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Middle School Success Over Stress

Supplement: Long-term Effects of the Family Check-up on Depression and Suicide Across Trials and Development

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05117099
Acronym
MSSOS
Enrollment
308
Registered
2021-11-11
Start date
2021-10-11
Completion date
2023-01-23
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Parent-Child Relations, Parenting, Self-regulation

Brief summary

It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals. In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.

Interventions

BEHAVIORALFamily Check-Up

This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered.

Sponsors

Case Western Reserve University
CollaboratorOTHER
University of Oregon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Families will be assigned to treatment vs. waitlist control. The investigators will assess families at baseline and at 2-, 4-, and 6-month follow-ups. Families in the treatment condition will receive the intervention between baseline and the 2-month follow-up.The control group will receive the intervention following the 4-month assessment.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* A caregiver must have a child between the ages of 10 and 14; * the caregiver must be the parent or legal guardian of the participating youth; * the caregiver must have a smartphone with text messaging capability and access to email; and * the caregiver must score at least 1 or above on the Patient Health Questionnaire-2, or score at least 2 on any item of the Perceived Stress Scale-4.

Exclusion criteria

* the caregiver is unable to read in either English or Spanish; * the child is unable to complete the survey without parent's help; or * the family is already participating in another study of the University of Oregon's Prevention Science Institute.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Parent Mental Health and Well-being (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Change From Baseline in Parental Stress (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their parenting stress using the Parenting Stress Index (PSI), a 14-item questionnaire. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never, almost never, sometimes, fairly often, very often). Scores ranged from 0-4. High scores indicate greater parenting stress.
Change From Baseline in Child Behavior and Emotional Problems (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). Response options for each item ranged from 0-2. Subscale totals were created by summing responses for a possible range of 0-10 for each subscale. The sums from each subscale were summed to create a composite score. High scores indicate greater conduct problems.
Change From Baseline in Youth Depression (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their child's depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their child's mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.
Change From Baseline in Parenting Skills (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their parenting skills using a version of the Parenting Young Children Questionnaire (PARYC). The PARYC version adapted for this study was a 21-item questionnaire. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 5-pt scale (never, rarely, sometimes, often, and very often). Scores for each item ranged from 0-4, and scores were averaged to create a total score. High scores indicate greater parenting skills.
Change From Baseline in Positive Family Relationships (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their family relationships using a family togetherness scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Change From Baseline in Family Conflict (Parent Report)baseline, 2 months, 4 months, 6 monthsParents reported on their family conflict using a family conflict scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores for each item ranged from 0-6, and scores were averaged to create a total score. High scores indicate increased family conflict.
Change From Baseline in Youth Depression (Child Report)baseline, 6 monthsYouth reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire modified for teen use. Youth were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores for each item ranged from 1-4, and scores were averaged to create a total score. High scores indicate greater depressive symptoms.
Change From Baseline in Positive Family Relationships (Child Report)baseline, 6 monthsYouth reported on their family relationships using a family togetherness scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.
Change From Baseline in Family Conflict (Child Report)baseline, 6 monthsYouth reported on their family conflict using a family conflict scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores ranged from 1-7. High scores indicate increased family conflict.

Countries

United States

Participant flow

Pre-assignment details

377 families inquired about study participation. Some were excluded due to being unresponsive to outreach (n=191), declining to participate (n=11), or not meeting inclusion criteria (n=14). Families who returned baseline surveys (n=161 parent/caregivers; n=147 youth) were randomly assigned to one of two conditions.

Participants by arm

ArmCount
Waitlist Control
Parents in this arm will initially serve as the control group but will receive access to the FCU Online website and telehealth coaching after completing three waves of data collection (baseline, 2-mo, and 4-mo follow-up).
166
FCU Online + Coach
Parents in this arm will receive access to the FCU Online website and telehealth coaching/ support provided by a trained mental health provider. The FCU Online website includes a brief 5-minute assessment, feedback on parents' responses, and online tools to support parenting in areas that were identified as challenges by the assessment. These tools include videos, animated videos, parenting tips, and interactives to help practice parenting skills.Telehealth coaching sessions will focus on Healthy Behaviors, Positive Parenting, Rules and Consequences, School Support, and Communication. Family Check-Up: This intervention includes access to the Family Check-Up Online website and telehealth coaching provided by trained mental health providers. A minimum of 5 coaching sessions will be offered.
142
Total308

Baseline characteristics

CharacteristicWaitlist ControlFCU Online + CoachTotal
Age, Continuous
Parent
43.6 years
STANDARD_DEVIATION 7.09
41.91 years
STANDARD_DEVIATION 5.99
42.82 years
STANDARD_DEVIATION 6.64
Age, Continuous
Youth
12.44 years
STANDARD_DEVIATION 1.04
12.57 years
STANDARD_DEVIATION 1.06
12.50 years
STANDARD_DEVIATION 1.05
Ethnicity (NIH/OMB)
Parent
Hispanic or Latino
19 Participants14 Participants33 Participants
Ethnicity (NIH/OMB)
Parent
Not Hispanic or Latino
68 Participants60 Participants128 Participants
Ethnicity (NIH/OMB)
Parent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Youth
Hispanic or Latino
14 Participants14 Participants28 Participants
Ethnicity (NIH/OMB)
Youth
Not Hispanic or Latino
64 Participants54 Participants118 Participants
Ethnicity (NIH/OMB)
Youth
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Parent
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Asian
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Parent
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Parent
More than one race
9 Participants10 Participants19 Participants
Race (NIH/OMB)
Parent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Unknown or Not Reported
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Parent
White
74 Participants62 Participants136 Participants
Race (NIH/OMB)
Youth
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Youth
Asian
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Youth
Black or African American
3 Participants2 Participants5 Participants
Race (NIH/OMB)
Youth
More than one race
9 Participants13 Participants22 Participants
Race (NIH/OMB)
Youth
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Youth
Unknown or Not Reported
7 Participants2 Participants9 Participants
Race (NIH/OMB)
Youth
White
55 Participants50 Participants105 Participants
Region of Enrollment
United States
166 participants142 participants308 participants
Sex/Gender, Customized
Parent
Female
82 Participants70 Participants152 Participants
Sex/Gender, Customized
Parent
Male
5 Participants4 Participants9 Participants
Sex/Gender, Customized
Parent
Other
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Parent
Prefer not to answer
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Youth
Female
35 Participants32 Participants67 Participants
Sex/Gender, Customized
Youth
Male
34 Participants34 Participants68 Participants
Sex/Gender, Customized
Youth
Other
7 Participants2 Participants9 Participants
Sex/Gender, Customized
Youth
Prefer not to answer
3 Participants0 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 870 / 740 / 790 / 68
other
Total, other adverse events
0 / 870 / 740 / 790 / 68
serious
Total, serious adverse events
0 / 870 / 740 / 790 / 68

Outcome results

Primary

Change From Baseline in Child Behavior and Emotional Problems (Parent Report)

Parents reported on their child's problem behavior using the Strengths and Difficulties Questionnaire (SDQ), a 25-item brief behavioral screening questionnaire that consists of 5 subscales with 5 questions each. The 5 subscales are conduct problems, emotional problems, hyperactivity, peer problems, and prosocial behavior. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 3-pt scale (not true, somewhat true, and certainly true). Response options for each item ranged from 0-2. Subscale totals were created by summing responses for a possible range of 0-10 for each subscale. The sums from each subscale were summed to create a composite score. High scores indicate greater conduct problems.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Child Behavior and Emotional Problems (Parent Report)4-month Follow-up11.6056 score on a scaleStandard Deviation 6.23465
Waitlist ControlChange From Baseline in Child Behavior and Emotional Problems (Parent Report)Baseline13.2184 score on a scaleStandard Deviation 6.4833
Waitlist ControlChange From Baseline in Child Behavior and Emotional Problems (Parent Report)6-month Follow-up11.9726 score on a scaleStandard Deviation 5.93243
Waitlist ControlChange From Baseline in Child Behavior and Emotional Problems (Parent Report)2-month Follow-up12.8630 score on a scaleStandard Deviation 6.62343
FCU Online + CoachChange From Baseline in Child Behavior and Emotional Problems (Parent Report)6-month Follow-up12.2319 score on a scaleStandard Deviation 7.5091
FCU Online + CoachChange From Baseline in Child Behavior and Emotional Problems (Parent Report)2-month Follow-up12.2143 score on a scaleStandard Deviation 6.3266
FCU Online + CoachChange From Baseline in Child Behavior and Emotional Problems (Parent Report)4-month Follow-up12.1587 score on a scaleStandard Deviation 7.17119
FCU Online + CoachChange From Baseline in Child Behavior and Emotional Problems (Parent Report)Baseline14.2568 score on a scaleStandard Deviation 7.53814
p-value: 0.915ANOVA
Primary

Change From Baseline in Family Conflict (Child Report)

Youth reported on their family conflict using a family conflict scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores ranged from 1-7. High scores indicate increased family conflict.

Time frame: baseline, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Family Conflict (Child Report)Baseline2.6184 score on a scaleStandard Deviation 1.22234
Waitlist ControlChange From Baseline in Family Conflict (Child Report)6-month Follow-up2.5323 score on a scaleStandard Deviation 1.13394
FCU Online + CoachChange From Baseline in Family Conflict (Child Report)Baseline2.8640 score on a scaleStandard Deviation 1.31043
FCU Online + CoachChange From Baseline in Family Conflict (Child Report)6-month Follow-up2.6636 score on a scaleStandard Deviation 1.08463
p-value: 0.332ANOVA
Primary

Change From Baseline in Family Conflict (Parent Report)

Parents reported on their family conflict using a family conflict scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 4 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 7-pt scale (never, once, twice, 3 times, 4 or 5 times, 6 or 7 times and more than 7 times). Scores for each item ranged from 0-6, and scores were averaged to create a total score. High scores indicate increased family conflict.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Family Conflict (Parent Report)Baseline1.8046 score on a scaleStandard Deviation 1.14908
Waitlist ControlChange From Baseline in Family Conflict (Parent Report)4-month Follow-up1.6725 score on a scaleStandard Deviation 0.96602
Waitlist ControlChange From Baseline in Family Conflict (Parent Report)2-month Follow-up1.7637 score on a scaleStandard Deviation 1.13414
Waitlist ControlChange From Baseline in Family Conflict (Parent Report)6-month Foll1.4338ow-up1.5696 score on a scaleStandard Deviation 1.0304
FCU Online + CoachChange From Baseline in Family Conflict (Parent Report)6-month Foll1.4338ow-up1.4338 score on a scaleStandard Deviation 1.10934
FCU Online + CoachChange From Baseline in Family Conflict (Parent Report)2-month Follow-up1.5202 score on a scaleStandard Deviation 0.95062
FCU Online + CoachChange From Baseline in Family Conflict (Parent Report)4-month Follow-up1.3254 score on a scaleStandard Deviation 0.97202
FCU Online + CoachChange From Baseline in Family Conflict (Parent Report)Baseline1.8559 score on a scaleStandard Deviation 1.01044
p-value: 0.065ANOVA
Primary

Change From Baseline in Parental Stress (Parent Report)

Parents reported on their parenting stress using the Parenting Stress Index (PSI), a 14-item questionnaire. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never, almost never, sometimes, fairly often, very often). Scores ranged from 0-4. High scores indicate greater parenting stress.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Parental Stress (Parent Report)4-month Follow-up1.7616 score on a scaleStandard Deviation 0.50651
Waitlist ControlChange From Baseline in Parental Stress (Parent Report)2-month Follow-up1.8033 score on a scaleStandard Deviation 0.5193
Waitlist ControlChange From Baseline in Parental Stress (Parent Report)6-month Follow-up1.6619 score on a scaleStandard Deviation 0.46722
Waitlist ControlChange From Baseline in Parental Stress (Parent Report)Baseline1.8205 score on a scaleStandard Deviation 0.50818
FCU Online + CoachChange From Baseline in Parental Stress (Parent Report)6-month Follow-up1.5575 score on a scaleStandard Deviation 0.67258
FCU Online + CoachChange From Baseline in Parental Stress (Parent Report)2-month Follow-up1.5365 score on a scaleStandard Deviation 0.60099
FCU Online + CoachChange From Baseline in Parental Stress (Parent Report)4-month Follow-up1.5351 score on a scaleStandard Deviation 0.64845
FCU Online + CoachChange From Baseline in Parental Stress (Parent Report)Baseline1.8341 score on a scaleStandard Deviation 0.61821
Primary

Change From Baseline in Parenting Skills (Parent Report)

Parents reported on their parenting skills using a version of the Parenting Young Children Questionnaire (PARYC). The PARYC version adapted for this study was a 21-item questionnaire. Parents were asked to indicate the extent to which statements were true of their child's behavior in the past month using a 5-pt scale (never, rarely, sometimes, often, and very often). Scores for each item ranged from 0-4, and scores were averaged to create a total score. High scores indicate greater parenting skills.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Parenting Skills (Parent Report)4-month Follow-up2.9155 score on a scaleStandard Deviation 0.71707
Waitlist ControlChange From Baseline in Parenting Skills (Parent Report)Baseline2.9253 score on a scaleStandard Deviation 0.66703
Waitlist ControlChange From Baseline in Parenting Skills (Parent Report)6-month Follow-up2.9375 score on a scaleStandard Deviation 0.74085
Waitlist ControlChange From Baseline in Parenting Skills (Parent Report)2-month Follow-up2.8611 score on a scaleStandard Deviation 0.74693
FCU Online + CoachChange From Baseline in Parenting Skills (Parent Report)6-month Follow-up2.9627 score on a scaleStandard Deviation 0.69257
FCU Online + CoachChange From Baseline in Parenting Skills (Parent Report)4-month Follow-up3.1532 score on a scaleStandard Deviation 0.64394
FCU Online + CoachChange From Baseline in Parenting Skills (Parent Report)2-month Follow-up3.1286 score on a scaleStandard Deviation 0.65212
FCU Online + CoachChange From Baseline in Parenting Skills (Parent Report)Baseline2.9122 score on a scaleStandard Deviation 0.72319
p-value: 0.138ANOVA
Primary

Change From Baseline in Parent Mental Health and Well-being (Parent Report)

Parents reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Parent Mental Health and Well-being (Parent Report)4-month Follow-up.6182 score on a scaleStandard Deviation 0.42444
Waitlist ControlChange From Baseline in Parent Mental Health and Well-being (Parent Report)Baseline.7442 score on a scaleStandard Deviation 0.53193
Waitlist ControlChange From Baseline in Parent Mental Health and Well-being (Parent Report)6-month Follow-up.5386 score on a scaleStandard Deviation 0.46832
Waitlist ControlChange From Baseline in Parent Mental Health and Well-being (Parent Report)2-month Follow-up.6484 score on a scaleStandard Deviation 0.5
FCU Online + CoachChange From Baseline in Parent Mental Health and Well-being (Parent Report)6-month Follow-up.5359 score on a scaleStandard Deviation 0.61996
FCU Online + CoachChange From Baseline in Parent Mental Health and Well-being (Parent Report)2-month Follow-up.5571 score on a scaleStandard Deviation 0.51995
FCU Online + CoachChange From Baseline in Parent Mental Health and Well-being (Parent Report)Baseline.7523 score on a scaleStandard Deviation 0.61536
FCU Online + CoachChange From Baseline in Parent Mental Health and Well-being (Parent Report)4-month Follow-up.4903 score on a scaleStandard Deviation 0.54089
p-value: 0.548ANOVA
Primary

Change From Baseline in Positive Family Relationships (Child Report)

Youth reported on their family relationships using a family togetherness scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Youth were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.

Time frame: baseline, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Positive Family Relationships (Child Report)Baseline3.6061 score on a scaleStandard Deviation 1.06613
Waitlist ControlChange From Baseline in Positive Family Relationships (Child Report)6-month Follow-up3.4453 score on a scaleStandard Deviation 1.15739
FCU Online + CoachChange From Baseline in Positive Family Relationships (Child Report)Baseline3.5699 score on a scaleStandard Deviation 1.10865
FCU Online + CoachChange From Baseline in Positive Family Relationships (Child Report)6-month Follow-up3.4909 score on a scaleStandard Deviation 1.17563
p-value: 0.388ANOVA
Primary

Change From Baseline in Positive Family Relationships (Parent Report)

Parents reported on their family relationships using a family togetherness scale adapted from the Community Action for Successful Youth (CASEY) questionnaire. The scale used for this study consisted of 3 items. Parents were asked to indicate the extent to which statements were true of their experience in the past month using a 5-pt scale (never true, sometimes true, true about half the time, often true, and always true). Scores ranged from 1-5. High scores indicate greater positive family relationships.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Positive Family Relationships (Parent Report)Baseline3.3798 score on a scaleStandard Deviation 0.85888
Waitlist ControlChange From Baseline in Positive Family Relationships (Parent Report)2-month Follow-up3.3014 score on a scaleStandard Deviation 0.80539
Waitlist ControlChange From Baseline in Positive Family Relationships (Parent Report)4-month Follow-up3.4437 score on a scaleStandard Deviation 0.72097
Waitlist ControlChange From Baseline in Positive Family Relationships (Parent Report)6-month Follow-up3.5662 score on a scaleStandard Deviation 0.82904
FCU Online + CoachChange From Baseline in Positive Family Relationships (Parent Report)6-month Follow-up3.5637 score on a scaleStandard Deviation 0.97609
FCU Online + CoachChange From Baseline in Positive Family Relationships (Parent Report)Baseline3.4189 score on a scaleStandard Deviation 0.88804
FCU Online + CoachChange From Baseline in Positive Family Relationships (Parent Report)4-month Follow-up3.7566 score on a scaleStandard Deviation 0.94888
FCU Online + CoachChange From Baseline in Positive Family Relationships (Parent Report)2-month Follow-up3.6833 score on a scaleStandard Deviation 0.91161
p-value: 0.114ANOVA
Primary

Change From Baseline in Youth Depression (Child Report)

Youth reported on their depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire modified for teen use. Youth were asked to indicate the extent to which statements were true of their mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores for each item ranged from 1-4, and scores were averaged to create a total score. High scores indicate greater depressive symptoms.

Time frame: baseline, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Youth Depression (Child Report)Baseline1.7708 score on a scaleStandard Deviation 0.71537
Waitlist ControlChange From Baseline in Youth Depression (Child Report)6-month Follow-up1.8070 score on a scaleStandard Deviation 0.73077
FCU Online + CoachChange From Baseline in Youth Depression (Child Report)Baseline1.6029 score on a scaleStandard Deviation 0.62672
FCU Online + CoachChange From Baseline in Youth Depression (Child Report)6-month Follow-up1.7596 score on a scaleStandard Deviation 0.69644
p-value: 0.394ANOVA
Primary

Change From Baseline in Youth Depression (Parent Report)

Parents reported on their child's depressive symptoms using the Patient Health Questionnaire (PHQ-9), a 9-item brief depression screening questionnaire. Parents were asked to indicate the extent to which statements were true of their child's mood in the past two weeks using a 4-pt scale (not at all, several days, more than half the days, nearly every day). Scores ranged from 0-3. High scores indicate greater depressive symptoms.

Time frame: baseline, 2 months, 4 months, 6 months

Population: Number of participants differs between baseline and follow-up waves due to attrition (e.g., participants not returning follow-up surveys).

ArmMeasureGroupValue (MEAN)Dispersion
Waitlist ControlChange From Baseline in Youth Depression (Parent Report)4-month Follow-up.4589 score on a scaleStandard Deviation 0.46516
Waitlist ControlChange From Baseline in Youth Depression (Parent Report)6-month Follow-up.4810 score on a scaleStandard Deviation 0.47972
Waitlist ControlChange From Baseline in Youth Depression (Parent Report)Baseline.6092 score on a scaleStandard Deviation 0.54218
Waitlist ControlChange From Baseline in Youth Depression (Parent Report)2-month Follow-up.5219 score on a scaleStandard Deviation 0.49215
FCU Online + CoachChange From Baseline in Youth Depression (Parent Report)2-month Follow-up.5423 score on a scaleStandard Deviation 0.51117
FCU Online + CoachChange From Baseline in Youth Depression (Parent Report)4-month Follow-up.4925 score on a scaleStandard Deviation 0.51814
FCU Online + CoachChange From Baseline in Youth Depression (Parent Report)Baseline.6937 score on a scaleStandard Deviation 0.59356
FCU Online + CoachChange From Baseline in Youth Depression (Parent Report)6-month Follow-up.4783 score on a scaleStandard Deviation 0.51213
p-value: 0.663ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026