FASDNCT04038164
Dog-Assisted Therapy for Children and Adolescents With FASD
A study testing Dog-Assisted Therapy and pharmacological treatment in people with FASD, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- FASD
- What is being tested?
- Dog-Assisted Therapy and pharmacological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2018to 2 Apr 2019
- 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
Who may be able to join
- Patients diagnosed with FASD between 6 and 18 years (FAS, pFAS or ARND)
- With or without comorbidities
- Stabilized doses of medication for at least 2 months before the study
- Patients with borderline IQ or mental retardation.
Who cannot join
- Patients who were not behaviorally stable
- Patients that required hospitalization, day hospital or more intensive treatments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study
The rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD.
Read the detailed description
The rationale of this study was to evaluate the efficacy of Dog Assisted Therapy in children and adolescents with FASD. The investigators conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16). The investigators evaluated changes on social skills, internalized and externalized symptomatology and on severity of FASD symptoms at pre-treatment and post-treatment.
- Conditions
- FASD
- Being tested
- Dog-Assisted Therapy and pharmacological treatment
- Keywords
- FASD, animal-assisted therapy, dog-assisted therapy
- 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 and pharmacological treatmentBehavioural
The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).
| Study group | Role | What they receive |
|---|---|---|
| Dog-Assisted Therapy (DAT) and pharmacological treatment | Experimental | The DAT program comprised 12 manualized sessions and included two phases: 1) individual intervention (6 sessions) and 2) group activity (6 sessions). Patients participated in weekly sessions for about 3 months. Each session lasted 45 minutes. The groups were formed by 3-4 patients. Sessions included the participation of two certified therapy dogs, two technicians specialized in DAT and a psychologist. Participants in this group were visited by their psychiatrist in order to monitor their adherence to medications. Receives: Behavioral: Dog-Assisted Therapy and pharmacological treatment |
| Treatment as usual (TAU, pharmacological treatment) | Active comparator | Participants received their usual treatment. They were visited by their psychiatrist in order to monitor their adherence and continuation on medications as prescribed. Inclusion and exclusion criteria were the same as for the experimental group. Participants in the TAU group did not receive DAT sessions. Receives: Behavioral: Dog-Assisted Therapy and pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on Social skills at 3 months
Social Skills Improvement System-Parent Form (SSIS-P). is a 79 items scale (Likert scale 0 to 4) measuring social skills and problem behaviors in children and adolescents as reported by their parents. In the Social Skills domain, the subscales are communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. The Problem Behaviors domain includes internalizing and externalizing problems, bullying, hyperactivity/inattention and autism spectrum.
Measured: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Change from baseline on Externalizing symptoms at 3 months
Child Behavior Checklist (CBCL of Achenbach) parent version. to assess Internalizing and Externalizing Symptoms in patients between 4 and 18 years. The CBCL is a 113 item scale (Likert scale: 0-2) which assesses withdrawn symptoms, somatic complains, anxiety/depressive symptoms, thought problems, ADHD features, oppositional behavior and behavioral problems. Higher scores indicate more conduct problems.
Measured: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Change from baseline FASD severity at 3 months
Clinical Global Impression Scale for Severity(CGI-S Clinician). The Clinical Global Impression Scale for Severity (CGI-S): is a 7-point scale (1 = normal or not ill, and 7 = extremely ill) .
Measured: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start2 Apr 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FASDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design was a randomized, rater-blinded, controlled pilot trial. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raquel Vidal, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038164
- Sponsor's protocol ID
- PR(AG)94/2018
- Status last verified
- Jul 2019
- First submitted
- 28 Jun 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vidal R, Vidal L, Lugo J, Ristol F, Domenec E, Casas T, Veiga A, Vico C, Ramos-Quiroga JA, Gomez-Barros N. Dog-Assisted Therapy vs Relaxation for Children and Adolescents with Fetal Alcohol Spectrum Disorder: A Randomized Controlled Study. J Autism Dev Disord. 2024 Aug;54(8):3133-3141. doi: 10.1007/s10803-023-06023-5. Epub 2023 Jun 20.
PubMed 37340213Vidal R, Vidal L, Ristol F, Domenec E, Segu M, Vico C, Gomez-Barros N, Ramos-Quiroga JA. Dog-Assisted Therapy for Children and Adolescents With Fetal Alcohol Spectrum Disorders a Randomized Controlled Pilot Study. Front Psychol. 2020 May 26;11:1080. doi: 10.3389/fpsyg.2020.01080. eCollection 2020.
PubMed 32528389
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04038164
- Acronym / sponsor ID
- PR(AG)94/2018
- Conditions
- FASD
- Keywords
- FASD, animal-assisted therapy, dog-assisted therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 30 Jul 2019 (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 rationale of the present study was to evaluate the efficacy of DAT in children and adolescents with FASD in relation to its effects on social skills, internalized and externalized symptomatology and on severity of FASD symptoms. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD.
Detailed description
The rationale of this study was to evaluate the efficacy of Dog Assisted Therapy in children and adolescents with FASD. The investigators conducted a randomized, rater-blinded, controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16). The investigators evaluated changes on social skills, internalized and externalized symptomatology and on severity of FASD symptoms at pre-treatment and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design was a randomized, rater-blinded, controlled pilot trial. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16).
| Arm | Type | Receives |
|---|---|---|
| Dog-Assisted Therapy (DAT) and pharmacological treatment | Experimental | Behavioral: Dog-Assisted Therapy and pharmacological treatmentThe DAT program comprised 12 manualized sessions and included two phases: 1) individual intervention (6 sessions) and 2) group activity (6 sessions). Patients participated in weekly sessions for about 3 months. Each session lasted 45 minutes. The groups were formed by 3-4 patients. Sessions included the participation of two certified therapy dogs, two technicians specialized in DAT and a psychologist. Participants in this group were visited by their psychiatrist in order to monitor their adherence to medications. |
| Treatment as usual (TAU, pharmacological treatment) | Active comparator | Behavioral: Dog-Assisted Therapy and pharmacological treatmentParticipants received their usual treatment. They were visited by their psychiatrist in order to monitor their adherence and continuation on medications as prescribed. Inclusion and exclusion criteria were the same as for the experimental group. Participants in the TAU group did not receive DAT sessions. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with FASD between 6 and 18 years (FAS, pFAS or ARND)
- With or without comorbidities
- Stabilized doses of medication for at least 2 months before the study
- Patients with borderline IQ or mental retardation.
Key exclusion criteria (2 listed)
- Patients who were not behaviorally stable
- Patients that required hospitalization, day hospital or more intensive treatments.
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 and pharmacological treatmentThe investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012). | Behavioural | Dog-Assisted Therapy (DAT) and pharmacological treatment, Treatment as usual (TAU, pharmacological treatment) |
Primary outcome
Change from baseline on Social skills at 3 months
Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Social Skills Improvement System-Parent Form (SSIS-P). is a 79 items scale (Likert scale 0 to 4) measuring social skills and problem behaviors in children and adolescents as reported by their parents. In the Social Skills domain, the subscales are communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. The Problem Behaviors domain includes internalizing and externalizing problems, bullying, hyperactivity/inattention and autism spectrum.
Change from baseline on Externalizing symptoms at 3 months
Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Child Behavior Checklist (CBCL of Achenbach) parent version. to assess Internalizing and Externalizing Symptoms in patients between 4 and 18 years. The CBCL is a 113 item scale (Likert scale: 0-2) which assesses withdrawn symptoms, somatic complains, anxiety/depressive symptoms, thought problems, ADHD features, oppositional behavior and behavioral problems. Higher scores indicate more conduct problems.
Change from baseline FASD severity at 3 months
Time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Clinical Global Impression Scale for Severity(CGI-S Clinician). The Clinical Global Impression Scale for Severity (CGI-S): is a 7-point scale (1 = normal or not ill, and 7 = extremely ill) .
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 30 Jul 2019.
- Derived from this study: PubMed 37340213Vidal R, Vidal L, Lugo J, Ristol F, Domenec E, Casas T, Veiga A, Vico C, Ramos-Quiroga JA, Gomez-Barros N. Dog-Assisted Therapy vs Relaxation for Children and Adolescents with Fetal Alcohol Spectrum Disorder: A Randomized Controlled Study. J Autism Dev Disord. 2024 Aug;54(8):3133-3141. doi: 10.1007/s10803-023-06023-5. Epub 2023 Jun 20.
- Derived from this study: PubMed 32528389Vidal R, Vidal L, Ristol F, Domenec E, Segu M, Vico C, Gomez-Barros N, Ramos-Quiroga JA. Dog-Assisted Therapy for Children and Adolescents With Fetal Alcohol Spectrum Disorders a Randomized Controlled Pilot Study. Front Psychol. 2020 May 26;11:1080. doi: 10.3389/fpsyg.2020.01080. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for FASD
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The Synchrony Study: Examining Music Training for Children With FASD
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Long-term Sustainability of the Effects of Dog-Assisted Therapy in Children and Adolescents With Fetal Alcohol Spectrum Disorder: a 12-month Longitudinal Study
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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.
Raquel Vidal principal investigator
Hospital Vall d'Hebron
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 and pharmacological treatment in people with FASD, 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 30 Jul 2019. 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?
Change from baseline on Social skills at 3 months (time frame: Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)). The study lists 3 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 NCT04038164, which also lists 2 linked publications.
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 30 Jul 2019.