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

NCT07717190 | Active Not Recruiting

• 1 other identifier: PR(AG)229-2026
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (5)

• Wechsler Intelligence Scale for Children

  Intellectual Quotient

  Single administration baseline

• Child Behavior Checklist (CBCL by Achenbach)

  Internalizing/ Externalizing Symptoms maximum scores for symptom severity

  3, 6 and 12 months after baseline

• Social Skills Improvement System-Parent Form (SSIS-P)

  Social skills assessment - 0 to 60 max scotring

  3, 6 and 12 months after baseline

• KidScreen 27- 0 maximum 135 - highest severity symptoms at 135

  Quality of life assesment

  3, 6 and 12 months after baseline

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

  Severity of FASD symptoms

  3,6 and 12 months after baseline

Study Arms (1)

Long-term Follow-up of Dog-Assisted Therapy.

OTHER

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.

Behavioral: Dog assisted therapy

Interventions

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.

Also known as: DAT

Long-term Follow-up of Dog-Assisted Therapy.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron, Barcelona, Barcelona 08035

Barcelona, Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

ES (1)