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Building Capacity for Youth Mental Wellness: Family Navigator Model for Foster Parents (FN+)

3 settembre 2026 aggiornato da: Heather Risser, Northwestern University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Family Navigator Plus
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.
Comportamentale: Family Navigation
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.
Comparatore attivo: Civic Engagement Plus
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.
Comportamentale: Civic Engagement Plus
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Post Session Questionnaire
Lasso di tempo: Time Frame: After Completing Each Session (Weeks 1 - 5)
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.
Time Frame: After Completing Each Session (Weeks 1 - 5)
Client Satisfaction Questionnaire (CSQ)
Lasso di tempo: Time Frame: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)
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.
Time Frame: Post-Intervention (Week 5) and 3 Month Follow Up (Week 18)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parent-Patient Activation Measure - Mental Health
Lasso di tempo: Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
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.
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
Barriers to Treatment Participation Scale
Lasso di tempo: Baseline (week 1), Post-Intervention (week 5), 3 month Follow - Up (week 18)
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
Baseline (week 1), Post-Intervention (week 5), 3 month Follow - Up (week 18)
PROMIS Parent Proxy Depressive Symptoms Short Form
Lasso di tempo: Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)
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.
Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)
PROMIS Parent Proxy Anxiety Short Form
Lasso di tempo: Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)
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
Time Frame: Baseline (Week 1), Post-intervention (week 5), 3 month follow up (week 18)
Pediatric Symptom Checklist - 17
Lasso di tempo: Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)
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.
Time Frame: Baseline (Week 1), Post-Intervention (Week 5), 3 month Follow Up (Week 18)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Northwestern University

Collaboratori

National Institute of Mental Health (NIMH)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 settembre 2026

Completamento primario (Stimato)

30 settembre 2027

Completamento dello studio (Stimato)

30 settembre 2027

Date di iscrizione allo studio

Primo inviato

1 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 settembre 2026

Primo Inserito (Effettivo)

4 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • STU00225845
  • 5R34MH134941 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Per NIMH Data Sharing policy, de-identified IDP will be shared in the NIMH Data Archive (NDA, https://nda.nih.gov/)

Periodo di condivisione IPD

Per NIMH data sharing policy

Criteri di accesso alla condivisione IPD

Per NIMH data sharing policy

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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