Trial Outcomes & Findings for Improving Student Mental Health: Adaptive School-based Implementation of CBT (NCT NCT03541317)

Last Updated: 2022-06-22

Results Overview

School professionals include counselors, social workers, and trained mental health providers working within the school. The primary aim is a comparison of schools offered the REP only intervention (the least intensive strategy) versus schools offered the adaptive implementation strategy involving REP, Coaching, and Facilitation (the most intensive strategy).

Recruitment status

COMPLETED

Study phase

Target enrollment

1329 participants

Primary outcome timeframe

Baseline to 18-months

Results posted on

2022-06-22

Participant Flow

Of the 1329 consented, listed in registration: there were 103 School administrators (for 94 schools), 978 Students were enrolled into the study, 227 school professionals from 115 schools were enrolled/consented; 21 coaches were also consented. Because primary and secondary outcome measures are all based on data collected from school professionals, only they are included in participant flow, baseline characteristics, outcome measures.

Pre-randomization, 21 schools and a total of 58 school professionals declined or did not meet eligibility and were dropped. Stage 1 Randomization: 94 schools (employing 169 school professionals (SPs)) were enrolled in the sequentially-randomized trial. Stage 2 Randomization: All 83 schools (employing 154 SPs) identified as potentially benefitting from augmentation with Facilitation (i.e., "schools that did not respond sufficiently following Stage 1 strategy") were re-randomized at Stage 2.

Unit of analysis: Schools

Participant milestones

Participant milestones
Measure	REP Only, Responders, Continue This group included schools who responded sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2.	REP Only, Non-responders, Continue This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2.	REP Only, Non-responders, Facilitation This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Augment "REP" with "Facilitation" in Stage 2.	REP + Coaching, Responders, Continue This group included schools who responded sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2.	REP + Coaching, Non-responders, Continue This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2.	REP + Coaching, Non-responders, Facilitation This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Augment "REP + Coaching" with "Facilitation" in Stage 2.
Stage 1 of the Implementation STARTED	6 5	37 21	38 21	9 6	43 21	36 20
Stage 1 of the Implementation COMPLETED	6 5	37 21	38 21	9 6	43 21	36 20
Stage 1 of the Implementation NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0
Stage 2 of the Implementation STARTED	6 5	37 21	38 21	9 6	43 21	36 20
Stage 2 of the Implementation COMPLETED	5 5	37 21	38 21	9 6	43 21	36 20
Stage 2 of the Implementation NOT COMPLETED	1 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	REP Only, Responders, Continue This group included schools who responded sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2.	REP Only, Non-responders, Continue This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Continue "REP only" in Stage 2.	REP Only, Non-responders, Facilitation This group included schools who did not respond sufficiently to "REP only" in Stage 1, and then were assigned to Augment "REP" with "Facilitation" in Stage 2.	REP + Coaching, Responders, Continue This group included schools who responded sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2.	REP + Coaching, Non-responders, Continue This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Continue "REP + Coaching" in Stage 2.	REP + Coaching, Non-responders, Facilitation This group included schools who did not respond sufficiently to "REP + Coaching" in Stage 1, and then were assigned to Augment "REP + Coaching" with "Facilitation" in Stage 2.
Stage 2 of the Implementation Withdrawal by Subject	1	0	0	0	0	0

Baseline Characteristics

This baseline characteristic applies to school units rather than to school professionals. All participating schools are included in the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1 Strategy: REP: n=47 schools Stage 1 Strategy: REP. This includes all three arms listed in Participant Flow as not receiving Coaching	Stage 1 Strategy: REP + Coaching n=47 schools Stage 1 Strategy: REP + Coaching This includes all three arms listed in Participant Flow as receiving Coaching.	Total n=94 schools Total of all reporting groups
Age, Customized > 18 years of age	81 Participants n=81 Participants	88 Participants n=88 Participants	169 Participants n=169 Participants
Sex/Gender, Customized Female	69 Participants n=81 Participants	74 Participants n=88 Participants	143 Participants n=169 Participants
Sex/Gender, Customized Male	8 Participants n=81 Participants	12 Participants n=88 Participants	20 Participants n=169 Participants
Sex/Gender, Customized Unknown	4 Participants n=81 Participants	2 Participants n=88 Participants	6 Participants n=169 Participants
Race/Ethnicity, Customized white	71 Participants n=81 Participants	80 Participants n=88 Participants	151 Participants n=169 Participants
Race/Ethnicity, Customized non-white	5 Participants n=81 Participants	6 Participants n=88 Participants	11 Participants n=169 Participants
Race/Ethnicity, Customized unknown	5 Participants n=81 Participants	2 Participants n=88 Participants	7 Participants n=169 Participants
Rural schools (vs urban) (Binary proportion)	.55 proportion STANDARD_DEVIATION .50 • n=47 schools • This baseline characteristic applies to school units rather than to school professionals. All participating schools are included in the analysis.	.57 proportion STANDARD_DEVIATION .50 • n=47 schools • This baseline characteristic applies to school units rather than to school professionals. All participating schools are included in the analysis.	.56 proportion STANDARD_DEVIATION .50 • n=94 schools • This baseline characteristic applies to school units rather than to school professionals. All participating schools are included in the analysis.
Schools with > 500 students (vs. ≤ 500 students), Binary Proportion	0.66 proportion STANDARD_DEVIATION 0.48 • n=47 schools • As this baseline characteristic applies to schools, not to the school professionals who participated in the study, number of schools analyzed is shown. All schools are included.	0.64 proportion STANDARD_DEVIATION 0.49 • n=47 schools • As this baseline characteristic applies to schools, not to the school professionals who participated in the study, number of schools analyzed is shown. All schools are included.	0.65 proportion STANDARD_DEVIATION 0.48 • n=94 schools • As this baseline characteristic applies to schools, not to the school professionals who participated in the study, number of schools analyzed is shown. All schools are included.
Schools with ≥ 50% of students on free/reduced cost lunch	0.36 proportion STANDARD_DEVIATION 0.49 • n=47 schools	.36 proportion STANDARD_DEVIATION .49 • n=47 schools	.36 proportion STANDARD_DEVIATION .48 • n=94 schools
School level average School Professional tenure	7.34 years STANDARD_DEVIATION 6.03 • n=47 schools	7.79 years STANDARD_DEVIATION 5.94 • n=47 schools	7.56 years STANDARD_DEVIATION 5.96 • n=94 schools
School level Proportion of School Professionals with graduate degree	.89 Proportion STANDARD_DEVIATION .28 • n=47 schools	.91 Proportion STANDARD_DEVIATION .24 • n=47 schools	.90 Proportion STANDARD_DEVIATION .26 • n=94 schools

PRIMARY outcome

Timeframe: Baseline to 18-months

Population: The primary outcome measure pertains to delivery of CBT by school professionals only, and thus the number analyzed reflects data categorized by number of school professionals that had REP only vs. most intensive intervention: REP, Coaching and Facilitation

Outcome measures

Outcome measures
Measure	Group 1: REP Only n=26 schools This arm consists of only those professionals in schools that received REP only: including those who were originally randomized to receive REP only and never re-randomized to receive facilitation ("responders" to REP) and those who were "non-responders to REP" but randomized to continue with REP only in Stage 2. Thus, it corresponds in Participant Flow to both the REP only, Responders Continue and REP Only, Non-Responders Continue. The 43 professionals represent 26 schools.	Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation n=26 schools This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive "Facilitation" in Stage 2. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator. Thus, this arm represents "REP + Coaching Responders, Continue" and "REP + Coaching, Non-Responders, Facilitation" from the Participant Flow. The 45 professionals represent 26 schools.
Number of CBT Sessions Delivered by School Professionals to Students After 18 Months	121.1 number of CBT sessions Interval 87.52 to 154.65	111.4 number of CBT sessions Interval 86.63 to 136.16

SECONDARY outcome

Timeframe: 18 months

The sum of the average number of brief individual CBT sessions (\<15 min.) delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2.

Outcome measures

Outcome measures
Measure	Group 1: REP Only n=26 schools This arm consists of only those professionals in schools that received REP only: including those who were originally randomized to receive REP only and never re-randomized to receive facilitation ("responders" to REP) and those who were "non-responders to REP" but randomized to continue with REP only in Stage 2. Thus, it corresponds in Participant Flow to both the REP only, Responders Continue and REP Only, Non-Responders Continue. The 43 professionals represent 26 schools.	Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation n=26 schools This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive "Facilitation" in Stage 2. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator. Thus, this arm represents "REP + Coaching Responders, Continue" and "REP + Coaching, Non-Responders, Facilitation" from the Participant Flow. The 45 professionals represent 26 schools.
Number of Brief Individual CBT Sessions	55.9 Number of brief sessions Interval 39.58 to 72.21	52.1 Number of brief sessions Interval 38.56 to 65.67

SECONDARY outcome

Timeframe: 18 Months

The sum of the average number of full individual CBT sessions (≥15 min.) delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2.

Outcome measures

Outcome measures
Measure	Group 1: REP Only n=26 schools This arm consists of only those professionals in schools that received REP only: including those who were originally randomized to receive REP only and never re-randomized to receive facilitation ("responders" to REP) and those who were "non-responders to REP" but randomized to continue with REP only in Stage 2. Thus, it corresponds in Participant Flow to both the REP only, Responders Continue and REP Only, Non-Responders Continue. The 43 professionals represent 26 schools.	Group 2: REP + Coaching, Responders Continue and REP + Coaching With Facilitation n=26 schools This arm consists of those schools that received REP + Coaching in Stage 1, who were either Responders after Stage 1 or, as Non-Responders were randomized to additionally receive "Facilitation" in Stage 2. A full-time Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools supported school professionals in strategic thinking and leadership skills to address organizational barriers. Sites receiving Facilitation received regular calls for a minimum of 10 weeks from the Facilitator. Thus, this arm represents "REP + Coaching Responders, Continue" and "REP + Coaching, Non-Responders, Facilitation" from the Participant Flow. The 45 professionals represent 26 schools.
Number of Full Individual CBT Sessions	49.5 full sessions Interval 32.77 to 66.23	41.7 full sessions Interval 29.07 to 54.23

SECONDARY outcome

Timeframe: 18 Months

The sum of the average number of group CBT sessions delivered to students by SPs over all four post-randomization phases occurring during Stages 1 and 2.