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Family Navigator PlusPhase 2FN+NCT07805395

Building Capacity for Youth Mental Wellness: Family Navigator Model for Foster Parents

A Phase 2 study testing Family Navigation and Civic Engagement Plus in people with Family Navigator Plus and Civic Engagement Plus, 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 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Family Navigator Plus, Civic Engagement Plus
What is being tested?
Family Navigation and Civic Engagement Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Sep 2026to 30 Sep 2027
Phase
Phase 2
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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Foster parent, kinship caregiver, or guardian, 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 speaking
  • Has access to internet and videoconferencing

Who cannot join

  • Participated in the FN+ Focus Groups, Open Trial 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.

Christina Boisseau, PhD contact

312-5033270

christina.boisseau@northwestern.edu

United States1 site, 1 recruiting
  • Northwestern University

    Chicago, Illinois, 60611

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

    heather.risser@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 (FN+ Phase 2)

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), compared to Attention Control (AC). The investigators hypothesize that our program will be acceptable, useful, and feasible for foster parents of youth with mental health needs.

Read the detailed description

We will conduct a pilot RCT (n = 60) as a test of the FN+ Program feasibility and preliminary effectiveness to improve individual-level variables, relative to Attention Control (AC). The primary outcome will be increased foster parent activation (P-PAM-MH). Secondary outcomes include reduced barriers to treatment and perceived change in parent capacity to manage youth MH care. Randomization: We will use simple randomization to assign foster parents to condition. Foster parents (n=60) will be randomized to the either the FN+ or AC. We will pilot all randomization procedures including those designed to prevent allocation bias. Randomization will be conducted by a research analyst who is blind to hypotheses and is not involved in any other aspect of the study. The research analyst will only share the names and condition assignment with the FNs who do not know study aims or hypotheses and will keep research staff blinded to condition. The ACHW will conduct all outcome data and remain blind to condition. The ACHW will remain masked to treatment assignment until the trial is complete. Success in masking will be monitored using the Evaluator Masking Assessment upon the completion of each data collection time point for each parent. Inclusion and Exclusion criteria are the same as Aim 2 with the addition that any foster parent that participated in Aim 1 or 2 will be excluded from the RCT.

Being tested
Family Navigation, Civic Engagement Plus

What participants receive

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

  • Family NavigationBehavioural

    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.

  • Civic Engagement PlusBehavioural

    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) defines civic engagement within a developmental framework, and guides foster parents in discussing their child's developmental level, strengths, and opportunities for civic participation. 2) identifies developmentally appropriate civic activities and strategies to initiate and support youth involvement. 3) emphasizes goal setting, age-appropriate engagement strategies, collaboration with caseworkers, and structured problem-solving to address barriers to participation. 4) setting developmentally appropriate goals, 5) finding digital 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 NCT07805395
Study groupRoleWhat they receive
Family Navigator PlusExperimentalParticipants 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.
Receives: Behavioral: Family Navigation
Civic Engagement PlusActive comparatorParticipants 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) defines civic engagement within a developmental framework, and guides foster parents in discussing their child's developmental level, strengths, and opportunities for civic participation. 2) identifies developmentally appropriate civic activities and strategies to initiate and support youth involvement. 3) emphasizes goal setting, age-appropriate engagement strategies, collaboration with caseworkers, and structured problem-solving to address barriers to participation. 4) setting developmentally appropriate goals, 5) finding digital 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.
Receives: Behavioral: Civic Engagement Plus

What is being measured

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

  1. Post Session Questionnaire

    Description: The Post Session Questionnaire 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. Response options range from 1 - 4. Higher scores mean participants found the content more useful.

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

  2. Client Satisfaction Questionnaire (CSQ)

    Description: The Client Satisfaction Questionnaire (CSQ-8) is an eight-item measure that assesses client satisfaction with services including its quality, utility, and relevance. Response options range from 1 - 4. Higher scores mean participants found to be of high quality, met their needs, etc.

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

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

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

  2. Barriers to Treatment Participation Scale

    Description: 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, an

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

  3. PROMIS Parent Proxy Depressive Symptoms Short Form

    Description: 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: Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)

  4. PROMIS Parent Proxy Anxiety Short Form

    Description: 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 consistenc

    Measured: Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)

  5. Pediatric Symptom Checklist - 17

    Description: 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: Time Frame: 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 posted4 Sep 2026
  2. Study start5 Sep 2026 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomly assigned to one of two conditions.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07805395
Sponsor's protocol ID
STU00225845
Other IDs
5R34MH134941
Acronym
FN+
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
9 Sep 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/)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Family Navigation and Civic Engagement Plus in people with Family Navigator Plus and Civic Engagement Plus, 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 9 Sep 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Risser, PhD (3128483019, heather.risser@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Session Questionnaire (time frame: Time Frame: After Completing Each Session (Weeks 1 - 5)). 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?
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 9 Sep 2026.

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