Dog Assisted Therapy Program for Children With ADHD (DOGAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity; Animal Assisted Therapy
• Intervention / Treatment: Other: psychoeducational

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)).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25001
    • Centre Atenció Primària Bordeta-Magraners
  • Lleida, Spain, 25001
    • Salut Mental Infanto-Juvenil Sant Joan de Déu Terres de Lleida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group carried out a total of 14 one-hour group sessions, on a weekly basis for 14 consecutive weeks. The groups were formed by 8 participants. Sessions included the participation of one certified therapy dog, one technician specialized in AAT and a psychologist. Participants received their usual treatment (pharmacological and/or individual and family cognitive-behavioral treatment). Intervention: All sessions: Establishment of structured routines and schedules to help the child organize and manage daily responsibilities. Positive reinforcement to reward and motivate desirable behaviors. Sessions 1-7: Impulsivity management techniques. Social skills training. Self-control techniques to identify and manage moments of impulsivity. Sessions 8-14: Reinforcement of attention and concentration through strategies such as dividing tasks into smaller, more manageable parts. Cognitive-behavioral therapy to work on self-esteem, self-control and problem solving.	Other: psychoeducational; A structured AAT program and usual treatment in Experimental group.; Other Names: Animal Assisted Therapy
No Intervention: Control Group; Treatment as usual (pharmacological and/or individual and family cognitive-behavioral treatment).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.	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.	This scale was administered at baseline and at week 14
Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks	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".	This scale was administered at baseline and at week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.	This instrument measures intellectual ability of children from 6 to 16 years. It was developed to provide an overall measure of general cognitive ability, and measures of intellectual functioning in Verbal Comprehension, Perceptual Reasoning, Working Memory and Processing Speed. The full version of the WISC-IV has 15 subtests, only ten are considered core, and used more often when testing intelligence.	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 is a task-oriented computerized assessment of attention-related problems in individuals aged 8 years and older. By indexing the respondent's performance in areas of inattentiveness, impulsivity, sustained attention and vigilance.	This test was administered at baseline and at week 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Conners Rating Scales Revised at 14 weeks.	In this study we used the short parents' version (27 items) and teachers' version (28 items). The scale is divided into 4 subscales: oppositional, inattention, hyperactivity -impulsivity and ADHD Index. Each item is scored from 0 to 3 (0= not true, 3= is always true). A typical score ≥70 indicates the presence of alterations in the subscale.	This scale was administered at baseline and at week 14

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: M. Dolores Rodrigo Claverol, PhD, Institut Català de la Salut

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Children; Psychiatry; Psychotherapy; Animal Assisted Therapy; Attention Deficit Disorder with Hyperactivity; Primary Health Care Center
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: P18/079

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No