Fetal Alcohol Spectrum DisordersNCT06763614
Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder
A study testing Dog assisted therapy - animal interventions in people with Fetal Alcohol Spectrum Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Dog assisted therapy - animal interventions
- 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
- 20 Feb 2022to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
About this study
Official title: A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.
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.
Read the detailed description
FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.
Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.
- Conditions
- Fetal Alcohol Spectrum Disorders
- Being tested
- Dog assisted therapy - animal interventions
- 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 therapy - animal interventionsBehavioural
Animal Assisted Therapy is when animals are used in goal directed treatment sessions. These goals are working emotionalaspects pf childres and adolescents with SAF
| Study group | Role | What they receive |
|---|---|---|
| A Randomised Controlled Study Of Dog Assisted Therapy | Experimental | We tested 8 week dog assisted therapy for patients with FASD vs 16 week treatment for patients with FASD Receives: Behavioral: Dog assisted therapy - animal interventions |
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: Once- Pre intervention week 1 - Post intervention in week 16
Child Behavior Checklist (CBCL by Achenbach)
Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113
Measured: Once- Pre intervention week 1 - Post intervention in week 16
Social Skills Improvement System-Parent Form (SSIS-P)
Social skills assessment - 0 to 60 max scotring
Measured: Once- Pre intervention week 1 - Post intervention in week 16
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Quality of life assesment
Measured: Once- Pre intervention week 1 - Post intervention in week 16
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Severity of FASD symptoms
Measured: Once- Pre intervention week 1 - Post intervention in week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start20 Feb 2022
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal Alcohol Spectrum DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Probitas
- Responsible party
- Sponsor
- Investigators
- Josep Antoni Ramos Quirogfa, MD-PHD, Study director, Comitè Ètic d'Investigació Clínica HUVH Barcelona, Barcelona Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763614
- Sponsor's protocol ID
- DAT-VH-2023
- Status last verified
- Jul 2023
- First submitted
- 22 Jul 2024
- Last updated
- 8 Jan 2025
- 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.
Publications
Munoz-Caller S, Vidal R, Lugo J, Ristol F, Veiga A, Vico C, Ramos-Quiroga JA, Gomez-Barros N. A randomised controlled study of dog assisted therapy: comparing a short and a long version for patients with fetal alcohol spectrum disorder. Front Psychol. 2026 Apr 7;17:1720834. doi: 10.3389/fpsyg.2026.1720834. eCollection 2026.
PubMed 42022399
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT06763614
- Acronym / sponsor ID
- DAT-VH-2023
- Conditions
- Fetal Alcohol Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Fundacion Probitas
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 8 Jan 2025 (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.
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.
Detailed description
FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.
Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Randomised Controlled Study Of Dog Assisted Therapy | Experimental | Behavioral: Dog assisted therapy - animal interventionsWe tested 8 week dog assisted therapy for patients with FASD vs 16 week treatment for patients with FASD |
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 therapy - animal interventionsAnimal Assisted Therapy is when animals are used in goal directed treatment sessions. These goals are working emotionalaspects pf childres and adolescents with SAF | Behavioural | A Randomised Controlled Study Of Dog Assisted Therapy |
Primary outcome
Wechsler Intelligence Scale for Children
Time frame: Once- Pre intervention week 1 - Post intervention in week 16
Intellectual Quotient
Child Behavior Checklist (CBCL by Achenbach)
Time frame: Once- Pre intervention week 1 - Post intervention in week 16
Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113
Social Skills Improvement System-Parent Form (SSIS-P)
Time frame: Once- Pre intervention week 1 - Post intervention in week 16
Social skills assessment - 0 to 60 max scotring
KidScreen 27- 0 maximum 135 - highest severity symptoms at 135
Time frame: Once- Pre intervention week 1 - Post intervention in week 16
Quality of life assesment
Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).
Time frame: Once- Pre intervention week 1 - Post intervention in week 16
Severity of FASD symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 42022399Munoz-Caller S, Vidal R, Lugo J, Ristol F, Veiga A, Vico C, Ramos-Quiroga JA, Gomez-Barros N. A randomised controlled study of dog assisted therapy: comparing a short and a long version for patients with fetal alcohol spectrum disorder. Front Psychol. 2026 Apr 7;17:1720834. doi: 10.3389/fpsyg.2026.1720834. eCollection 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 Spectrum Disorders
RecruitingObservational study
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FASD Prevention R33
Alcohol and Tobacco/Cannabis Use
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Families Moving Forward (FMF) Connect Pro for Mental Health Providers
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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.
Josep Antoni Ramos Quirogfa, MD-PHD study director
Comitè Ètic d'Investigació Clínica HUVH Barcelona, Barcelona Spain
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 - animal interventions in people with Fetal Alcohol Spectrum Disorders, 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: finished, as of the sponsor's last update on 8 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Once- Pre intervention week 1 - Post intervention in week 16). 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?
On the ClinicalTrials.gov record for NCT06763614, which also lists 1 linked publication.
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 8 Jan 2025.