Back to resultsDog-Assisted Therapy for Children and Adolescents With FASD
Primary Purpose
FASD
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dog-Assisted Therapy and pharmacological treatment
Sponsored by
About this trial
This is an interventional treatment trial for FASD focused on measuring FASD, animal-assisted therapy, dog-assisted therapy
Eligibility Criteria
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.
Sites / Locations
- Vall d'Hebron Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dog-Assisted Therapy (DAT) and pharmacological treatment
Treatment as usual (TAU, pharmacological treatment)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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) .
Secondary Outcome Measures
Full Information
NCT ID
NCT04038164
First Posted
June 28, 2019
Last Updated
July 29, 2019
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04038164
Brief Title
Dog-Assisted Therapy for Children and Adolescents With FASD
Official Title
Dog-Assisted Therapy for Children and Adolescents With FASD: a Randomized Controlled Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2, 2018 (Actual)
Primary Completion Date
April 2, 2019 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FASD
Keywords
FASD, animal-assisted therapy, dog-assisted therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Rater-blinded
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dog-Assisted Therapy (DAT) and pharmacological treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual (TAU, pharmacological treatment)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dog-Assisted Therapy and pharmacological treatment
Intervention Description
The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).
Primary Outcome Measure Information:
Title
Change from baseline on Social skills at 3 months
Description
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.
Time Frame
Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Title
Change from baseline on Externalizing symptoms at 3 months
Description
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.
Time Frame
Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
Title
Change from baseline FASD severity at 3 months
Description
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) .
Time Frame
Pre-treatment (baseline) and post-treatment assessment (through study completion, at 3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Vidal
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vall d'Hebron Research Institute
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32528389
Citation
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.
Results Reference
derived
Learn more about this trial
Dog-Assisted Therapy for Children and Adolescents With FASD
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