- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07624448
Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)
Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability
The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:
To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Up to ten children with autism and co-occurring Intellectual Disability (ASD + ID) ages 8 to 12 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help children with ASD + ID calm their emotions. Participants will complete assessments at five time points:
Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Grayson Manley, RN
- Telefonnummer: 816-816-6967
- E-mail: gmanley@cmh.edu
Studiesteder
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Rekruttering
- Children's Mercy
-
Kontakt:
- Grayson Manley, RN
- Telefonnummer: 816-816-6967
- E-mail: gmanley@cmh.edu
-
Ledende efterforsker:
- Walker McKinney, PhD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Child Participant Inclusion Criteria:
- Males, females, or non-binary youth between 8 and 12 years of age
- Confirmed diagnosis of Autism Spectrum Disorder (ASD)
- Confirmed diagnosis of Intellectual Disability
- Fluent in spoken English.
- Use of flexible phrase speech or greater
- Meeting clinically significant emotion dysregulation criteria
- Willing to participate in twice weekly 90-minute sessions
- Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
- Parent, guardian, or legally authorized representative (LAR) must provide written permission on behalf of the participant
Child Participant Exclusion Criteria:
- Initiation of new psychosocial intervention within 30 days prior to first day of treatment
- Presence of physical aggression in the child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.
- Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
- Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Caregiver Inclusion Criteria:
- Age ≥ 18 years
- Lives and cares for their child with ASD+ID for > 50% of the year
- Fluent in spoken English.
- Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Studieplan
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: Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
|
Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions.
This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Autism with a co-occurring intellectual disability.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Emotion Dysregulation Inventory - Reactivity
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
The Emotion Dysregulation Inventory consists of two subscales.
The investigators will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation.
Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinician Global Impressions - Improvement (CGI-I)
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A trained, independent clinician will rate the CGI at T3 and T5.
The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Emotion Regulation Skills Test
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Caregiver-report measures to measure change in internalizing symptoms.
For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Aberrant Behavior Checklist, 2nd Edition (ABC-2)
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors.
Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Parenting Stress Index, 4th Edition, Short Form
Tidsramme: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system.
Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress
|
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
|
Caregiver and Child Readiness and Satisfaction Surveys
Tidsramme: From enrollment to end of follow up at 15 weeks
|
The investigators will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures.
Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.
|
From enrollment to end of follow up at 15 weeks
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Walker McKinney, PhD, Children's Mercy
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Autismespektrumforstyrrelse
- Afvigende motorisk adfærd ved demens
- Neurologiske manifestationer
- Sygdomme i nervesystemet
- Psykiske lidelser
- Adfærdsmæssige symptomer
- Neuroadfærdsmæssige manifestationer
- Neuroudviklingsforstyrrelser
- Børns udviklingsforstyrrelser, gennemgående
- Patologiske tilstande, tegn og symptomer
- Opførsel
- Tegn og symptomer
- Social adfærd
- Autistisk lidelse
- Intellektuel handicap
- Aggression
Andre undersøgelses-id-numre
- STUDY00004069
- KL2TR002367 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med Intellektuel handicap
-
Assistance Publique - Hôpitaux de ParisPlateforme PRISMEAfsluttet
-
Simons SearchlightBoston Children's Hospital; Geisinger Clinic; Simons FoundationRekrutteringSMARCA4 genmutation | DDX3X | 16P11.2 Deletionssyndrom | 16p11.2 Duplikationer | 1Q21.1 Sletning | 1Q21.1 mikroduplikationssyndrom (lidelse) | ACTL6B | ADNP | AHDC1 | ANK2 | ANKRD11 | ARID1B | ASH1L | BCL11A | CHAMP1 | CHD2 | CHD8 | CSNK2A1 | CTBP1 | CTNNB1-genmutation | CUL3 | DNMT3A | DSCAM | DYRK1A | FOXP1 | GRIN2A | GRIN2B | HIVEP2-relateret intellektuel... og andre forholdForenede Stater
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins... og andre samarbejdspartnereRekrutteringMitokondrielle sygdomme | Retinitis Pigmentosa | Myasthenia gravis | Eosinofil gastroenteritis | Moyamoyas sygdom | Multipel systematrofi | Leiomyosarkom | Leukodystrofi | Anal fistel | Spinocerebellar ataksi type 3 | Friedreich Ataxia | Kennedys sygdom | Lyme sygdom | Hæmofagocytisk lymfohistiocytose | Spinocerebellar ataksi... og andre forholdForenede Stater, Australien
Kliniske forsøg med Regulating Together group therapy
-
Corewell Health EastAfsluttetUrinblære, overaktiv | Ufrivillig vandladning | Urinvejsinfektioner | Stressurininkontinens | Dyspareuni | Menopause relaterede tilstande | Genitourinary System; Lidelse, kvinde | Brændende skede | Irritation; VaginaForenede Stater
-
Superior UniversityAfsluttet
-
Karolinska InstitutetAfsluttetBorderline personlighedsforstyrrelse | Ikke-suicidal selvskade (NSSI)Sverige
-
Karadeniz Technical UniversityAfsluttetHæmodialyse | Ensomhed | Lykke | Tilpasning | Dyreassisteret terapi | SymptomKalkun
-
The University of Hong KongHong Chi AssociationAfsluttetIntellektuel handicap | Mor-barn forholdHong Kong
-
Ain Shams UniversityFayoum UniversityAktiv, ikke rekrutterendeTandudtrækning | Øjeblikkeligt tandimplantat | Klasse II udsugningsstik | Estetisk zone implantologiEgypten
-
Hackensack Meridian HealthAmerican Music Therapy AssociationAfsluttetSkizofrenispektrum og andre psykotiske lidelser | Maniodepressiv | Angst lidelse | Psykiske problemer | DepressivForenede Stater
-
Murdoch Childrens Research InstituteRekrutteringVelvære | Angst | Psykisk nød | Depression i ungdomsårene | Mestring | Minoritetsstress | Acceptabilitet | Stolthed | Internaliseret stigma | Community ConnectionAustralien
-
Charite University, Berlin, GermanyLudwig-Maximilians - University of Munich; Bogomolets National Medical...RekrutteringDepression NOSUkraine
-
National Taiwan University HospitalRekrutteringOsteoporose | Osteoporose PostmenopausalTaiwan