Clinical trial NCT06496685: Dog Assisted Therapy Program for Children With ADHD
Official title: Dog Assisted Therapy Program for Children With Attention Deficit Hyperactivity Disorder: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. And randomized in two groups.
Primary purpose: TREATMENT

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)).

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.

Primary outcomes:
measure: Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
timeFrame: This scale was administered at baseline and at week 14
measure: Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks
timeFrame: This scale was administered at baseline and at week 14
Secondary outcomes:
measure: Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.
timeFrame: This scale was administered at baseline and at week 14
measure: Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks
timeFrame: This test was administered at baseline and at week 14
Other outcomes:
measure: Change from baseline Conners Rating Scales Revised at 14 weeks.
timeFrame: This scale was administered at baseline and at week 14
Locations:
city: Lleida
country: Spain
facility: Centre Atenció Primària Bordeta-Magraners
city: Lleida
country: Spain
facility: Salut Mental Infanto-Juvenil Sant Joan de Déu Terres de Lleida
Study officials:
affiliation: Institut Català de la Salut
name: M. Dolores Rodrigo Claverol, PhD
role: PRINCIPAL_INVESTIGATOR
References: