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Completed

NCT Number: NCT06496685

Dog Assisted Therapy Program for Children With ADHD

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Animal Assisted Therapy Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Atenció Primària Bordeta-Magraners, Lleida, Spain

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About this study

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)).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychoeducational

Other

A structured AAT program and usual treatment in Experimental group.

Other names: Animal Assisted Therapy

Primary outcomes

  1. 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.

  2. 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

  1. Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.

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

    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.

  2. Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks

    Time frame: This test was administered at baseline and at week 14

    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.

Other outcomes

  1. Change from baseline Conners Rating Scales Revised at 14 weeks.

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

    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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

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

Acronym: DOGAD

Important dates

Study start
2018
Primary completion
2019
Study completion
2023
First posted
Jul 11, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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