Fetal Alcohol EffectNCT07717190
Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study
A study testing Dog assisted therapy in people with Fetal Alcohol Effect and Fetal Alcohol Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Fetal Alcohol Effect, Fetal Alcohol Syndrome, Fetal Alcohol Syndrome Disorders
- What is being tested?
- Dog assisted therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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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Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona 08035
Barcelona, Barcelona, 08035
About this 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.
Read the 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.
- Being tested
- Dog assisted therapy
- Keywords
- Dog-assisted therapy, Fetal alcohol spectrum disorder L, ongitudinal follow-up, Child and adolescent mental health, Caregivers' emotional well-being.
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dog assisted therapyBehavioural
Also called DAT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Dog assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Intelligence Scale for Children
Intellectual Quotient
Measured: Single administration baseline
Child Behavior Checklist (CBCL by Achenbach)
Internalizing/ Externalizing Symptoms maximum scores for symptom severity
Measured: 3, 6 and 12 months after baseline
Social Skills Improvement System-Parent Form (SSIS-P)
Social skills assessment - 0 to 60 max scotring
Measured: 3, 6 and 12 months after baseline
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Quality of life assesment
Measured: 3, 6 and 12 months after baseline
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Severity of FASD symptoms
Measured: 3,6 and 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol EffectStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717190
- Sponsor's protocol ID
- PR(AG)229-2026
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data collected from the patients evaluated in our hospital will be stored in the medical records of Vall d'Hebron University Hospital, as well as in a computerized database that allows for analysis. Rigorous confidentiality of the data will be maintained in accordance with current regulations in Spain (Ley Orgánica de Protección de Datos). To analyze the final data from the three hospitals, each patient will be coded (anonymous code) to facilitate data processing.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study
- ClinicalTrials.gov ID
- NCT07717190
- Acronym / sponsor ID
- PR(AG)229-2026
- Keywords
- Dog-assisted therapy, Fetal alcohol spectrum disorder L, ongitudinal follow-up, Child and adolescent mental health, Caregivers' emotional well-being.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Long-term Follow-up of Dog-Assisted Therapy. | Other | Behavioral: Dog assisted therapyThis 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dog assisted therapyAlso: DATThe 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. | Behavioural | Long-term Follow-up of Dog-Assisted Therapy. |
Primary outcome
Wechsler Intelligence Scale for Children
Time frame: Single administration baseline
Intellectual Quotient
Child Behavior Checklist (CBCL by Achenbach)
Time frame: 3, 6 and 12 months after baseline
Internalizing/ Externalizing Symptoms maximum scores for symptom severity
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
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Time frame: 3, 6 and 12 months after baseline
Quality of life assesment
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided. The data collected from the patients evaluated in our hospital will be stored in the medical records of Vall d'Hebron University Hospital, as well as in a computerized database that allows for analysis. Rigorous confidentiality of the data will be maintained in accordance with current regulations in Spain (Ley Orgánica de Protección de Datos). To analyze the final data from the three hospitals, each patient will be coded (anonymous code) to facilitate data processing.
Related trials for Fetal Alcohol Effect
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Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure
Fetal Alcohol Spectrum Disorders, Attention Deficit Hyperactivity Disorder
Not yet recruitingPhase 2
FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
Recruiting
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
Fetal Alcohol Spectrum Disorders
Recruiting
The Synchrony Study: Examining Music Training for Children With FASD
Fetal Alcohol Spectrum Disorders
RecruitingPhase 2
Pilot Study of Prenatal Choline Supplementation
Brain Development, Choline Nutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dog assisted therapy in people with Fetal Alcohol Effect and Fetal Alcohol Syndrome, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Intelligence Scale for Children (time frame: Single administration baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.