Trial Outcomes & Findings for Supporting Refugee and Immigrant Youth's Mental Health (NCT NCT05208359)
NCT ID: NCT05208359
Last Updated: 2025-07-11
Results Overview
The Stress and Difficulties Questionnaire is a 25-item (e.g., "I worry a lot") questionnaire with four subscales: emotional symptoms, conduct problems, hyperactivity/inattention problems, and peer problems. Participants answer on a 3-point Likert scale (0 = "Not at All" to 2 = "Certainly True"). Externalizing Problems are the sum of the conduct problems and hyperactivity scales. Internalizing Problems are the sum of emotional symptoms and peer problems. Scales mean range from 0 to 20 total points, with higher scores reflecting more problems (e.g., worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Baseline, 3 months, and 6 months
Results posted on
2025-07-11
Participant Flow
Eligible newcomer students were identified by school staff (teachers, school-based clinicians) across 6 participating schools.
Of the 84 identified students, 64 students were assigned to treatment groups. Students not assigned to either treatment groups declined consent, moved schools, or could not be reached.
Unit of analysis: groups
Participant milestones
| Measure |
STRONG Immediate Group
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
Overall Study
STARTED
|
32 6
|
32 6
|
|
Overall Study
COMPLETED
|
32 6
|
32 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Supporting Refugee and Immigrant Youth's Mental Health
Baseline characteristics by cohort
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.13 years
STANDARD_DEVIATION 3.17 • n=5 Participants
|
14.66 years
STANDARD_DEVIATION 2.90 • n=7 Participants
|
13.89 years
STANDARD_DEVIATION 3.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latiné/Hispanic
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MENA
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Strengths and Difficulties Questionnaire
Internalizing Problems (self-report)
|
4.70 units on a scale
STANDARD_DEVIATION 2.73 • n=5 Participants
|
3.71 units on a scale
STANDARD_DEVIATION 2.92 • n=7 Participants
|
4.20 units on a scale
STANDARD_DEVIATION 2.85 • n=5 Participants
|
|
Strengths and Difficulties Questionnaire
Internalizing Problems (teacher-report)
|
2.46 units on a scale
STANDARD_DEVIATION 2.08 • n=5 Participants
|
1.84 units on a scale
STANDARD_DEVIATION 1.65 • n=7 Participants
|
2.15 units on a scale
STANDARD_DEVIATION 1.89 • n=5 Participants
|
|
Strengths and Difficulties Questionnaire
Externalizing Problems (self-report)
|
6.34 units on a scale
STANDARD_DEVIATION 4.02 • n=5 Participants
|
5.40 units on a scale
STANDARD_DEVIATION 3.13 • n=7 Participants
|
5.87 units on a scale
STANDARD_DEVIATION 3.60 • n=5 Participants
|
|
Strengths and Difficulties Questionnaire
Externalizing Problems (teacher-report)
|
4.27 units on a scale
STANDARD_DEVIATION 4.07 • n=5 Participants
|
4.58 units on a scale
STANDARD_DEVIATION 4.21 • n=7 Participants
|
4.43 units on a scale
STANDARD_DEVIATION 4.11 • n=5 Participants
|
|
Connor-Davidson Resilience Scale
|
69.62 units on a scale
STANDARD_DEVIATION 12.03 • n=5 Participants
|
67.24 units on a scale
STANDARD_DEVIATION 16.02 • n=7 Participants
|
68.43 units on a scale
STANDARD_DEVIATION 14.11 • n=5 Participants
|
|
The Coping Efficacy Scale
Self-report
|
3.12 units on a scale
STANDARD_DEVIATION 0.51 • n=5 Participants
|
2.96 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
3.04 units on a scale
STANDARD_DEVIATION 0.60 • n=5 Participants
|
|
The Coping Efficacy Scale
Caregiver-report
|
3.21 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
3.13 units on a scale
STANDARD_DEVIATION 0.67 • n=7 Participants
|
3.17 units on a scale
STANDARD_DEVIATION 0.71 • n=5 Participants
|
|
Responses to Stress Questionnaire
Primary control coping
|
2.50 units on a scale
STANDARD_DEVIATION 0.47 • n=5 Participants
|
2.46 units on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 0.58 • n=5 Participants
|
|
Responses to Stress Questionnaire
Secondary control coping
|
2.66 units on a scale
STANDARD_DEVIATION 0.63 • n=5 Participants
|
2.63 units on a scale
STANDARD_DEVIATION 0.55 • n=7 Participants
|
2.65 units on a scale
STANDARD_DEVIATION 0.59 • n=5 Participants
|
|
Responses to Stress Questionnaire
Disengagement coping
|
2.14 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
2.22 units on a scale
STANDARD_DEVIATION 0.66 • n=7 Participants
|
2.18 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
|
School Connectedness Scale
|
4.26 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
4.07 units on a scale
STANDARD_DEVIATION 0.75 • n=7 Participants
|
4.16 units on a scale
STANDARD_DEVIATION 0.78 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, and 6 monthsThe Stress and Difficulties Questionnaire is a 25-item (e.g., "I worry a lot") questionnaire with four subscales: emotional symptoms, conduct problems, hyperactivity/inattention problems, and peer problems. Participants answer on a 3-point Likert scale (0 = "Not at All" to 2 = "Certainly True"). Externalizing Problems are the sum of the conduct problems and hyperactivity scales. Internalizing Problems are the sum of emotional symptoms and peer problems. Scales mean range from 0 to 20 total points, with higher scores reflecting more problems (e.g., worse outcome).
Outcome measures
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
Strengths and Difficulties Questionnaire
Self-reported internalizing (3 months)
|
4.91 units on a scale
Standard Deviation 2.42
|
3.49 units on a scale
Standard Deviation 2.49
|
|
Strengths and Difficulties Questionnaire
Teacher-reported internalizing (3 months)
|
2.72 units on a scale
Standard Deviation 2.71
|
2.72 units on a scale
Standard Deviation 2.53
|
|
Strengths and Difficulties Questionnaire
Self-reported internalizing (6 months)
|
4.05 units on a scale
Standard Deviation 2.26
|
3.09 units on a scale
Standard Deviation 2.23
|
|
Strengths and Difficulties Questionnaire
Teacher-reported internalizing (6 months)
|
2.40 units on a scale
Standard Deviation 2.50
|
2.40 units on a scale
Standard Deviation 2.06
|
|
Strengths and Difficulties Questionnaire
Self-reported externalizing (3 months)
|
5.85 units on a scale
Standard Deviation 3.71
|
6.20 units on a scale
Standard Deviation 3.24
|
|
Strengths and Difficulties Questionnaire
Teacher-reported externalizing (3 months)
|
3.75 units on a scale
Standard Deviation 4.31
|
5.65 units on a scale
Standard Deviation 4.50
|
|
Strengths and Difficulties Questionnaire
Self-reported externalizing (6 months)
|
5.40 units on a scale
Standard Deviation 3.53
|
5.07 units on a scale
Standard Deviation 2.90
|
|
Strengths and Difficulties Questionnaire
Teacher-reported externalizing (6 months)
|
4.23 units on a scale
Standard Deviation 4.45
|
5.41 units on a scale
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsConnor-Davidson Resilience Scale is a 25-item measures that measures adaptability and resilience among youth. Participants rated each item on a 5-point Likert scale (0= "Not True at All" to 4 = "True Nearly All of Time"). Total scores range from 0 to 100, with higher scores indicating more adaptability and resilience (e.g., better outcome).
Outcome measures
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
Connor-Davidson Resilience Scale
3 months
|
75.68 units on a scale
Standard Deviation 16.46
|
72.08 units on a scale
Standard Deviation 14.54
|
|
Connor-Davidson Resilience Scale
6 months
|
74 units on a scale
Standard Deviation 15.15
|
75.27 units on a scale
Standard Deviation 11.65
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsThe Coping Efficacy Scale (Sandler et al., 2000) measures an individual's belief in their ability to use coping strategies to handle future stressors and novel situations. For this study, six items designed to assess both satisfaction with past coping efforts and anticipated effectiveness in handling future problems were included. The scale uses a 4-point scale (1= "Not At All" to 4 = "Well"), with higher scores indicating greater coping efficacy (e.g., better outcome).
Outcome measures
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
The Coping Efficacy Scale
Self-reported (3 months)
|
2.98 units on a scale
Standard Deviation 0.55
|
3.09 units on a scale
Standard Deviation 0.53
|
|
The Coping Efficacy Scale
Caregiver-reported (3 months)
|
3.30 units on a scale
Standard Deviation 0.51
|
3.14 units on a scale
Standard Deviation 0.82
|
|
The Coping Efficacy Scale
Self-reported (6 months)
|
3.05 units on a scale
Standard Deviation 0.58
|
3.10 units on a scale
Standard Deviation 0.60
|
|
The Coping Efficacy Scale
Caregiver-reported (6 months)
|
3.44 units on a scale
Standard Deviation 0.55
|
3.12 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsThe Responses to Stress Questionnaire (RSQ) is a 57-item multidimensional measure on 4-point Likert scale (1= "Not at all" to 4 = "A lot"). Primary control, secondary control, and disengagement coping factors were used in this study. With higher mean scores reporting higher coping in each respective factor. Mean scores were used.
Outcome measures
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
Responses to Stress Questionnaire
Secondary coping (6 months)
|
2.66 units on a scale
Standard Deviation 0.52
|
2.62 units on a scale
Standard Deviation 0.55
|
|
Responses to Stress Questionnaire
Primary coping (3 months)
|
2.63 units on a scale
Standard Deviation 0.67
|
2.47 units on a scale
Standard Deviation 0.62
|
|
Responses to Stress Questionnaire
Secondary coping (3 months)
|
2.70 units on a scale
Standard Deviation 0.46
|
2.67 units on a scale
Standard Deviation 0.63
|
|
Responses to Stress Questionnaire
Disengagement coping (3 months)
|
2.08 units on a scale
Standard Deviation 0.67
|
2.08 units on a scale
Standard Deviation 0.67
|
|
Responses to Stress Questionnaire
Primary coping (6 months)
|
2.82 units on a scale
Standard Deviation 0.57
|
2.60 units on a scale
Standard Deviation 0.66
|
|
Responses to Stress Questionnaire
Disengagement coping (6 months)
|
2.01 units on a scale
Standard Deviation 0.64
|
2.09 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsThe School Connectedness Scale is a 5-item questionnaire that measures youth's bond toward their school on a 5-point Likert scale (1="Strong Disagree" to 5="Strongly Agree"). Mean scores were used in analysis, with higher scores indicating higher school connectedness (e.g., better outcome).
Outcome measures
| Measure |
STRONG Immediate Group
n=32 Participants
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 Participants
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
School Connectedness Scale
3 months
|
4.27 units on a scale
Standard Deviation 0.52
|
4.11 units on a scale
Standard Deviation 0.78
|
|
School Connectedness Scale
6 months
|
4.17 units on a scale
Standard Deviation 0.75
|
4.08 units on a scale
Standard Deviation 0.86
|
Adverse Events
STRONG Immediate Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
STRONG Delayed Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
STRONG Immediate Group
n=32 participants at risk
Small mental health support group delivered immediately
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
STRONG Delayed Group
n=32 participants at risk
Small mental health support group delivered after a delay of approximately 3 months
Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth
|
|---|---|---|
|
Social circumstances
Endorsed risk and abuse
|
0.00%
0/32 • 1 year, 7 months
0 participants experiences all-cause mortality and serious adverse events. 1 participant experienced 1 other (not including serious) adverse event through self-disclosure from participant to research assistant during data collection.
|
3.1%
1/32 • Number of events 1 • 1 year, 7 months
0 participants experiences all-cause mortality and serious adverse events. 1 participant experienced 1 other (not including serious) adverse event through self-disclosure from participant to research assistant during data collection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place