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Behavioral Activation for Treatment of Depression in Autistic Adolescents With Below Average Intelligence

4. september 2026 opdateret af: Michelle Menezes, Stony Brook University
Autism spectrum disorder is characterized by differences in social communication/interaction and the presence of restricted/repetitive behaviors, with significant heterogeneity in terms of autistic features, language ability, and cognitive characteristics. About 2-3% of individuals in the United States are autistic, and most autistic individuals have co-occurring mental health conditions. Autistic people are 3-4 times more likely to experience depression than non-autistic people. Of the emerging depression treatment research with autistic people, none to date has focused on developing and testing a depression treatment for autistic youth with below average cognitive abilities - a group which comprises over 50% of the autistic community. Therefore, this study seeks to evaluate the feasibility (Aim 1), acceptability (Aim 2), and preliminary treatment effects (Aim 3) of an extension of Behavioral Activation for Depression in Autistic Adolescents (BA-A), adapted to meet the needs of cognitively lower functioning autistic youth.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

Inclusion Criteria

  • 12-17 years old
  • Autism diagnosis
  • Symptoms of depression (more specifically, Children's Depression Inventory, Second Edition parent-report and/or self-report T-score ⩾ 65)
  • IQ 60-84
  • Stable on medications for mood, anxiety, and/or behavior for 3 months
  • Participation of same parent(s) in all therapy sessions and assessment visits Exclusion Criteria
  • Participation in another psychotherapy during the study period
  • Imminent risk of harm to self and/or others
  • Bipolar disorder, a personality disorder, and/or schizophrenia or another psychotic disorder

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BA-A
BA-A is an individually delivered manualized 12-session treatment that utilizes established behavioral strategies and incorporates common mental health treatment adaptations for autistic young people.
Adfærdsmæssigt: BA-A
BA-A is an individually delivered manualized 12-session treatment that utilizes established behavioral strategies and incorporates common mental health treatment adaptations for autistic young people.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Children's Depression Rating Scale, Revised
Tidsramme: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Children's Depression Inventory, Second Edition
Tidsramme: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Aberrant Behavior Checklist
Tidsramme: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Behavioral Activation for Depression Scale-Short Form
Tidsramme: Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Baseline, Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline]), 1-Month Follow-Up (1 month following completion of therapy sessions)
Acceptability of Intervention Measure
Tidsramme: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Intervention Appropriateness Measure
Tidsramme: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Feasibility of Intervention Measure
Tidsramme: Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])
Post-Treatment (i.e., after completion of 12 weekly therapy sessions [typically 12-13 weeks after baseline])

Samarbejdspartnere og efterforskere

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

Sponsor

Stony Brook University

Efterforskere

  • Ledende efterforsker: Michelle Menezes, PhD, Stony Brook University

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 (Faktiske)

10. august 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

31. august 2026

Først indsendt, der opfyldte QC-kriterier

4. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB2026-00072

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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