Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorUniversity of Colorado, Denver

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Treatment as usual (TAU)
  • Preadolescent SITB Intervention

Treatment groups

52 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator