Trial Outcomes & Findings for Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications) (NCT NCT02714868)
NCT ID: NCT02714868
Last Updated: 2019-11-25
Results Overview
All youth had four goals in the following areas: 1) a participation goal, 2) their ability to identify environmental barriers to their goal, 3) their ability to generate solutions to barriers, and 4) their ability to advocate for needed changes to achieve their goal. Each goal used a five-point goal attainment scale with baseline at -1. Goals levels were created at intake (initial assessment). For the knowledge application goals (goal 2-4), we created standardized goal levels to ensure content validity and reliability within and across youth. Goal attainment for all four goals was rated 12 weeks following intake (outcome) and transformed into a t-score. A t-score of 50 indicates all goals were achieved at the expected level; t-scores greater than 50 indicate individuals exceeded the expected level of goal attainment. Scores range from 0-100 (100 indicates greater than expected goal attainment).
COMPLETED
NA
82 participants
12 weeks following intake (outcome)
2019-11-25
Participant Flow
Convenience sample, recruited from partnering community agencies and schools
Non- randomized assignment
Participant milestones
| Measure |
Project TEAM Intervention
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
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Matched Comparison
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
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|---|---|---|
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Overall Study
STARTED
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47
|
35
|
|
Overall Study
COMPLETED
|
42
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Project TEAM Intervention
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
PI withdrawal safety risk self/others
|
1
|
0
|
|
Overall Study
PI withdraw did not meet inclusion
|
1
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0
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Baseline Characteristics
Evaluation of Project TEAM (Teens Making Environmental and Activity Modifications)
Baseline characteristics by cohort
| Measure |
Project TEAM Intervention
n=47 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=35 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
|
Total
n=82 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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17.5 years
STANDARD_DEVIATION 1.8 • n=5 Participants
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17.42 years
STANDARD_DEVIATION 2.25 • n=7 Participants
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17.5 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
35 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Intellectual disability
No intellectual disability IQ> 69
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Intellectual disability
Mild Intellectual disability IQ 50-69
|
17 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Intellectual disability
Moderate intellectual disability IQ 35-49
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Intellectual disability
missing
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks following intake (outcome)Population: We did not score GAS for withdrawn Project TEAM participants.
All youth had four goals in the following areas: 1) a participation goal, 2) their ability to identify environmental barriers to their goal, 3) their ability to generate solutions to barriers, and 4) their ability to advocate for needed changes to achieve their goal. Each goal used a five-point goal attainment scale with baseline at -1. Goals levels were created at intake (initial assessment). For the knowledge application goals (goal 2-4), we created standardized goal levels to ensure content validity and reliability within and across youth. Goal attainment for all four goals was rated 12 weeks following intake (outcome) and transformed into a t-score. A t-score of 50 indicates all goals were achieved at the expected level; t-scores greater than 50 indicate individuals exceeded the expected level of goal attainment. Scores range from 0-100 (100 indicates greater than expected goal attainment).
Outcome measures
| Measure |
Project TEAM Intervention
n=42 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=35 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
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|---|---|---|
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Goal Attainment Scaling (GAS)
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54.58 t-score
Standard Deviation 9.69
|
44.69 t-score
Standard Deviation 10.92
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PRIMARY outcome
Timeframe: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)Population: We did not analyze 5 youth on this measure in the intervention group: 2 were withdrawn by PI, and 3 withdrew from study. An additional participant had all missing data for this measure at all time points
Part I: Knowledge of parts of the environment, modification strategies, and the "Game Plan." Higher scores indicate more correct responses. Part I responses were independently coded as correct/incorrect by the study facilitator and a trained graduate student; discrepancies were resolved by a third scorer (the PI). To establish unidimensionality, we applied a dichotomous Rasch model and removed 24% of the items with Outfit Mean Square \>2; values higher than 2 can indicate guessing. The resulting interval sum scores, in logits, were used for analysis; higher logit scores indicate more knowledge (Minimum: -4.05 to maximum 6.69). Higher scores indicate greater problem solving.
Outcome measures
| Measure |
Project TEAM Intervention
n=41 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=35 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
|
|---|---|---|
|
Project TEAM Knowledge Test
outcome (12 weeks)
|
0.45 scores on a test
Standard Deviation 1.87
|
-1.37 scores on a test
Standard Deviation .95
|
|
Project TEAM Knowledge Test
intake
|
-2.02 scores on a test
Standard Deviation .77
|
-1.5 scores on a test
Standard Deviation .86
|
|
Project TEAM Knowledge Test
6 week follow up
|
0.15 scores on a test
Standard Deviation 1.85
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-1.15 scores on a test
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)Population: Some participants (4.9%) were not attending school, and therefore did not complete questions about school. To avoid imputing data not missing at random, we dropped these participants from the analyses of the AIR which included school items.
The AIR measured the capacity and opportunity to act in a self-determined manner at home and school. Parallel youth and parent forms used a 5-point frequency scale (never-always), with higher scores reflecting more self-determination. Reported here are parent self-reported sum scores at outcome. Sum scores range from minimum 18- to maximum 90 (90/higher scores = more self determination)
Outcome measures
| Measure |
Project TEAM Intervention
n=46 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=31 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
|
|---|---|---|
|
AIR Self-Determination Scale (American Institutes on Research- AIR)
6 week follow up
|
64.26 scores on a scale
Standard Deviation 10.56
|
63.39 scores on a scale
Standard Deviation 8.14
|
|
AIR Self-Determination Scale (American Institutes on Research- AIR)
Outcome (12 weeks)
|
63.30 scores on a scale
Standard Deviation 10.30
|
62.74 scores on a scale
Standard Deviation 9.13
|
|
AIR Self-Determination Scale (American Institutes on Research- AIR)
intake
|
59.61 scores on a scale
Standard Deviation 10.16
|
60.84 scores on a scale
Standard Deviation 11.23
|
PRIMARY outcome
Timeframe: intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)Population: Some participants (4.9%) were not attending school, and therefore did not complete questions about school. To avoid imputing data not missing at random, we dropped these participants from the analyses of the GSES which included school items.
We revised a disability self-efficacy scale for this study and created additional questions to assess self-efficacy for addressing environmental barriers. We used a modified three point response scale (Not like me, Sort of like me, Really like me) that incorporated visuals to support comprehension. Higher scores indicated higher self-efficacy. Sum scores range from minimum 11 to maximum 33.
Outcome measures
| Measure |
Project TEAM Intervention
n=46 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=33 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
|
|---|---|---|
|
Generalized Self Efficacy Scale (GSES)
outcome
|
26.93 scores on a scale
Standard Deviation 4.37
|
26.73 scores on a scale
Standard Deviation 3.45
|
|
Generalized Self Efficacy Scale (GSES)
intake
|
26.41 scores on a scale
Standard Deviation 4.26
|
26.33 scores on a scale
Standard Deviation 4.38
|
|
Generalized Self Efficacy Scale (GSES)
6 week follow up
|
26.67 scores on a scale
Standard Deviation 4.10
|
26.52 scores on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: intake, 12 weeks following intake (outcome)Population: This is the number of youth who completed the community context participation frequency scores at outcome because the identified participation goal (see GAS outcome measure) occurred in the community context.
Frequency of participation in home, school, and the community. Parent report. We examined change in scores between baseline and outcome only for the context in which the individuals' goal occurred (e.g., for GAS goals regarding going to a concert, the parent only completed "community" at outcome. Higher scores indicate higher frequency of participation. Below, we only report outcomes for the youth with community data at outcome, as it was the most frequently occurring goal context . 0 is do not ever participate, and 7 is participate daily. HIgher scores indicate more frequent participation in the context
Outcome measures
| Measure |
Project TEAM Intervention
n=42 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=34 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
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|---|---|---|
|
Participation and Environment Measure for Children and Youth (PEM-CY)
|
2.67 units on a scale
Standard Deviation 1.02
|
2.35 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: intake, 12 weeks following intake (outcome)readiness to engage in advocacy based on transtheoretical model of change. This is a single question with a 5 possible responses (1= minimum, 5= maximum), where higher responses (5) indicate higher readiness for advocacy. Data is reported as increase (improvement in readiness), no change, or decrease (decline in readiness). Improvement is a better outcome. Below, reported for number of participants in each group with improvement between intake and 12 weeks following intake (outcome).
Outcome measures
| Measure |
Project TEAM Intervention
n=37 Participants
Project TEAM is a manualized intervention co- facilitated by a disability advocate and a licensed professional. The intervention includes eight group sessions and two experiential learning field trips. In addition, young adults with disabilities serve as peer mentors on field trips and contact youth weekly to support attainment of goals.
Project TEAM: Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
|
Matched Comparison
n=35 Participants
Youth with disabilities who are matched controls will receive their typical educational or therapeutic services. Youth will receive a stipend to participate in a preferred activity in the community; youth will document what they did and with whom they participated. Attempts to control for the impact of resources on participation and goal achievement.
Matched Comparison: Participants set goal to try a new activity in the community
|
|---|---|---|
|
Readiness for Advocacy
Improvement
|
16 Participants
|
10 Participants
|
|
Readiness for Advocacy
No change
|
12 Participants
|
16 Participants
|
|
Readiness for Advocacy
Decrease
|
9 Participants
|
9 Participants
|
Adverse Events
Project TEAM Intervention
Matched Comparison
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jessica Kramer, Assistant Professor, PI
Department of Occupational Therapy, Boston University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place