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Clinical Trials/NCT06496685
NCT06496685
Completed
N/A

Dog Assisted Therapy Program for Children With Attention Deficit Hyperactivity Disorder: a Randomized Clinical Trial

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina2 sites in 1 country36 target enrollmentDecember 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Disorder With Hyperactivity
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
36
Locations
2
Primary Endpoint
Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. These objectives were accomplished through a multicenter, randomized clinical trial, open-label, two-arm study of AAT for children with ADHD.

Detailed Description

The purpose of the present study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in in children with Attention Deficit Hyperactivity Disorder (ADHD). The investigators conducted a multicenter, randomized, controlled, open-label, two-arm clinical trial. Thirty-six children aged 7-12 diagnosed with ADHD were randomized in two groups. Experimental group: 14 animal assisted therapy (AAT) psychoeducational sessions (once-a-week, 60 minutes) + treatment as usual and control group: treatment as usual. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. The investigators evaluated changes on functionality, ADHD-associated symptoms, attention and working memory at pre-treatment and post-treatment. Assessment included intelligence test, ADHD symptoms referred by parents and teacher's (Conners Rating Scale), attention measures (Conners Continuous Performance Test (CPT-3) and children's functioning (Children's Global Assessment Scale (CGAS)).

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
April 27, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 7 and 12 years old (included).
  • Diagnosis of ADHD confirmed at the Child and Adolescent Mental Health Service.
  • Intelligence quotient of 80 or higher.
  • Delivery of the information sheet and signature of the informed consent.

Exclusion Criteria

  • If in the initial interview they declared having allergy or fear of dogs.
  • History of aggression towards animals.
  • Co-morbidity with other disorders (conduct disorders, autism spectrum disorders, anxiety disorder or depression).
  • If the treatment regimen was modified during the intervention period.

Outcomes

Primary Outcomes

Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.

Time Frame: This scale was administered at baseline and at week 14

It is a numerical scale to rate the overall functioning of young people under 18 years of age. Scores range from 1 to 100. A higher score indicates better functioning.

Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks

Time Frame: This scale was administered at baseline and at week 14

Is an instrument for measuring symptom severity of patients with mental disorders. Uses a single item on a Likert scale of seven values from 1= "Normal, not at all ill" to 7= "Among the most extremely ill patients".

Secondary Outcomes

  • Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.(This scale was administered at baseline and at week 14)
  • Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks(This test was administered at baseline and at week 14)

Study Sites (2)

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