Active — Not RecruitingNot Applicable

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

Spain55 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wechsler Intelligence Scale for Children

Timeframe: Single administration baseline

Child Behavior Checklist (CBCL by Achenbach)

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3,6 and 12 months after baseline

Trial details

NCT IDNCT07717190

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Fetal Alcohol Effect trials

Plain-language summary

Who can participate

Age range

6 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wechsler Intelligence Scale for Children

Timeframe: Single administration baseline

Child Behavior Checklist (CBCL by Achenbach)

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3, 6 and 12 months after baseline

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

Timeframe: 3,6 and 12 months after baseline