Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study
16. juli 2026 opdateret af: Hospital Universitari Vall d'Hebron Research Institute
This study looks at whether dog-assisted therapy helps children and adolescents with fetal alcohol spectrum disorder improve social skills, behavior, quality of life, and emotional well-being, and whether these benefits last over time.
It is also aimed at assessing caregivers' emotional well-being.
Participants will already have completed the therapy, and the study will follow them at different time points to see if the changes remain months later.
Families and health care providers should know that the evaluation uses standard questionnaires and clinical ratings, with no new invasive procedures, and the main goal is to better understand which children and families benefit most and how to make this type of therapy more effective in routine care.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Detaljeret beskrivelse
This longitudinal study evaluates whether the benefits of dog-assisted therapy in children and adolescents with fetal alcohol spectrum disorder are maintained over time.
The project focuses on social functioning, behavior, quality of life, clinical severity, and the emotional well-being of caregivers, using repeated follow-up assessments after treatment.
The aim is to determine the durability of the intervention effects and identify factors that may influence long-term outcomes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
55
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Barcelona
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Barcelona, Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron, Barcelona, Barcelona 08035
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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
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
inclusion Criteria:all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.
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Exclusion Criteria:Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Long-term Follow-up of Dog-Assisted Therapy.
This arm includes children and adolescents with fetal alcohol spectrum disorder who have previously completed a structured dog-assisted therapy program.
Participants are followed at later time points to assess whether improvements in social skills, behavior, quality of life, and caregiver emotional well-being are maintained over time.
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The intervention consists of a structured dog-assisted therapy program previously delivered to children and adolescents with fetal alcohol spectrum disorder in the clinical setting.
It is distinguished by the active involvement of a trained therapy dog as part of the therapeutic process, with sessions designed to promote social interaction, emotional regulation, behavioral engagement, and communication.
The present study does not introduce a new intervention; rather, it evaluates the persistence of the effects produced by this specific dog-assisted therapy program over time.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Wechsler Intelligence Scale for Children
Tidsramme: Single administration baseline
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Intellectual Quotient
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Single administration baseline
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Child Behavior Checklist (CBCL by Achenbach)
Tidsramme: 3, 6 and 12 months after baseline
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Internalizing/ Externalizing Symptoms maximum scores for symptom severity
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3, 6 and 12 months after baseline
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Social Skills Improvement System-Parent Form (SSIS-P)
Tidsramme: 3, 6 and 12 months after baseline
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Social skills assessment - 0 to 60 max scotring
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3, 6 and 12 months after baseline
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KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Tidsramme: 3, 6 and 12 months after baseline
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Quality of life assesment
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3, 6 and 12 months after baseline
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Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Tidsramme: 3,6 and 12 months after baseline
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Severity of FASD symptoms
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3,6 and 12 months after baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
1. september 2025
Primær færdiggørelse (Anslået)
1. september 2026
Studieafslutning (Anslået)
1. september 2026
Datoer for studieregistrering
Først indsendt
16. juli 2026
Først indsendt, der opfyldte QC-kriterier
16. juli 2026
Først opslået (Faktiske)
21. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Graviditetskomplikationer
- Fostersygdomme
- Stof-relaterede lidelser
- Kemisk inducerede lidelser
- Alkohol-relaterede lidelser
- Alkohol-inducerede lidelser
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Føtale alkoholspektrumforstyrrelser
Andre undersøgelses-id-numre
- PR(AG)229-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
IPD-planbeskrivelse
The data collected from the patients evaluated in our hospital will be stored in the medical records of Vall d'Hebron University Hospital, as well as in a computerized database that allows for analysis.
Rigorous confidentiality of the data will be maintained in accordance with current regulations in Spain (Ley Orgánica de Protección de Datos).
To analyze the final data from the three hospitals, each patient will be coded (anonymous code) to facilitate data processing.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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