- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06978959
- Original Trial
Family Navigator Plus for Foster Parents (FN+)
January 23, 2026 updated by: Heather Risser, Northwestern University
Building Capacity for Youth Mental Wellness: Feasibility and Acceptability for a Mental Health Family Navigator Model for Foster Parents
The investigators have designed a 5-week Family Navigator Plus (FN+) educational program to support foster parents in better understanding their youth's mental health needs and in finding mental health services.
The purpose of this interventional study is to assess the the program's acceptability (e.g., satisfaction, barriers to participation, and burden), utility (e.g., how useful foster parents found the program to be), and feasibility (e.g., number referred who meet eligibility, time to complete assessments, self-reported feasibility).
The investigators hypothesize that our program will be acceptable, useful, and feasible for foster parents of youth with mental health needs.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Heather J Risser, PhD
- Phone Number: 312-848-3019
- Email: heather.risser@northwestern.edu
Study Contact Backup
- Name: Christina L Boisseau, PhD
- Phone Number: 804-332-1627
- Email: christina.boisseau@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Heather J Risser, PhD
- Phone Number: 312-848-3019
- Email: heather.risser@northwestern.edu
-
Contact:
- Christina L Boisseau, PhD
- Phone Number: 804-332-1627
- Email: christina.boisseau@northwestern.edu
-
Principal Investigator:
- Heather J Risser, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Foster parent of a youth between the ages of 6 to 17 with mental health needs
- Parent adopted child from foster care
- Living in Illinois, United States
- English or Spanish speaking
- Has access to internet and videoconferencing
Exclusion Criteria:
- Participated in the FN+ Focus Groups or PROACTIVE Parent Pilot Study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Foster Parents
Participants will consist of adult (age 18 and older) foster parents of youth between the ages of 6 and 17 with mental health needs.
Participants will be located in Illinois, and be either English or Spanish speaking.
Participants will attend a 5-week educational program (one session per week) that aims to support them in understanding child behaviors, finding and access mental health services, communicating with providers, and using technology to find support.
|
Participants will attend 5 one-on-one sessions over the course of 5 weeks; they will meet with a family navigator over video conferencing software (e.g., Zoom).
The purpose of each sessions are as follows: 1) Provide an overview of the program and help parents understand their perceptions of child behaviors, 2) Train parents to find, access, and overcome barriers to mental health services, 3) Build parent capacity in understanding how mental health treatment works and how to communicate with providers, 4) Help parents understand the common function of child behaviors, and 5) Train parents to find, evaluate, and use online mental health tools.
Participants will complete measures of child symptoms, parent activation, barriers to treatment, and/or satisfaction with the program before the intervention, immediately after the intervention, and 3 months after completing the intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
Time Frame: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)
|
The Client Satisfaction Questionnaire (CSQ-8) is an eight-item measure that assesses client satisfaction with services including its quality, utility, and relevance.
|
Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)
|
|
Post Session Questionnaire (PsQ)
Time Frame: After Completing Each Session (Weeks 1 - 5)
|
The PsQ is a measure we created to assess utility and relevance of session content and materials, and to assess if participants intended to use skills/information learned during that session.
|
After Completing Each Session (Weeks 1 - 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Activation Measure - Mental Health
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
The Parent-Patient Activation Measure - Mental Health measures parent activation, defined as the knowledge, ability, and confidence to manage their child's mental health care.
It consists of 13 items on a 4-point Likert-type scale ranging from 1-4.
Item scores are summed for a total composite score ranging from 13 -52.
Composite scores are linearly transformed into scores ranging from 0 - 100.
Higher scores indicate higher activation in managing their child's mental health care.
PP-PAM-MH internal consistency is adequate, alpha = .89;
Item-measures correlations ranged from moderate to large, with a median correlation of .61.
The P-PAM-MH is positively correlated with measures of empowerment and negatively correlated with measures of strain.
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Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
|
Barriers to Treatment Participation
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
The Barriers to Treatment Participation Scale (BTPS; Kazdin et al., 1997), was designed to assess parent's perceptions of barriers to mental health treatment engagement for their children.
The scale consists of two sections.
The first section contains four subscales that measure the following constructs: stressors and obstacles that compete with treatment (20 items), treatment demands and issues (10 items), perceived relevance of treatment (8 items), and relationship with the therapist (6 items).
Response options for these 44 items range from 1 (Never a problem) to 5 (Very often a problem).
The second section includes 14 discrete events associated with early treatment termination.
Response options for this section include yes and no.
Higher scores on the measure indicate more barriers to treatment participation.
Scores on the BTPS have been associated with multiple indices measuring the child's participation in treatment.
Internal consistency for total score is α =.95, and subscales r
|
Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
|
PROMIS-Parent Proxy Pediatric Depressive Symptoms Short Form 8a (parent-report)
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
The PROMIS Parent Proxy Depressive Symptoms Short Form 8a measures negative mood and views of self, social cognition, and decreased positive affect and engagement in pediatric populations aged 5- to 17-years old (Irwin, et al., 2012).
Parents respond to 8 items assessing their child's symptoms of depression.
Response options range from 1 (never) to 5 (almost always).
Higher scores indicate higher levels of depressive symptoms.
Scores are reported as T-scores ranging from 35-82, with a mean of 50 and standard deviation of 10 in the sample referenced (Irwin et al, 2010).
Higher scores indicate higher levels of depressive symptoms.
Parent proxy measures were created using Item Response Theory to support theoretically maximized reliability and validity across the trait being measured.
Parent proxy scores were strongly univocal with 89% of the general variance explained by the scale's general factor.
Internal consistency is adequate at .90.
|
Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
|
PROMIS-Parent Proxy Pediatric Anxiety Short Form 8a (parent-report)
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
The PROMIS Parent Proxy Anxiety Short Form 8a measures symptoms of fear, anxious misery, hyperarousal, and somatic symptoms related to arousal among pediatric populations aged 5- to 17-years old (Irwin, et al., 2012).
Parents respond to 8 items assessing their child's symptoms of anxiety.
Response options range from 1 (never) to 5 (almost always).
Higher scores indicate higher levels of anxiety.
Scores are reported as T-scores ranging from 32-84, with a mean of 50 and standard deviation of 10 in the sample referenced (Irwin et al, 2010).
Higher scores indicate higher levels of anxiety.
The measure was created using Item Response Theory to support theoretically maximized reliability and validity across the trait being measured.
The parent proxy version was validated against other proxy measures to ensure content and discriminant validity.
Parent proxy scores were strongly univocal with 87% of the general variance explained by the scale's general factor.
Internal consistency = .90.
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Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
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Pediatric Symptoms Checklist - 17 (Parent Report)
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
|
The Pediatric Symptom Checklist - 17 (PSC-17) was designed to assess psychosocial function in children.
The measures includes three subscales that assess symptoms associated with internalizing, externalizing, and attention problems.
Response options range from 0 (Never) to 2 (Often).
The parent report version is used with children aged 5- to 17- years.
T scores range from 0-34, with at or above 15 indicating the presence of a psychosocial impairment.
Internalizing or Attention subscale scores at or above 5, and Externalizing scores at or above 7, indicate impairment.
The measure has been validated in the general child population.
Parent-reported internal consistency range from .79-.83, and overall reliability as .89.
A large-scale replication study confirmed reliability was high, with both internal consistency and test-retest reliability both at, or above, 0.85 on the parent report form.
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Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather J Risser, PhD, Northwestern University
- Study Director: Enrollment Contact, If interested in participation, Northwestern University email FNplus@northwestern.edu
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Risser, H. J., Morford, A. E., Murphy, A. N., Pinkerton, L. M., Law, C., Yang, Y., ... & Boisseau, C. L. (2024). Feasibility and acceptability of a family navigator program to support foster parents of youth with mental health concerns. Children and Youth Services Review, 160, 107578.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
May 1, 2025
First Submitted That Met QC Criteria
May 9, 2025
First Posted (Actual)
May 18, 2025
Study Record Updates
Last Update Posted (Actual)
January 27, 2026
Last Update Submitted That Met QC Criteria
January 23, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- STU00222882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Per NIMH Data Sharing policy, de-identified IDP will be shared in the NIMH Data Archive (NDA, https://nda.nih.gov/)
IPD Sharing Time Frame
Per NIMH Data Sharing policy
IPD Sharing Access Criteria
Per NIMH Data Sharing policy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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