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).
The main questions it aims to answer are:
1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU?
Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will:
1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in a \~weekly, outpatient intervention lasting around 3-4 months 3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention
between the ages of 7-12
at least one caregiver/legal 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
symptoms interfering with ability to participate in assessments/therapy (i.e., psychosis)
estimated verbal IQ<70 or previous diagnosis of intellectual development disorder
requiring inpatient psychiatric stabilization or high-intensity intervention to prevent hospitalization
active substance use
Parallel
Treatment as usual (TAU)
BehavioralTypical interventions Outpatient therapist would provide to a preadolescent with SITBs, based on their clinical judgement
Preadolescent SITB Intervention
BehavioralExperimental intervention developed with end-users and experts to target emotion regulation, executive functioning, and other risk factors for SITBs in preadolescents
Treatment Engagement
Number of treatment sessions completed at post-treatment
Feasibility of Retention
% participants completing treatment (benchmark =≥ 80% participants considered treatment completers)
Feasibility of recruitment
% recruitment targets met (benchmark = 52 preadolescents randomized to receive treatment)
Feasibility of Measurement
% participants at each timepoint completing measures (target = ≥ 80% at each timepoint).
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.
Readmission/Admission Rates
Readmission/admission 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.
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.
Anxiety Symptoms
We will measure anxiety using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of anxiety symptoms. Anxiety items are summed to yield a raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
Depression Symptoms
We will measure depression using the Revised Child Anxiety and Depression Scale (RCADS)-Short Version (Ebesutani et al., 2012; 2017), which is a 25-item measure of depression and anxiety symptoms that includes both parent-and self-report measures. Both versions are rated on a 5-point Likert scale, with higher scores indicating greater frequency of depression symptoms. Depression items are summed to yield a total raw score, which is then converted to a t-score. The measure has good psychometric properties and treatment sensitivity (Ebesutani et al., 2012; 2017).
Disruptive Behavior Symptoms
We will measure disruptive behaviors using the Disruptive Behavior Disorders Scale (DBRS)-Parent Version (Fosco et al., 2023), a 45-item rating scale used to assess symptoms of inattention, hyperactivity-impulsivity, and oppositional defiant behavior among school-aged children. Items are rated on a 4-point scale, with higher scores indicating greater severity of symptoms.
Emotion Dysregulation--Reactivity
Measured using the Emotion Dysregulation Inventory-Reactivity Short Form (EDI-R; Mazefsky et al., 2018; 2021), which includes a 7-item, caregiver report measure of emotional reactivity. Items are rated on a 5-point Likert scale, with higher scores indicating greater emotional reactivity.
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University of Colorado, Denver
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
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