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InterventionFN+NCT06978959

Family Navigator Plus for Foster Parents

A study testing FN+ Intervention in people with Intervention, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Intervention
What is being tested?
FN+ Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
12 Jan 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Participated in the FN+ Focus Groups or PROACTIVE Parent Pilot Study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heather J Risser, PhD contact

312-848-3019

heather.risser@northwestern.edu

Christina L Boisseau, PhD contact

804-332-1627

christina.boisseau@northwestern.edu

United States1 site, 1 recruiting
  • Northwestern University

    Chicago, Illinois, 60611

    Heather J Risser, PhD, 312-848-3019, heather.risser@northwestern.edu

    Christina L Boisseau, PhD, 804-332-1627, christina.boisseau@northwestern.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions
Intervention
Being tested
FN+ Intervention
Keywords
foster parents, family navigator, psychoeducation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FN+ InterventionBehavioural

    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.

Study groups in NCT06978959
Study groupRoleWhat they receive
Foster ParentsExperimentalParticipants 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.
Receives: Behavioral: FN+ Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Client Satisfaction Questionnaire (CSQ)

    The Client Satisfaction Questionnaire (CSQ-8) is an eight-item measure that assesses client satisfaction with services including its quality, utility, and relevance.

    Measured: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)

  2. Post Session Questionnaire (PsQ)

    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.

    Measured: After Completing Each Session (Weeks 1 - 5)

Secondary outcomes (5)
  1. Parent Activation Measure - Mental Health

    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.

    Measured: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

  2. Barriers to Treatment Participation

    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

    Measured: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

  3. PROMIS-Parent Proxy Pediatric Depressive Symptoms Short Form 8a (parent-report)

    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.

    Measured: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

  4. PROMIS-Parent Proxy Pediatric Anxiety Short Form 8a (parent-report)

    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.

    Measured: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

  5. Pediatric Symptoms Checklist - 17 (Parent Report)

    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.

    Measured: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start12 Jan 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978959
Sponsor's protocol ID
STU00222882
Acronym
FN+
Status last verified
Jan 2026
First submitted
1 May 2025
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per NIMH Data Sharing policy, de-identified IDP will be shared in the NIMH Data Archive (NDA, https://nda.nih.gov/)

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.

Questions about this trial

What is this clinical trial studying?

A study testing FN+ Intervention in people with Intervention, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heather J Risser, PhD (312-848-3019, heather.risser@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Client Satisfaction Questionnaire (CSQ) (time frame: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06978959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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