CompletedNot Applicable

Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder

Spain55 participantsStarted 2022-02-20

Plain-language summary

The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.

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: Once- Pre intervention week 1 - Post intervention in week 16

Child Behavior Checklist (CBCL by Achenbach)

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

Trial details

NCT IDNCT06763614

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-20

View on ClinicalTrials.gov More Fetal Alcohol Spectrum Disorders 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: Once- Pre intervention week 1 - Post intervention in week 16

Child Behavior Checklist (CBCL by Achenbach)

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16

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

Timeframe: Once- Pre intervention week 1 - Post intervention in week 16