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Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study

Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07717190
Enrollment
55
Registered
2026-07-21
Start date
2025-09-01
Completion date
2026-09-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Effect, Fetal Alcohol Syndrome, Fetal Alcohol Syndrome Disorders

Keywords

Dog-assisted therapy, Fetal alcohol spectrum disorder L, ongitudinal follow-up, Child and adolescent mental health, Caregivers' emotional well-being.

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALDog assisted therapy

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.

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

This study follows a cohort of children and adolescents with fetal alcohol spectrum disorder who have previously completed dog-assisted therapy. Outcomes are assessed at multiple follow-up time points to determine whether the therapeutic benefits remain stable over time. The study also considers caregiver emotional well-being and potential external factors that may influence long-term outcomes.

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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. \-

Exclusion criteria

Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded. \-

Design outcomes

Primary

MeasureTime frameDescription
Wechsler Intelligence Scale for ChildrenSingle administration baselineIntellectual Quotient
Child Behavior Checklist (CBCL by Achenbach)3, 6 and 12 months after baselineInternalizing/ Externalizing Symptoms maximum scores for symptom severity
Social Skills Improvement System-Parent Form (SSIS-P)3, 6 and 12 months after baselineSocial skills assessment - 0 to 60 max scotring
KidScreen 27- 0 maximum 135 - highest severity symptoms at 1353, 6 and 12 months after baselineQuality of life assesment
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).3,6 and 12 months after baselineSeverity of FASD symptoms

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026