Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy (PSC-TF-CBT)to Reduce Trauma Symptoms and Negative Mental Health Sequelae
27. august 2026 oppdatert av: Funlola Are, The University of Texas Health Science Center, Houston
Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy to Reduce Trauma Symptoms and Negative Mental Health Sequelae
The purpose of this study is to evaluating the feasibility of delivering a trauma-focused intervention among children with elevated traumatic stress symptoms in primary care
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Funlola G Are, PhD
- Telefonnummer: (713) 486-2700
- E-post: Funlola.G.Are@uth.tmc.edu
Studer Kontakt Backup
- Navn: Kofoworola Bombata
- E-post: Kofoworola.Bombata@uth.tmc.edu
Studiesteder
-
-
Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
-
Ta kontakt med:
- Kofoworola Bombata
- E-post: Kofoworola.Bombata@uth.tmc.edu
-
Ta kontakt med:
- Funlola G Are, PhD
- Telefonnummer: 713-486-2700
- E-post: Funlola.G.Are@uth.tmc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- able to read or understand English
Exclusion Criteria:
- Currently receiving mental health treatment elsewhere
Clinical exclusion criteria:
- Evidence of active suicidality
- Presence of psychotic symptoms
Severe psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as:
- Score ≥ 40 on the child-report measure, or
- Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: PSC-TF-CBT
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The intervention is a stepped-care adaptation of Trauma-Focused Cognitive Behavioral Therapy (PSC-TF-CBT) delivered within pediatric primary care.
Treatment intensity is matched to each participant's individual clinical needs, with participants receiving lower-intensity intervention components initially and progressing to more intensive trauma-focused treatment as clinically indicated.
PSC-TF-CBT incorporates trauma-focused cognitive behavioral therapy strategies for youth and includes caregiver involvement.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility as assessed by the number of participants recruited
Tidsramme: From baseline to end of study (30 weeks form baseline)
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From baseline to end of study (30 weeks form baseline)
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Feasibility as assessed by the number of participants enrolled in the study
Tidsramme: end of study (30 weeks form baseline)
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end of study (30 weeks form baseline)
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Feasibility as assessed by the number of participants retained in the study
Tidsramme: end of study (30 weeks form baseline)
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Retained is described as participants who enroll in the study and remain enrolled through the study endpoint/final.
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end of study (30 weeks form baseline)
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Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant
Tidsramme: From baseline to end of study (30 weeks form baseline)
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From baseline to end of study (30 weeks form baseline)
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Feasibility as assessed by number of participants that completed the intervention
Tidsramme: end of study (30 weeks from baseline)
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end of study (30 weeks from baseline)
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Change in acceptability by youth as assessed by participant satisfaction questionnaires
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Satisfaction will be assessed using a 10-item questionnaire.
Participants will respond to each item with either "Agree" or "Disagree."
The total number of "Agree" responses will be calculated, resulting in a total score ranging from 0 to 10.
A higher number of "Agree" responses indicates greater satisfaction.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability by caregiver as assessed by participant satisfaction questionnaires
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 13 item questionnaire and each is scored from 1(very dissatisfied) to 7 (Very satisfied) for a score range of 13-91, higher scores indicating better outcome
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability of the intervention by the youth as assessed by qualitative exit interviews
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability of the intervention by the caregiver as assessed by qualitative exit interviews
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome
|
6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Child traumatic stress symptoms as assessed by the Child Trauma Screen (CTS)
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 10 item questionnaire divided into 2 components: Four items assess exposure to potentially traumatic events using a yes/no response format, and six items assess PTSD-related reactions using a 4-point response scale scored from 0 to 3. The six reaction items are summed to produce a Reactions Total score ranging from 0 to 18, with higher scores indicating greater traumatic stress symptom severity. A Reactions Total score of ≥6 indicates a high likelihood of clinically significant PTSD symptoms |
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), (parent report )
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
|
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
|
Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (child's self-report)
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
|
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
|
Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (parent report)
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms
|
Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
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Change in emotional and behavioral problems as assessed by the Pediatric Symptom Checklist-17 (PSC-17)
Tidsramme: Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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The Pediatric Symptom Checklist-17 (PSC-17) is a 17-item screening measure of psychosocial, emotional, and behavioral problems in children and adolescents.
Each item is rated on a 3-point scale from 0 (Never) to 2 (Often).
Item scores are summed to generate a Total Problems Score, ranging from 0 to 34, with higher scores indicating greater emotional and behavioral difficulties.
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Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 4-item implementation outcome measure rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
Scores will be calculated by averaging item responses , with higher scores indicating greater perceived appropriateness.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Change in acceptability as assessed by the Acceptability of Intervention Measure (AIM)
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree).
The four item scores are averaged to generate an overall AIM score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Feasibility as assessed by the Feasibility of Intervention Measure (FIM).
Tidsramme: 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
|
This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree) for a maximum score range of 1-20,with higher scores indicating greater perceived feasibility of the intervention.
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6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Funlola G Are, The University of Texas Health Science Center, Houston
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
31. august 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
27. august 2026
Først innsendt som oppfylte QC-kriteriene
27. august 2026
Først lagt ut (Faktiske)
1. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HSC-MS-26-0466
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