Trial Outcomes & Findings for Foster Care Mental Health Family Navigator (NCT NCT04506437)

NCT ID: NCT04506437

Last Updated: 2026-06-30

Results Overview

Number of days until treatment referral is made

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

12 months post enrollment

Results posted on

2026-06-30

Participant Flow

A total of 76 participants were recruited as youth-caregiver dyads. There were a total of 38 participants (or 19 youth-caregiver dyads) in each condition.

Participant milestones

Participant milestones
Measure	Family-based Mental Health Navigation Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement	Standard of Care (Clinic Case Management) Standard of care engagement practices: Standard of care engagement practices and services-as-usual
Overall Study STARTED	38	38
Overall Study Youth Participants	19	19
Overall Study Caregiver Participants	19	19
Overall Study COMPLETED	38	38
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: Time to treatment referral data were available for only 26 youth participants (13 in the family-based mental health navigation intervention and 13 in the standard of care condition) due to changes in the electronic medical record system.

Number of days until treatment referral is made

Outcome measures

Outcome measures
Measure	Standard of Care (Clinic Case Management) n=13 Participants Standard of care case management practices and services-as-usual	Family-based Mental Health Navigation n=13 Participants Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Time to Treatment Referral	13 days Interval 0.0 to 71.0	56 days Interval 12.0 to 169.0

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: Time to treatment initiation data were only available for 4 youth participants in the family-based mental health navigation intervention and 1 youth participant in the standard of care condition.

Number of days until attendance at first treatment session

Outcome measures

Outcome measures
Measure	Standard of Care (Clinic Case Management) n=1 Participants Standard of care case management practices and services-as-usual	Family-based Mental Health Navigation n=4 Participants Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Time to Treatment Initiation	2 days Interval 2.0 to 2.0	3 days Interval 3.0 to 19.0

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: Treatment engagement data were only available for 10 youth participants in the family-based mental health navigation intervention and 3 youth participants in the standard of care condition.

Engagement as measured by attendance in treatment for 6 or more weeks

Outcome measures

Outcome measures
Measure	Standard of Care (Clinic Case Management) n=3 Participants Standard of care case management practices and services-as-usual	Family-based Mental Health Navigation n=10 Participants Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
Treatment Engagement: Number of Participants in Treatment for 6 or More Weeks	1 Participants	5 Participants

Adverse Events

Family-based Mental Health Navigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care (Clinic Case Management)

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

Jannet Lara Salas

University of San Francisco, California

Phone: 415-962-6972

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Family-based Mental Health Navigation n=38 Participants Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement Family-based mental health navigation: Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement	Standard of Care (Clinic Case Management) n=38 Participants Standard of care case management practices and services-as-usual	Total n=76 Participants Total of all reporting groups
Age, Continuous Youth Age Demographics	14.47 years n=19 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	14.22 years n=19 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	14.39 years n=38 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Age, Continuous Caregiver Age Demographics	43.88 years n=19 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	45.11 years n=19 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	44.53 years n=38 Participants • Age demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Sex: Female, Male Youth Sex Demographics · Female	10 Participants n=18 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	10 Participants n=19 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	20 Participants n=37 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.
Sex: Female, Male Youth Sex Demographics · Male	8 Participants n=18 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	9 Participants n=19 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	17 Participants n=37 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.
Race (NIH/OMB) Youth Race Demographics · White	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Sex: Female, Male Caregiver Sex Demographics · Female	16 Participants n=16 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	16 Participants n=18 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	32 Participants n=34 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.
Sex: Female, Male Caregiver Sex Demographics · Male	0 Participants n=16 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	2 Participants n=18 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.	2 Participants n=34 Participants • Sex demographic data for youth and caregivers were analyzed separately across the intervention and control conditions. Note: Sex demographic data were missing for 1 youth in the intervention condition (did not complete baseline), 3 caregivers in the intervention condition (did not complete baseline), and 1 caregiver in the control condition (did not complete baseline). Note that this was an intent to treat trial design.
Race (NIH/OMB) Youth Race Demographics · American Indian or Alaska Native	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Youth Race Demographics · Asian	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	2 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	2 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Youth Race Demographics · Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Youth Race Demographics · Black or African American	5 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	4 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	9 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Youth Race Demographics · More than one race	1 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	1 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Youth Race Demographics · Unknown or Not Reported	13 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	13 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	26 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · American Indian or Alaska Native	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · Asian	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	1 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	1 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · Native Hawaiian or Other Pacific Islander	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · Black or African American	7 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	4 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	11 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · White	1 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	2 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	3 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · More than one race	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	0 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.
Race (NIH/OMB) Caregiver Race Demographics · Unknown or Not Reported	11 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	12 Participants n=19 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.	23 Participants n=38 Participants • Race demographic data for youth and caregivers were analyzed separately across the intervention and control conditions.