on the number of clinical outcome questionnaires administered to youth clients (the total number of outcome questionnaires per client used) before and after engaging in our researcher-driven implementation process.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
We will assess at 6 (pre-implementation), 9 (3 months post-implementation), and 12 (6 months post-implementation) months after enrollment.
Results posted on
2025-07-02
Participant Flow
Recruitment occurred at 3 distinct time points: October-November of 2022, June of 2022, and October of 2023. All recruitment was done in community mental health clinics.
For the first aim of the study (co-developing implementation plans), any member of participating community mental health center were invited to participate. After that, only therapists who served youth clients were included for the outcome data because they needed to be able to report on their use of outcome measures with youth clients. One clinic that enrolled clinic members later decided that they could not continue with the study, citing high waitlists and competing organizational priorities.
Participant milestones
| Measure |
Measurement Based Care Implementation
Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We created implementation plans to improve therapists' use of measurement-based care.
IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II): IMPACT Center developed two methods for identifying determinants that involved providers, staff, and youth at community mental health centers in site visit 1: Rapid Ethnographic Assessment, Design Probes. Then, practice partners engage in a facilitated group activity to rate the criticality, chronicity, and ubiquity of the list of determinants in Site Visit 2. Finally, practice partners engage in a third site visit where they create Causal Pathway Diagrams that allow them to match strategies to prioritize determinants and create Implementation Plans.
For aim 2, we evaluated whether the implementation plans had any effect on therapist's use of outcome questionnaires with their youth clients.
|
|---|---|
|
Aim 1 Activities (Ethnography)
STARTED
|
76
|
|
Aim 1 Activities (Ethnography)
COMPLETED
|
75
|
|
Aim 1 Activities (Ethnography)
NOT COMPLETED
|
1
|
|
Aim 2 Activities (Fidelity to MBC)
STARTED
|
35
|
|
Aim 2 Activities (Fidelity to MBC)
COMPLETED
|
30
|
|
Aim 2 Activities (Fidelity to MBC)
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Measurement Based Care Implementation
Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We created implementation plans to improve therapists' use of measurement-based care.
IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II): IMPACT Center developed two methods for identifying determinants that involved providers, staff, and youth at community mental health centers in site visit 1: Rapid Ethnographic Assessment, Design Probes. Then, practice partners engage in a facilitated group activity to rate the criticality, chronicity, and ubiquity of the list of determinants in Site Visit 2. Finally, practice partners engage in a third site visit where they create Causal Pathway Diagrams that allow them to match strategies to prioritize determinants and create Implementation Plans.
For aim 2, we evaluated whether the implementation plans had any effect on therapist's use of outcome questionnaires with their youth clients.
|
|---|---|
|
Aim 1 Activities (Ethnography)
Withdrawal by Subject
|
1
|
|
Aim 2 Activities (Fidelity to MBC)
Lost to Follow-up
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Measurement Based Care Implementation
n=30 Participants
Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We co-created implementation plans to improve therapists' use of measurement-based care by (1) identifying barriers and facilitators to MBC, (2) prioritizing barriers, and (3) co-developing an implementation strategy. The primary outcome of interest was whether the co-developed implementation strategies improved clinician's use of MBC (defined as % of youth clients administered measures) with youth clients.
NOTE: Patients/clients were not enrolled in outcome measurement, as the study was primarily focused on whether implementation strategies improved clinicians use of measurement-based care (i.e., clinicians were the primary unit of analysis).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: We will assess at 6 (pre-implementation), 9 (3 months post-implementation), and 12 (6 months post-implementation) months after enrollment.Aim 2 Therapists will report on the number of clinical outcome questionnaires administered to youth clients (the total number of outcome questionnaires per client used) before and after engaging in our researcher-driven implementation process.
Outcome measures
| Measure |
Measurement Based Care Implementation
n=30 Participants
Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We created implementation plans to improve therapists' use of measurement-based care.
IMPACT Methods to Identify and Prioritize Determinants (Challenge I), Challenge and Match strategies to Prioritized Determinants (Challenge II): IMPACT Center developed two methods for identifying determinants that involved providers, staff, and youth at community mental health centers in site visit 1: Rapid Ethnographic Assessment, Design Probes. Then, practice partners engage in a facilitated group activity to rate the criticality, chronicity, and ubiquity of the list of determinants in Site Visit 2. Finally, practice partners engage in a third site visit where they create Causal Pathway Diagrams that allow them to match strategies to prioritize determinants and create Implementation Plans.
For aim 2, we evaluated whether the implementation plans had any effect on therapist's use of outcome questionnaires with their youth clients.
|
|---|---|
|
Number of Youth Clients Provided Outcome Questionnaires
Time 1 (pre-implementation)
|
15.5 number of youth clients given measures
Standard Deviation 14.7
|
|
Number of Youth Clients Provided Outcome Questionnaires
Time 2 (3 months after implementation)
|
16.7 number of youth clients given measures
Standard Deviation 16.1
|
|
Number of Youth Clients Provided Outcome Questionnaires
Time 3 (6 months after implementation)
|
16.8 number of youth clients given measures
Standard Deviation 15.8
|
Adverse Events
Measurement Based Care Implementation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place