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Dialectic Behaviour Therapy (DBT) for People With Autism: A Multiple Baseline Single Case Design (DGT-ASS)

25. august 2026 oppdatert av: GGZ Friesland

Dialectic Behaviour Therapy (DBT) for People With Autism, Emotion Regulation Difficulties and Self-harm Behaviour: A Multiple Baseline Single Case Design

The goal of this experimental study is to test the effectiveness of Dialectic Behavioural Therapy in patients with Autism Spectrum Disorder. The aim questions are:

  1. What is the effect of DBT on maladaptive emotion regulation strategies and emotional well-being in patients with ASD?
  2. Is the use of DBT skills associated with a reduction in maladaptive emotion regulation strategies and an increase of emotional well-being over time?
  3. What are the dynamics over time between maladaptive emotion regulation strategies, emotional well-being and sensory overload?

Participants will:

  • Follow DBT of 10 months
  • Keep a diary on their urge of maladaptive emotion regulation strategies and well-being

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

6

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Nederland
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Nederland, 8934AD
        • Rekruttering
        • GGZ Friesland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • DSM-5 diagnosis of ASD
  • Sufficient understanding, as demonstrated in conversation with intake therapist;
  • Explicit behavioural problems, which, according to patient and therapist, lead to functional problems (like suicidal ideation, auto mutilation, emotional outburst and interpersonal conflicts);
  • BMI > 17;
  • Commitment to the therapy and shared goals as assessed by intake therapist;

Exclusion Criteria:

  • Antisocial behaviour which interrupts the group climate;
  • Presence of a trauma-related disorder that is likely to interfere with the ability to engage effectively in DBT or that requires specialized trauma-focused treatment prior to or alongside DBT as assessed by intake team;
  • Excessive dependency on substances for which no parallel appropriate policy can be made;
  • Diagnosis of psychotic disorder if not stable;
  • Diagnosed with bipolar disorder.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dialectic Behavioural Therapy
Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder, given for 10 months
Atferdsmessig: Dialectic Behavioural Therapy
Dialectic Behavioural Therapy for emotion regulation, adapted to individuals with Autism Spectrum Disorder

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maladaptive Emotion Regulation Strategies (MERS) measured assessed by the DBT diary (Linehan, 2016)
Tidsramme: From enrollment to end of treatment at 10 months

MERS is the average of the urge to six maladaptive emotion regulation strategies:

  1. suicidal thoughts/behaviours
  2. self-harm,
  3. eating problems
  4. substance abuse
  5. anger outburst
  6. other All emotion regulation strategies are measured on a scale from 0 - 100. MERS will be created by adding scores of the six strategies together and divide it by 6.
From enrollment to end of treatment at 10 months
Emotional well-being as assessed by the DBT diary (Linehan, 2016)
Tidsramme: From enrollment to end of treatment at 10 months
The daily diary measures emotional suffering and happiness on a scale from 0 - 100. Emotional suffering is inverted, following the logic that higher emotional suffering means lower emotional well-being. The variable well-being is created by averaging the invert of emotional suffering and happiness.
From enrollment to end of treatment at 10 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Social behaviour
Tidsramme: At start of baseline (T1), at end of treatment phase at 10 months (T2)
As measured by the Vragenlijst Inventarisatie van Sociaal gedrag bij Volwassenen (VIS-V) (Horwitz et al. 2013). The VIS-V is a 44-item questionnaire that assess social behaviour, with answers ranging from 0 (= not applicable) to 2 (=cleary applicable). Higher scores mean lower social behaviour.
At start of baseline (T1), at end of treatment phase at 10 months (T2)
Emotion regulation
Tidsramme: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
As measured with the Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer, 2004). The DERS is a 36-item questionnaire with 5-point Likert answers, ranging from "almost never" to "almost always".
At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
Generic psychopathology and functioning
Tidsramme: At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)
As measured with the Outcome Questionnaire-45 (OQ-45) (De Jong et al., 2008). The OQ-45 is a 45-item questionnaire, with answers ranging from never (0) to almost always (4). Some items are mirrored.
At the start of the baseline phase (T1), at the end of the treatment phase at 10 months (T2)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GGZ Friesland

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2027

Studiet fullført (Antatt)

1. februar 2028

Datoer for studieregistrering

Først innsendt

12. august 2026

Først innsendt som oppfylte QC-kriteriene

25. august 2026

Først lagt ut (Faktiske)

26. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025/666

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

To protect the participants of the study

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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