Dog-Assisted Therapy for Children and Adolescents With FASD

NCT04038164 | Completed DMC

• 1 other identifier: PR(AG)94/2018
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. This objective was accomplished through a randomized controlled pilot study of DAT for children and adolescents with FASD.

Conditions

FASD

Keywords

FASD; animal-assisted therapy; dog-assisted therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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 The CBCL is a 113 item scale (Likert scale: 0-2) which assesses withdrawn symptoms, somatic complains, anxiety/depressive symptoms, thought problems, ADHD features, oppositional behavior and behavioral problems.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.

  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) .

  Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)

Study Arms (2)

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.

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.

Behavioral: Dog-Assisted Therapy and pharmacological treatment

Interventions

Dog-Assisted Therapy and pharmacological treatment BEHAVIORAL

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

Dog-Assisted Therapy (DAT) and pharmacological treatment; Treatment as usual (TAU, pharmacological treatment)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients who were not behaviorally stable
• Patients that required hospitalization, day hospital or more intensive treatments.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location

Related Publications (2)

• 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.

  PMID: 37340213 DERIVED

• 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.

  PMID: 32528389 DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Raquel Vidal

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Rater-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 30, 2019
• Study Start: April 2, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: July 30, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)