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.

NCT07558005 | Not Yet Recruiting

• 1 other identifier: IRB-81858
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Wellbeing; Mental Health; Psychological; Stress; Trauma Exposure

Keywords

Trauma Intervention; CISS; Cue Centered Therapy (CCT); Single-Session Intervention; Chronic Trauma; Trauma

Outcome Measures

Primary Outcomes (10)

• Feasibility of Implementing CISS within CAMHS Services

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Secondary Outcomes (2)

• Change in Posttraumatic Stress Symptoms

  Baseline (pre-session), 3 months, 6 months

• Mean Change in School Achievement

  Three time points: Baseline, 12 months, 24 months

Study Arms (1)

Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS)

OTHER

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.

Other: Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS)

Interventions

Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS) OTHER

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.

Also known as: Single Session Intervention

Cue-Centered Therapy (CCT)-Informed Single Session Intervention (CISS)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• University of Auckland, New Zealand: collaborator
• Health New Zealand: collaborator

MeSH Terms

Conditions

Psychological Well-Being; Wounds and Injuries

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Victor Carrion, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Melody Kim, PHD (G4)

  University of Aukland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody Kim, PHD (G4)

CONTACT

0211615296; melkim@stanford.edu

Elizabeth Santana, BA, Political Science

CONTACT

6507213582; eliz5@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The John A. Turner, M.D. Endowed Chair of Child and Adolescent Psychiatry Professor and Vice-Chair, Department of Psychiatry and Behavioral Sciences Director, Early Life Stress and Resilience Program

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: April 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share