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NCT Number: NCT07717190

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Fetal Alcohol Effect Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Fetal Alcohol Syndrome Disorders Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona 08035

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Dog assisted therapy

Behavioral

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.

Other names: DAT

Primary outcomes

  1. Wechsler Intelligence Scale for Children

    Time frame: Single administration baseline

    Intellectual Quotient

  2. Child Behavior Checklist (CBCL by Achenbach)

    Time frame: 3, 6 and 12 months after baseline

    Internalizing/ Externalizing Symptoms maximum scores for symptom severity

  3. Social Skills Improvement System-Parent Form (SSIS-P)

    Time frame: 3, 6 and 12 months after baseline

    Social skills assessment - 0 to 60 max scotring

  4. KidScreen 27- 0 maximum 135 - highest severity symptoms at 135

    Time frame: 3, 6 and 12 months after baseline

    Quality of life assesment

  5. Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).

    Time frame: 3,6 and 12 months after baseline

    Severity of FASD symptoms

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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