Dog Assisted Therapy Program for Children With ADHD

NCT ID: NCT06496685

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2023-04-27

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)).

Conditions

Attention Deficit Disorder With Hyperactivity; Animal Assisted Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

psychoeducational

Intervention Type: OTHER

A structured AAT program and usual treatment in Experimental group.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

psychoeducational

A structured AAT program and usual treatment in Experimental group.

Intervention Type: OTHER

Other Intervention Names

Animal Assisted Therapy

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Dolores Rodrigo Claverol, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Locations

Centre Atenció Primària Bordeta-Magraners

Lleida, , Spain

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

Lleida, , Spain

Countries

Spain

Other Identifiers

P18/079

Identifier Type: -

Identifier Source: org_study_id