Dog-Assisted Therapy for Children and Adolescents With FASD

NCT ID: NCT04038164

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-04-02

Brief Summary

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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

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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

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FASD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Rater-blinded

Study Groups

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Dog-Assisted Therapy (DAT) and pharmacological treatment

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.

Group Type EXPERIMENTAL

Dog-Assisted Therapy and pharmacological treatment

Intervention Type BEHAVIORAL

The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Treatment as usual (TAU, pharmacological treatment)

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.

Group Type ACTIVE_COMPARATOR

Dog-Assisted Therapy and pharmacological treatment

Intervention Type BEHAVIORAL

The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Interventions

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Dog-Assisted Therapy and pharmacological treatment

The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who were not behaviorally stable
* Patients that required hospitalization, day hospital or more intensive treatments.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raquel Vidal

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebron

Locations

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Vall d'Hebron Research Institute

Barcelona, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 37340213 (View on PubMed)

Vidal 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.

Reference Type DERIVED
PMID: 32528389 (View on PubMed)

Other Identifiers

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PR(AG)94/2018

Identifier Type: -

Identifier Source: org_study_id

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