Trial Outcomes & Findings for FMBI With War-affected Families (NCT NCT05241314)

Results Overview

Strengths and Difficulties Questionnaire (SDQ I/S). A 25-item youth behavioral screening questionnaire, Total difficulties score: generated by summing scores from all the scales except prosocial scale, Range 0-40. Higher score, higher adjustment challenges

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

3 months

Results posted on

2025-04-02

Participant Flow

Phase 1 described in the IRB protocol was for intervention adaptation only and not human subjects research. We did not record individual outcomes or baseline information but used the information to inform implementation in phase 2. This record is for phase 2 part of the study and not phase 1.

Participant milestones

Participant milestones
Measure	Caregiver Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Overall Study STARTED	14	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FMBI With War-affected Families

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Caregiver n=14 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=11 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	0 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 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	14 Participants n=5 Participants	11 Participants n=7 Participants	25 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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

PRIMARY outcome

Timeframe: 3 months

Population: This outcome measure only pertains to the youth group

Strengths and Difficulties Questionnaire (SDQ I/S). A 25-item youth behavioral screening questionnaire, Total difficulties score: generated by summing scores from all the scales except prosocial scale, Range 0-40. Higher score, higher adjustment challenges

Outcome measures

Outcome measures
Measure	Caregiver Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Youth Adjustment	—	-2.3 units on a scale Interval -8.1 to 3.5

PRIMARY outcome

Timeframe: 3 months

Population: This outcome measure only pertains to the youth group

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). A 12-item assessment of mindfulness as a single construct. Items 2, 6, and 7 reverse-scored. After reversals, sum values for items 1-12. Sum of all values reflect greater mindful qualities. The range of the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) is 12-48. It is a 12-item scale where each item is rated on a 1-4 Likert scale, with higher scores indicating greater mindfulness.

Outcome measures

Outcome measures
Measure	Caregiver Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Mindfulness	—	0.5 units on a scale Interval -0.9 to 1.9

PRIMARY outcome

Timeframe: 3 months

Population: This outcome measure only pertains to the youth group

UCLA Brief Screen for Child/Adolescent Trauma and PTSD (UCLA-B). A 11-item (+2 open ended) evaluation of trauma history and PTSD symptoms for identifying at-risk cases. A cutoff score of 35 is highly sensitive and specific for detecting a diagnosis of PTSD. Higher score, higher burden of PTSD symptoms UCLA brief trauma screen: This was a screening tool used to establish the eligibility of youth participants. This was not included in the analysis. Each item on the scale is rated on a 0-4 scale, with higher scores signifying greater symptom severity, range 0-44. The FACES instrument is not scored based on a range, as described.

Outcome measures

Outcome measures
Measure	Caregiver Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Youth Trauma History, PTSD Screening	—	0.6 units on a scale Interval -1.67 to 2.87

PRIMARY outcome

Timeframe: 3 months

Population: This outcome measure only pertains to the youth group

Emotion Regulation Skills Questionnaire (ERSQ). A 27-item assessment of emotion regulation skills described in the ART model. Calculated mean of all questions. Higher score indicates better Emotion Regulation. The Emotion Regulation Skills Questionnaire (ERSQ) is a 27 item scale that uses a 5-point Likert scale for each item, 0 (not at all) to 4 (almost always), with a total score range of 0-108.

Outcome measures

Outcome measures
Measure	Caregiver Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Emotion Regulation	—	-1.1 units on a scale Interval -3.47 to 1.27

PRIMARY outcome

Timeframe: 3 months

Population: Measure only pertains to the caregiver group

Karen Mental Health Screener - Brief (KMHS-B). 5-item measure developed to screen for mental distress associated with MDD and PTSD. Possible score ranges for five items 0-15. For clinical use, clinical cut score of 4. Higher score, higher burden of PTSD symptoms. Used cut score to refer

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Parent Mental Health Distress	0.44 units on a scale Interval -2.3 to 3.19	—

SECONDARY outcome

Timeframe: 3 months

Cohen-Hoberman Inventory of Physical Symptoms (CHIPS). A 33-item assessment of perceived burden from physical symptoms. Total score generated by summing items. Range 0-132. Higher score, higher burden of physical symptoms

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Physical Health Status	0.047 units on a scale Interval -0.139 to 0.23	0.013 units on a scale Interval -0.057 to 0.083

SECONDARY outcome

Timeframe: 3 months

Family Adaptability and Cohesion Scale IV (FACES). A 42-item assessment of cohesion and flexibility. Dividing the average of the balanced scales (Cohesion and Flexibility) by the average of the unbalanced scales (Rigid, Enmeshed, Chaotic and Rigid). The higher the ratio score the more balanced the family system. Each item on the scale is rated on a 0-4 scale, with higher scores signifying greater symptom severity, range 0-44. The FACES instrument is not scored based on a range, as described.

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Family Functioning	0.002 units on a scale Interval -0.006 to 0.009	0.003 units on a scale Interval -0.001 to 0.008

SECONDARY outcome

Timeframe: 3 months

Emotion Regulation Skills Questionnaire (ERSQ). A 27-item assessment of emotion regulation skills described in the ART model. ESRQ - 27 items, each scored 0-4, range 0-108, higher scores mean higher emotion regulation. Total scores used, no subscales. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) has a range of scores from 12 to 48, each of the 12 items is rated on a 4-point Likert scale (from "Rarely/Not at all" to "Almost Always") with higher scores indicating greater mindfulness.

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Emotion Regulation	0.062 units on a scale Interval -0.436 to 0.559	0.137 units on a scale Interval -0.428 to 0.702

SECONDARY outcome

Timeframe: 3 months

Cognitive and Affective Mindfulness Scale- Revised (CAMS-R). A 12-item assessment of mindfulness as a single construct. Items 2, 6, and 7 reverse-scored. After reversals, sum values for items 1-12. Sum of all values reflect greater mindful qualities. ESRQ - 27 items, each scored 0-4, range 0-108, higher scores mean higher emotion regulation. Total scores used, no subscales. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) has a range of scores from 12 to 48, each of the 12 items is rated on a 4-point Likert scale (from "Rarely/Not at all" to "Almost Always") with higher scores indicating greater mindfulness.

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Mindfulness	-0.08 units on a scale Interval -0.44 to 0.28	0.06 units on a scale Interval -0.31 to 0.44

SECONDARY outcome

Timeframe: 3 months

Cohen-Hoberman Inventory of Physical Symptoms (CHIPS). A 33-item assessment of perceived burden from physical symptoms. Total score generated by summing items. Range 0-132. Higher score, higher burden of physical symptoms

Outcome measures

Outcome measures
Measure	Caregiver n=9 Participants Engaged Karen refugee caregivers in 14 session mindful parenting intervention Intervention: ADAPT	Youth n=10 Participants Engaged Karen adolescent youth in 6 session mindfulness intervention Intervention: Learning to BREATHE
Physical Symptom Burden	7 units on a scale Interval -19.0 to 33.0	-3.5 units on a scale Interval -16.4 to 9.4

Adverse Events

Caregiver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Youth

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

Sarah Hoffman

University of Minnesota

Phone: 612-625-0606

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place