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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.

Study design
This study is an interventional, quasi-experimental design involving 52 preadolescents. It will compare a new intervention to standard care.
What's involved
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.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07281365

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

Not Yet Recruiting
NAAges 7–12InterventionalTreatment
University of Colorado, Denver
~52 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Treatment as usual (TAU)Preadolescent SITB Intervention

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of recruitment
Measured over Calculated at enrollment

Conditions

Self-injury
Suicidal Ideation and Behavior
Executive Functioning
Emotion Regulation

Explore related trials

Dysexecutive functionEmotion RegulationSelf-Injurious Thoughts and BehaviorsSuicidal Ideation and Behavior

Where it's being run

1 sites across 1 states
Colorado1

Who to contact

Sarah Kennedy, PhD
[email protected]
303-724-6458
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
ability to attend baseline and post-treatment assessments in-person.
estimated verbal IQ of 70 or greater

Exclusion

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
ward of the state

What this trial measures

  • Feasibility of recruitmentCalculated at enrollment

    % recruitment targets met (benchmark = 52 preadolescents enrolled within 13 months)