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Pilotforsøg med en intervention for følelsesregulering og eksekutive funktioner til selvskadende tanker og adfærd (SITB) hos børn

27. juli 2026 opdateret af: University of Colorado, Denver

Proof-of-Concept-forsøg af en intervention for følelsesregulering og eksekutive funktioner for SITB'er hos børn

Formålet med denne undersøgelse er at udvikle og teste en ambulant intervention for børn i skolealderen (7-12 år) med selvskadende tanker og adfærd (SITB).

De vigtigste spørgsmål, den sigter efter at besvare, er:

  1. Fører den nyere intervention til bedre engagement af familier i behandlingen sammenlignet med sædvanlig behandling (TAU)?
  2. Er den nye intervention gennemførlig, acceptabel og passende?
  3. Fører den nye intervention til større forbedringer i SITB, psykiske symptomer og behandlingsmål sammenlignet med TAU?

Deltagende børn i skolealderen med SITB og deres familier vil blive randomiseret til enten den nye intervention eller TAU, som vil bestå af de typiske interventioner, som studietterapeuten ville bruge for børn i skolealderen med SITB. Deltagerne vil:

  1. Udføre en indledende baselinevurdering for at fastslå berettigelse og vurdere SITB, psykiske symptomer, eksekutive funktioner og følelsesregulering
  2. Deltage i en ambulant intervention, der foregår ca. ugentligt og varer omkring 3-4 måneder
  3. Udføre yderligere vurderinger midt i behandlingen, efter behandlingen og efter 3 måneders opfølgning
  4. Deltage i et interview, hvor de deler deres opfattelse af interventionen

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

I fase 1 af undersøgelsen (Formål 1) vil forskerne iterativt designe en intervention for præadolescente SITB'er gennem en trin-for-trin proces ved hjælp af rammer til systematisk udvikling og tilpasning af interventioner (Wingood et al., 2008; Bartholomew et al., 1998). Designprocessen vil inkorporere brugercentrerede designmetoder, hvorved tverrsektorielle eksperter og slutbrugere (dvs. terapeuter og familier) vil deltage i designprocessen for at maksimere interventionens sprednings- og implementeringspotentiale. I fase 2 af undersøgelsen (Formål 2 og 3) vil forskerne udføre et pilotrandomiseret kontrolleret forsøg (RCT) af interventionen med en behandling som sædvanlig (TAU) som komparator hos 52 præadolescente i alderen 7-12 år. Formål 2 vil evaluere engagement (primært udfald), gennemførlighed, acceptabilitet og implementeringsresultater for interventionen og studieprocedurerne. Formål 3 vil være at indsamle foreløbige beviser for at undersøge overlegenheden af SITB-interventionen i forhold til TU ved reduktion af SITB'er og engagement af de målrettede mekanismer for EF og følelsesregulering.

I fase 1 vil forskerne anvende mixed methods-tilgange og brugercentrerede designprincipper til iterativt at udvikle den præadolescente SITB-intervention. Gennem en behovsvurdering vil forskerne anvende et eksplorativt sekventielt kvalitativt → kvantitativt mixed methods-design, hvorved kvalitative interviews med terapeuter vil informere udviklingen af en kvantitativ spørgeskemaundersøgelse, der vurderer behov og erfaringer hos terapeuter, der behandler præadolescente med SITB'er. Resultater fra terapeutvurderingen vil blive integreret med resultater fra kvalitative interviews med præadolescente og omsorgspersoner for yderligere at informere indledende beslutninger om kernefunktioner og specifikke komponenter i interventionen. I en fortestningsfase, der anvender en samtidig mixed methods-tilgang, vil terapeuter og præadolescente/familier deltage i think-aloud designsessioner for at give kvantitativ og kvalitativ feedback om grove interventionsprototyper. En indledende udkastversion af interventionen vil derefter blive produceret og gennemgået af en gruppe eksperter, hvilket resulterer i et andet udkast af interventionen samt terapeuttrænings- og konsultationsprocedurer. Et enarms pilotgennemførlighedsforsøg af interventionen med 9 præadolescente (ADAPT-ITT Trin 8, Del 1) vil informere tilpasninger af interventionen, terapeuttræning og forsøgsprocedurer.

Fase 2 vil omfatte træning af terapeuter i interventionen ved hjælp af procedurer og materialer forfinet under pilotforsøget, efterfulgt af et RCT med en TAU-kontrolbetingelse med 52 præadolescente (ADAPT-ITT Trin 8, Del 2). Forsøget vil være dimensioneret til at påvise forskelle i engagement mellem betingelserne (primært udfald) og etablere gennemførlighed og acceptabilitet, samtidig med at det evaluerer foreløbige effektresultater og EF-ændringsmekanismer.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Children's Hospital Colorado
        • Kontakt:
        • Ledende efterforsker:
          • Sarah M Kennedy, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • i alderen 7-12 år
  • mindst én omsorgsperson/legal værge i stand til at deltage (flere tilladt)
  • oplevet mindst én episode af SITBs inden for den sidste måned
  • i stand til at deltage i ugentlige sessioner personligt eller via fjernkonsultation
  • i stand til at deltage i baseline- og 12-ugers vurderinger personligt
  • estimeret verbal IQ på 70 eller højere

Eksklusionskriterier

  • symptomer, der forstyrrer evnen til at deltage i vurderinger/terapi (dvs. psykose)
  • estimeret verbal IQ<70 eller tidligere diagnose af intellektuel udviklingsforstyrrelse
  • kræver indlæggelse til psykiatrisk stabilisering eller højintensiv intervention for at forhindre hospitalsindlæggelse
  • aktivt stofmisbrug
  • under statens værge

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Preadolescent SITB Intervention
Eksperimentel intervention for præadolescente SITB'er, der retter sig mod eksekutive funktioner, følelsesregulering og andre SITB-risikofaktorer
Adfærdsmæssigt: Preadolescent SITB Intervention
Eksperimentel intervention udviklet med slutbrugere og eksperter for at målrette følelsesregulering, eksekutive funktioner og andre risikofaktorer for SITB'er hos præadolescenter
Aktiv komparator: Behandling som sædvanlig (TAU)
Behandling som sædvanligt leveret af ambulant mental sundhedsterapeut
Adfærdsmæssigt: Sædvanlig behandling (TAU)
Typiske interventioner en ambulatorisk terapeut vil tilbyde en præadolescent med SITBs baseret på deres kliniske vurdering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of recruitment
Tidsramme: Calculated at enrollment
% recruitment targets met (benchmark = 52 preadolescents enrolled within 13 months)
Calculated at enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Suicidal Ideation Intensity
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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
Feasibility of Retention
Tidsramme: From enrollment to the end of treatment at 8 weeks
% participants completing treatment (benchmark =≥ 80% participants considered treatment completers)
From enrollment to the end of treatment at 8 weeks
Perceived Appropriateness of Intervention
Tidsramme: From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
Perceived Feasibility of Intervention
Tidsramme: From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
Perceived acceptability of intervention
Tidsramme: From enrollment to the end of treatment at 8 weeks
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.
From enrollment to the end of treatment at 8 weeks
Treatment Engagement
Tidsramme: From enrollment to post-treatment at 8 weeks
Number of treatment sessions completed at post-treatment, compared to prescribed or recommended number of sessions
From enrollment to post-treatment at 8 weeks
Readmission/Admission Rates
Tidsramme: From enrollment to 3-month follow-up at 8 weeks
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.
From enrollment to 3-month follow-up at 8 weeks
Feasibility of Measurement
Tidsramme: From enrollment to follow-up at 20 weeks
% participants at each timepoint completing measures (target = ≥ 80% at each timepoint).
From enrollment to follow-up at 20 weeks
Non-Suicidal Self-Injury
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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.
From enrollment to 3-month follow-up at 20 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anxiety Symptoms
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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).
From enrollment to 3-month follow-up at 20 weeks
Depression Symptoms
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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).
From enrollment to 3-month follow-up at 20 weeks
Disruptive Behavior Symptoms
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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.
From enrollment to 3-month follow-up at 20 weeks
Emotion Dysregulation--Reactivity
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
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.
From enrollment to 3-month follow-up at 20 weeks
Emotion Dysregulation--Dysphoria
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
Measured using the Emotion Dysregulation Inventory-Dysphoria Short Form (EDI-D; Mazefsky et al., 2018; 2021), which is a 6-item, caregiver report measure of dysphoria in youth. Items are rated on a 5-point Likert scale, with higher scores indicating greater dysphoria.
From enrollment to 3-month follow-up at 20 weeks
Caregiver Report of Preadolescent Executive Functioning
Tidsramme: From enrollment to 3-month follow-up at 20 weeks
The Brief Rating Inventory of Executive Function 2nd Edition (BRIEF 2) --Parent Form (Gioia et al., 2015) is 63-item questionnaire with eight clinical scales designed to assess everyday behaviors associated with seven domains of EF. These scales are combined to form two broader indices (Behavioral Regulation and Metacognition) and a Global Executive Composite score. Items are rated on a 4-point scale, and sum scores for each scale and index are converted to t-scores, with higher t-scores indicating greater difficulties with executive functioning. The measure has strong psychometric properties, discriminates between typically developing and clinical populations, and is sensitive to change.
From enrollment to 3-month follow-up at 20 weeks
Behavioral Assessment of Executive Functioning and Distress Tolerance
Tidsramme: From enrollment through post-treatment at 8 weeks
Executive Function Challenge Task (EFCT; Kenworthy et al., 2014, 2020) is a "hot" measure of EF that uses a standardized protocol to assess flexibility and planning during several activities with an examiner that change rules or modalities. The EFCT has precise behavioral markers to guide scoring on a three-point scale and yields flexibility and planning raw scores that range from 0 to 8. The EFCT has good psychometric properties and demonstrated moderate associations with parent-reported EF and treatment-specific sensitivity to change (Kenworth et al., 2014; 2020).
From enrollment through post-treatment at 8 weeks
Task-Based Assessment of Executive Functioning
Tidsramme: From enrollment to the end of treatment at 8 weeks
NIH toolbox Dimensional Change Card Sort test (DCCS; Kavanaugh et al., 2020; Zelazo et al., 2013). is a standard, lab-based, computerized task for assessing cognitive flexibility, will be administered as a computerized measure of EF. The DCCS has been validated in youth, does not demonstrate practice effects, and has excellent convergent validity.
From enrollment to the end of treatment at 8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Colorado, Denver

Samarbejdspartnere

National Institute of Mental Health (NIMH)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

1. december 2025

Først indsendt, der opfyldte QC-kriterier

11. december 2025

Først opslået (Faktiske)

15. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24-1783
  • R34MH135963 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD fra det randomiserede, kontrollerede forsøg vil blive delt med NIMH National Data Archive.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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