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Many Trauma-affected Youth Face Long Waits for Therapy, Worsening Stress, and Avoidance. CISS, a 90-minute Session Based on Stanford's Cue-Centered Therapy, Offers Coping Tools and Psychoeducation During This Gap. This Pilot Tests CISS's Feasibility, Acceptability, and Impact on 30-40 Adolescents. (CISS)

22 aprile 2026 aggiornato da: Victor Carrion, Stanford University

CISS: CCT-Informed Single Session Intervention

Many young people who have experienced traumatic events such as sexual assault, domestic violence, serious accidents, or natural disasters face long waits before they can begin full trauma-focused therapy. During this waiting period, symptoms such as avoidance, anxiety, and distress may worsen, and many youth lose motivation or confidence to start treatment. The Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS) was designed to bridge this gap by offering a one-time, 90-minute session that teaches coping and self-understanding skills while youth are still on the waiting list.

This study is a pilot feasibility trial conducted in partnership between Stanford University and the University of Auckland. The purpose of the study is to evaluate whether CISS is a practical, acceptable, and safe intervention for young people aged 13-18 who have been exposed to trauma and are currently waiting for or hesitant to begin full-length therapy within New Zealand Hapai Ora Clinics.

Youth participants will meet once with a trained Hapai Ora clinician who will deliver the 90-minute CISS session. The session combines psychoeducation about trauma cues with skill-building strategies to improve coping, confidence, and readiness to engage in future treatment. Participants will complete short questionnaires before and after the session, and again at 3- and 6-month follow-ups. Measures will assess coping self-efficacy, treatment readiness, posttraumatic stress symptoms, and whether participants eventually begin full-length therapy.

The study will recruit approximately 30-40 adolescents across Hapai Ora clinical sites in Auckland, New Zealand. All clinicians providing the intervention are qualified mental-health professionals trained in both CISS and child-safety protocols. Participation involves minimal risk-similar to discussing difficult topics in a supportive therapy session.

Findings from this pilot study will help researchers understand whether CISS can be feasibly and safely delivered within public mental-health services, and whether it shows promise in helping young people build coping skills, reduce avoidance, and increase readiness to start therapy. The results will guide future larger-scale trials and inform the development of single-session, early-intervention approaches for trauma-exposed youth worldwide.

Panoramica dello studio

Descrizione dettagliata

Trauma-exposed youth often face months-long waits before beginning comprehensive trauma-focused therapy, leaving them without structured support during a critical period of need. During these waiting periods, symptoms such as avoidance, anxiety, and hyperarousal may worsen, and many young people lose motivation or confidence to begin care. Brief, single-session interventions (SSIs) have emerged as a promising approach to strengthen coping and treatment engagement among youth unable or unwilling to access longer-term therapy.

The Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS) is a 90-minute, structured, one-on-one session derived from the evidence-based Cue-Centered Therapy model developed at Stanford University's Early Life Stress and Resilience Program. CISS distills key CCT components-psychoeducation about trauma cues, development of insight into avoidance patterns, and flexible coping skill practice-into a single, accessible format designed to serve as a "bridge-to-care" for youth awaiting therapy.

This pilot feasibility trial will evaluate whether CISS can be feasibly and safely delivered to adolescents (ages 13-18) who have been exposed to trauma and are currently on Hapai Ora waitlists in New Zealand. The study is a collaboration between Stanford University and the University of Auckland.

Primary objectives:

  • Assess the feasibility and acceptability of CISS delivery within routine Hapai Ora workflows.
  • Examine pre- to post-intervention changes in coping self-efficacy, treatment readiness, and posttraumatic stress symptoms (PTSD symptoms).
  • Explore treatment uptake and engagement in full-length trauma therapy following participation.

Approximately 30-40 adolescents will be recruited through collaborating Hapai Ora sites. After informed consent or assent, participants will complete baseline questionnaires, attend a single 90-minute CISS session with a trained clinician, and complete post-session, 3-month, and 6-month follow-up assessments. All measures are brief, self-reported, and non-invasive. Core instruments include:

  • Children's Revised Impact of Event Scale (CRIES-8): measuring posttraumatic stress symptom severity (primary PTSD outcome)
  • Motivation for Youth Treatment Scale - Readiness Subscale (MYTS-R): measuring treatment readiness

    -.Credibility and Expectancy Questionnaire - Youth, Trauma-Focused (CEQ-Y-TF): measuring perceived credibility and expectancy of benefit

  • General Help-Seeking Questionnaire (GHSQ): measuring coping self-efficacy and help-seeking intentions

The study uses a single-group, pre-post feasibility design. Sessions are delivered by licensed Hapai Oraclinicians (e.g., psychologists, psychiatrists, nurses, or social workers) trained in CISS through Stanford- and Auckland-led workshops. Fidelity is monitored through checklists and optional video review for supervision. Data will be stored securely on Stanford Medicine's Qualtrics and Box servers, with all identifiable information removed prior to analysis.

Risks are minimal and limited to temporary emotional discomfort when discussing past trauma. All clinicians follow standard crisis-management and child-safety procedures, and participants have access to ongoing clinical support through Hapai Ora. No invasive procedures or medications are involved.

The anticipated study duration is from December 2025 to November 2028. Primary data collection (including 6-month follow-ups) is expected to conclude by May 2028. Findings will inform the design of a larger randomized controlled trial and contribute to international efforts to improve early trauma intervention accessibility within youth mental-health systems.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

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

  • Nome: Elizabeth Santana, BA, Political Science
  • Numero di telefono: 6507213582
  • Email: eliz5@stanford.edu

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

  • Bambino
  • Adulto

Accetta volontari sani

Descrizione

Inclusion Criteria:

  • Age: 13 to 18 years old (adolescents).

Trauma Exposure: History of chronic or single-event trauma (e.g., interpersonal violence, serious accidents, natural disaster) as documented in Child and Adolescent Mental Health Services (CAMHS) intake records.

Service Status: Currently on a CAMHS waitlist for trauma-focused therapy, or self-referred but hesitant to begin multi-session treatment.

Capacity and Consent: Ability to provide informed assent (ages 13-15 with parental permission) or informed consent (ages 16-18).

Exclusion Criteria:

Current Trauma Treatment: Actively engaged in any form of trauma-focused psychotherapy (e.g., TF-CBT, EMDR, CCT) at the time of enrollment.

Severe Cognitive Impairment: Intellectual disability or cognitive impairment (e.g., IQ < 70) that precludes comprehension of psychoeducational material or completion of self-report questionnaires.

Acute Suicidality: Endorsement of imminent self-harm or suicide risk (e.g., PHQ-9 item 9 ≥ 2) during screening that necessitates immediate crisis management rather than study participation.

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: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS)
Participants will receive a single 90-minute CISS session, a structured, therapist-led program based on Cue-Centered Therapy (CCT). The session combines psychoeducation about trauma cues, guided reflection on avoidance and stress reactions, and skills practice to strengthen coping and treatment readiness. Sessions are delivered individually by trained mental-health clinicians (psychologists, psychiatrists, nurses, or social workers) working in Child and Adolescent Mental Health Services (CAMHS). All clinicians complete CISS training and fidelity supervision before implementation.Each youth completes baseline questionnaires before the session, a brief post-session survey, and follow-up assessments at 3 and 6 months. No control group or randomization is used in this pilot feasibility design.
Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS) Arm Description: Participants will receive a single 90-minute CISS session, a structured, therapist-led program based on Cue-Centered Therapy (CCT). The session combines psychoeducation about trauma cues, guided reflection on avoidance and stress reactions, and skills practice to strengthen coping and treatment readiness. Sessions are delivered individually by trained mental-health clinicians (psychologists, psychiatrists, nurses, or social workers) working in Hapai Ora clinics. All clinicians complete CISS training and fidelity supervision before implementation.Each youth completes baseline questionnaires before the session, a brief post-session survey, and follow-up assessments at 3 and 6 months. No control group or randomization is used in this pilot feasibility design.
Altri nomi:
  • Single Session Intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of Implementing CISS within CAMHS Services
Lasso di tempo: From the study start in June 2026 for 12 weeks
Feasibility will be evaluated using quantitative indices, including recruitment rate. Recruitment feasibility will be defined as the proportion of eligible participants who consent and complete the CISS session. Implementation feasibility will be indicated by the proportion of clinicians completing training and achieving ≥85% fidelity on observed sessions. Data will be summarized descriptively to determine whether CISS can be integrated into routine Hapai Ora workflows.
From the study start in June 2026 for 12 weeks
Feasibility of Implementing CISS within CAMHS Services
Lasso di tempo: From the study start in June 2026 for 12 weeks
Feasibility will be evaluated using quantitative indices, including session completion rate. Recruitment feasibility will be defined as the proportion of eligible participants who consent and complete the CISS session. Implementation feasibility will be indicated by the proportion of clinicians completing training and achieving ≥85% fidelity on observed sessions. Data will be summarized descriptively to determine whether CISS can be integrated into routine Hapai Ora workflows.
From the study start in June 2026 for 12 weeks
Feasibility of Implementing CISS within CAMHS Services
Lasso di tempo: From the study start in June 2026 for 12 weeks
Feasibility will be evaluated using quantitative indices, including follow-up completion rate. Recruitment feasibility will be defined as the proportion of eligible participants who consent and complete the CISS session. Implementation feasibility will be indicated by the proportion of clinicians completing training and achieving ≥85% fidelity on observed sessions. Data will be summarized descriptively to determine whether CISS can be integrated into routine Hapai Ora workflows.
From the study start in June 2026 for 12 weeks
Feasibility of Implementing CISS within CAMHS Services
Lasso di tempo: From the study start in June 2026 for 12 weeks
Feasibility will be evaluated using quantitative indices, including clinician fidelity scores. Recruitment feasibility will be defined as the proportion of eligible participants who consent and complete the CISS session. Implementation feasibility will be indicated by the proportion of clinicians completing training and achieving ≥85% fidelity on observed sessions. Data will be summarized descriptively to determine whether CISS can be integrated into routine Hapai Ora workflows.
From the study start in June 2026 for 12 weeks
Acceptability of CISS to Youth Participants and Clinicians
Lasso di tempo: Immediately post-session
Acceptability will be assessed through post-session surveys completed by youth and clinicians. Youth will rate satisfaction using 5-point Likert scales (1 = Not at all, 5 = Extremely). Clinicians will complete a brief acceptability checklist evaluating ease of delivery, perceived fit with clinical practice, and satisfaction with supervision. Acceptability will be operationalized as ≥80% of youth and clinicians endorsing ratings of 4 or higher on satisfaction and helpfulness items.
Immediately post-session
Acceptability of CISS to Youth Participants and Clinicians
Lasso di tempo: Immediately post-session
Acceptability will be assessed through post-session surveys completed by youth and clinicians. Youth will rate perceived helpfulness using 5-point Likert scales (1 = Not at all, 5 = Extremely). Clinicians will complete a brief acceptability checklist evaluating ease of delivery, perceived fit with clinical practice, and satisfaction with supervision. Acceptability will be operationalized as ≥80% of youth and clinicians endorsing ratings of 4 or higher on satisfaction and helpfulness items.
Immediately post-session
Acceptability of CISS to Youth Participants and Clinicians
Lasso di tempo: Immediately post-session
Acceptability will be assessed through post-session surveys completed by youth and clinicians. Youth will rate the likelihood of recommending the session using 5-point Likert scales (1 = Not at all, 5 = Extremely). Clinicians will complete a brief acceptability checklist evaluating ease of delivery, perceived fit with clinical practice, and satisfaction with supervision. Acceptability will be operationalized as ≥80% of youth and clinicians endorsing ratings of 4 or higher on satisfaction and helpfulness items.
Immediately post-session
Change in Treatment Readiness
Lasso di tempo: Baseline (pre-session), immediate post-session, 3 months, 6 months
The Motivation for Youth Treatment Scale - Readiness Subscale (MYTS-R) measures adolescents' readiness and motivation to engage in therapy. The MYTS-R consists of 8 items rated on a 5-point Likert scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Higher scores indicate greater readiness to participate in therapy. Mean changes in MYTS-R scores will be analyzed from baseline (pre-session) to immediate post-session, 3-month, and 6-month follow-ups.
Baseline (pre-session), immediate post-session, 3 months, 6 months
Change in Coping Self-Efficacy and Help-Seeking Intentions
Lasso di tempo: Baseline (pre-session), 3 months, 6 months
The General Help-Seeking Questionnaire (GHSQ) evaluates adolescents' perceived coping ability and likelihood of seeking help for emotional or mental-health problems. Items are rated on a 7-point scale (1 = extremely unlikely, 7 = extremely likely). Higher scores indicate stronger coping self-efficacy and help-seeking intentions. Mean changes from baseline to follow-up will assess improvement in self-efficacy and help-seeking behavior.
Baseline (pre-session), 3 months, 6 months
Change in Perceived Credibility and Expectancy for Treatment
Lasso di tempo: Baseline (pre-session), immediate post-session
The Credibility and Expectancy Questionnaire - Youth, Trauma-Focused (CEQ-Y-TF) measures youths' perceptions of the intervention's credibility and their expectations of benefit. Six items are rated on 9-point Likert scales, with higher scores reflecting greater perceived credibility and expectancy. Mean CEQ-Y-TF scores will be compared between baseline and immediate post-session to assess change in perceived treatment plausibility and anticipated effectiveness.
Baseline (pre-session), immediate post-session

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Posttraumatic Stress Symptoms
Lasso di tempo: Baseline (pre-session), 3 months, 6 months
The Children's Revised Impact of Event Scale - 8 item (CRIES-8) measures posttraumatic stress symptom severity (intrusion, avoidance, and arousal). Each item is rated on a 4-point scale (0 = Not at all, 5 = Often). Higher scores indicate greater symptom severity. Mean total CRIES-8 score changes will be evaluated from baseline to 3- and 6-month follow-ups as an exploratory clinical outcome.
Baseline (pre-session), 3 months, 6 months
Mean Change in School Achievement
Lasso di tempo: Three time points: Baseline, 12 months, 24 months
Description: School achievement was assessed with the Wide Range Achievement Test-Revised Spelling and Math scale score. The spelling subscale was a phonetic test that assessed the degree to which students could encode sounds into written words. The math computation subscale measured students' ability to identify numbers, count, and solve written computational problems. The scores are summed across the subscales and scaled according to the standardized score. A higher score reflects a higher performance. Changes in scores will be assessed between all time points.
Three time points: Baseline, 12 months, 24 months

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Victor Carrion, MD, Stanford University
  • Investigatore principale: Melody Kim, PHD (G4), University of Aukland

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)

1 giugno 2026

Completamento primario (Stimato)

31 maggio 2028

Completamento dello studio (Stimato)

30 novembre 2028

Date di iscrizione allo studio

Primo inviato

8 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

22 aprile 2026

Primo Inserito (Effettivo)

30 aprile 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 aprile 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB-81858

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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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