Dog Assisted Therapy Program for Children With ADHD

NCT06496685 | Completed DMC

• 1 other identifier: P18/079
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Disorder With Hyperactivity; Animal Assisted Therapy

Keywords

Animal Assisted Therapy; Attention Deficit Disorder with Hyperactivity; Children; Primary Health Care Center; Psychotherapy; Psychiatry

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Other Outcomes (1)

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

  This scale was administered at baseline and at week 14

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Treatment as usual (pharmacological and/or individual and family cognitive-behavioral treatment).

Interventions

psychoeducational OTHER

A structured AAT program and usual treatment in Experimental group.

Also known as: Animal Assisted Therapy

Experimental Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (2)

Centre Atenció Primària Bordeta-Magraners

Lleida, 25001, Spain

Location

Salut Mental Infanto-Juvenil Sant Joan de Déu Terres de Lleida

Lleida, 25001, Spain

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• M. Dolores Rodrigo Claverol, PhD

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. And randomized in two groups.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: December 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: April 27, 2023
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

ES (2)