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

3 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Comparador Ativo: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Post Session Questionnaire
Prazo: 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)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Parent-Patient Activation Measure - Mental Health
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Northwestern University

Colaboradores

National Institute of Mental Health (NIMH)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de setembro de 2026

Conclusão Primária (Estimado)

30 de setembro de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de setembro de 2026

Primeira postagem (Real)

4 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • STU00225845
  • 5R34MH134941 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

Per NIMH data sharing policy

Critérios de acesso de compartilhamento IPD

Per NIMH data sharing policy

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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