[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07281365":3,"trial-entities:NCT07281365":130,"trial-summary:NCT07281365":135},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":48,"secondary_outcomes":53,"sex":86,"minimum_age":87,"maximum_age":88,"healthy_volunteers":89,"eligibility_criteria":90,"std_ages":105,"locations":107,"central_contacts":126,"overall_officials":127,"references":128,"see_also_links":129},"NCT07281365","24-1783","Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children","Proof-of-Concept Trial of an Emotion Regulation and Executive Functioning Intervention for SITBs in Children","NOT_YET_RECRUITING","2028-05","2026-07","2026-07-29","2026-12","University of Colorado, Denver","OTHER",true,"The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs).\n\nThe main questions it aims to answer are:\n\n1. Are the recruitment targets and study design feasible?\n2. Is the new intervention feasible, acceptable, and appropriate?\n3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets relative to treatment as usual (TAU)?\n\nIn Phase 1 (pre-implementation, months 1-6), enrolled preadolescent and caregiver dyads will receive TAU. In Phase 2 (post-implementation, months 7-13), enrolled dyads will receive the newly-developed SITB intervention. Participants will be recruited through referrals from the psychiatric emergency department at Children's Hospital Colorado. Participants will:\n\n1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation\n2. Participate in an intervention lasting 6-12 weeks, including weekly or biweekly sessions\n3. Complete additional assessments at post-treatment and 3-month follow-up\n4. Participate in an interview sharing their perceptions of the intervention","In Stage 1 of the study (Aim 1), the investigators will iteratively design an intervention for preadolescent SITBs through a step-by-step process using frameworks for systematically developing and adapting interventions (Wingood et al., 2008; Bartholomew et al., 1998). The design process will incorporate user-centered design methods, whereby multisectoral experts and end-users (i.e., therapists and families) will participate in the design process to maximize the intervention's dissemination and implementation potential. In Stage 2 of the study (Aims 2 and 3), the new intervention will be evaluated using a quasi-experimental, pre-post implementation design including 52 preadolescents and caregiver(s), recruited through the CHCO emergency department (ED) at the Anschutz Campus.\n\nIn Stage 1, the investigators will use mixed methods approaches and user-centered design principles to iteratively develop the preadolescent SITB intervention. Through a needs assessment, the investigators will use an exploratory sequential qualitative--\\> quantitative mixed methods design, whereby qualitative interviews with therapists will inform the development of a quantitative survey assessing needs and experiences of therapists treating preadolescents with SITBs. Results from the therapist assessment will be integrated with findings from qualitative interviews with preadolescents and caregiversto further inform initial decisions about core functions and specific components of the intervention. During a pre-testing phase utilizing a concurrent mixed methods approach, therapists and preadolescents\u002Ffamilies will participate in think-aloud design sessions to provide quantitative and qualitative feedback about rough intervention prototypes. An initial draft of the intervention will then be produced and reviewed by a group of experts, resulting in a second draft of the intervention and therapist training and consultation procedures. A single-arm, intervention development trial with 6 preadolescents will inform adaptations to the intervention, therapist training, and trial procedures.\n\nIn Stage 2, the investigators will evaluate the feasibility and acceptability of the study methods and intervention, implementation, and changes in SITB and mental health outcomes using a quasi-experimental, pre-post implementation design (ADAPT-ITT Step 8, Part 2). The trial will have two phases. In Phase 1 of the trial (pre-implementation, months 1-6), enrolled participants will receive treatment as usual (TAU); in Phase 2 of the trial (post-implementation, months 7-13), enrolled participants will receive the new intervention. All treatment will be delivered at the Crisis Clinic at Children's Hospital Colorado, which provides short-term (i.e., 6-12 session) outpatient crisis intervention to youth referred from the ED. Clinicians (up to N = 16) will be recruited from the Crisis Clinic to participate. During Phase 1, clinicians will provide treatment using their typical clinical practice. Prior to Phase 2, clinicians will receive training in the new intervention and will receive monthly consultation support from the developers throughout the implementation phase. Aim 2 will evaluate feasibility, acceptability, and implementation outcomes for the intervention and study procedures. Aim 3 will be to collect preliminary evidence to explore changes in SITBs, hypothesized target mechanisms of EF and emotion regulation, and mental health symptoms relative to TAU.",[19,20,21,22],"Self-injury","Suicidal Ideation and Behavior","Executive Functioning","Emotion Regulation",[24,25,26,27,28,29],"Preadolescents","Children","Self-Injury","Suicidal ideation and behavior","Feasibility","Pilot Trial","INTERVENTIONAL","TREATMENT",[33],"NA",{"count":35,"type":36},52,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"BEHAVIORAL","Treatment as usual (TAU)","Typical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement",[43],"Treatment as Usual (TAU)",{"type":39,"name":45,"description":46,"armGroupLabels":47},"Preadolescent SITB Intervention","Experimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents",[45],[49],{"measure":50,"description":51,"timeFrame":52},"Feasibility of recruitment","% recruitment targets met (benchmark = 52 preadolescents enrolled within 13 months)","Calculated at enrollment",[54,58,62,65,68,71,75,79,83],{"measure":55,"description":56,"timeFrame":57},"Suicidal Ideation Intensity","Measured using the Columbia Suicide and Self Injury Severity Rating Scale (C-SSRS; Posner et al., 2011), a brief interview that consists of sections that assess: suicidal ideation, ideation intensity, and suicidal behavior. The C-SSRS has strong convergent validity, sensitivity to change, predictive and incremental validity, and good internal consistency.","From enrollment to 3-month follow-up at 20 weeks",{"measure":59,"description":60,"timeFrame":61},"Feasibility of Retention","% participants completing treatment (benchmark =≥ 80% participants considered treatment completers)","From enrollment to the end of treatment at 8 weeks",{"measure":63,"description":64,"timeFrame":61},"Perceived Appropriateness of Intervention","The Intervention Appropriateness Measure (IAM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The IAM is a 4-item measure assessing the extent to which stakeholders believe an intervention or to be appropriate. Items are rated from 1 (\"completely disagree\") to 5 (\"completely agree\"), with higher scores indicating greater appropriateness. The appropriateness benchmark for all reporters is set at a mean score of 4 or greater.",{"measure":66,"description":67,"timeFrame":61},"Perceived Feasibility of Intervention","The Feasibility of Intervention Measure (FIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The FIM is a 4-item measures assessing the extent to which stakeholders believe an intervention to be feasible. Items are rated from 1 (\"completely disagree\") to 5 (\"completely agree\"), with higher scores indicating greater feasibility. The feasibility benchmark for all reporters is set at a mean score of 4 or greater.",{"measure":69,"description":70,"timeFrame":61},"Perceived acceptability of intervention","The Acceptability of Intervention Measure (AIM; Weiner et al., 2017) will be completed by preadolescents, caregivers, and therapists. The AIM is a 4-item measure assessing the extent to which stakeholders believe an intervention to be acceptable. Items are rated from 1 (\"completely disagree\") to 5 (\"completely agree\"), with higher scores indicating greater acceptability. The acceptability benchmark for all reporters is set at a mean score of 4 or greater.",{"measure":72,"description":73,"timeFrame":74},"Treatment Engagement","Number of treatment sessions completed at post-treatment, compared to prescribed or recommended number of sessions","From enrollment to post-treatment at 8 weeks",{"measure":76,"description":77,"timeFrame":78},"Readmission\u002FAdmission Rates","Readmission\u002Fadmission rates to the psychiatric ED or inpatient psychiatric hospitalization will be evaluated via caregiver report on the Brief form of the Services Assessment for Children and Adolescents (SACA; Horwitz et al., 2001), which will be supplemented with chart review.","From enrollment to 3-month follow-up at 8 weeks",{"measure":80,"description":81,"timeFrame":82},"Feasibility of Measurement","% participants at each timepoint completing measures (target = ≥ 80% at each timepoint).","From enrollment to follow-up at 20 weeks",{"measure":84,"description":85,"timeFrame":57},"Non-Suicidal Self-Injury","Measured using an adapted version of the Self-Injurious Thoughts and Behaviors Interview (SITBI)-Short Form, Thoughts of NSSI and NSSI subscales (Nock et al., 2007), which assesses history and characteristics of NSSI thoughts and behaviors. First instance of engagement in NSSI after beginning treatment will be the outcome of most interest, but other outcomes assessed by the interview (e.g., frequency of NSSI thoughts) may be examined as well if rates of NSSI are very low.","ALL","7 Years","12 Years",false,{"inclusion":91,"exclusion":98,"raw_text":104},[92,93,94,95,96,97],"between the ages of 7-12","at least one caregiver\u002Flegal guardian able to participate (more permitted)","experienced at least one episode of SITBs within the last month","ability to attend weekly sessions in-person or via telehealth","ability to attend baseline and post-treatment assessments in-person.","estimated verbal IQ of 70 or greater",[99,100,101,102,103],"symptoms interfering with ability to participate in assessments\u002Ftherapy (i.e., psychosis)","estimated verbal IQ\\\u003C70 or previous diagnosis of intellectual development disorder","requiring inpatient psychiatric stabilization or high-intensity intervention to prevent hospitalization","active substance use","ward of the state","Inclusion Criteria:\n\n* between the ages of 7-12\n* at least one caregiver\u002Flegal guardian able to participate (more permitted)\n* experienced at least one episode of SITBs within the last month\n* ability to attend weekly sessions in-person or via telehealth\n* ability to attend baseline and post-treatment assessments in-person.\n* estimated verbal IQ of 70 or greater\n\nExclusion Criteria\n\n* symptoms interfering with ability to participate in assessments\u002Ftherapy (i.e., psychosis)\n* estimated verbal IQ\\\u003C70 or previous diagnosis of intellectual development disorder\n* requiring inpatient psychiatric stabilization or high-intensity intervention to prevent hospitalization\n* active substance use\n* ward of the state",[106],"CHILD",[108],{"facility":109,"city":110,"state":111,"zip":112,"country":113,"contacts":114,"geoPoint":123},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",[115,120],{"name":116,"role":117,"phone":118,"email":119},"Sarah Kennedy, PhD","CONTACT","303-724-6458","sarah.kennedy@cuanschutz.edu",{"name":121,"role":122},"Sarah M Kennedy, PhD","PRINCIPAL_INVESTIGATOR",{"lat":124,"lon":125},39.72943,-104.83192,[],[],[],[],{"nct_id":4,"conditions":131,"biomarkers":134},[132,22,133,20],"Dysexecutive function","Self-Injurious Thoughts and Behaviors",[],{"nct_id":4,"found":15,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This study is an interventional, quasi-experimental design involving 52 preadolescents. It will compare a new intervention to standard care.","completed","Study of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors in Children","This study is developing and testing a new outpatient intervention called \"Preadolescent SITB Intervention\" for children aged 7-12 who experience self-injurious thoughts and behaviors (SITBs). The goal is to see if this new intervention, which focuses on emotion regulation and executive functioning (mental skills like planning and problem-solving), is practical and helpful. The study will first observe children receiving typical care (Treatment as Usual, TAU) and then introduce the new intervention. Researchers want to know if the study design works, if the new intervention is acceptable, and if it leads to better outcomes for SITBs and mental health compared to TAU. The study plans to enroll 52 children and their caregivers.","Not specified.",111,"Participants will attend weekly sessions, either in-person or via telehealth, and complete baseline and post-treatment assessments in-person. The study involves two phases, lasting a total of 13 months.","Not stated in the trial record.",[45],"v2"]