Clinical trial NCT06414850: Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units.
Official title: Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Keywords: Animal-assisted therapy
Mental Health
Adolescent Psychiatry
Hospital
Nonpharmaceutical interventions
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Santa Maria, Lleida
name: Hospital de Mataró
name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Universidad Rey Juan Carlos
First posted: 2024-05-16
Enrollment: 178
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multicenter, non-randomized, controlled, open-label, two-arm clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the present study was to evaluate the efficacy of AAT intervention in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit, regardless of diagnosis, in terms of improving self-efficacy and reducing anxiety symptoms. To assess professional opinions on the effects of intervention on participants, and to determine participant satisfaction. These objectives were accomplished through a multicenter, non-randomized, open-label, two-arm controlled study of AAT for adolescents with mental disorders.

Detailed description: The rationale of this study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in adolescents admitted to the Acute Child and Adolescent Psychiatry Unit and regardless of diagnosis. The investigators conducted a multicenter, non-randomized, controlled, open-label, two-arm clinical trial in three hospitals. A total of 178 adolescents admitted to the Acute Child and Adolescent Psychiatry Unit were included in the study. Participants from the three hospitals were assigned to Experimental Group (n=114) and participants from one hospital were assigned to Control Group (n=64). Both the experimental group and the control group carried out a total of two one-hour group sessions at the hospitals' own facilities, on a weekly basis for two consecutive weeks; with the additional assistance of the therapy dog in the Experimental group. The investigators evaluated changes on self-efficacy and anxiety symptoms at pre-treatment and post-treatment; and they assessed professional opinions on the effects of intervention on participants at post-treatment, and determined participant satisfaction at post-treatment.

Eligibility criteria: Inclusion Criteria:

* Be between 13 and 17 years of age.
* Willing to participate in the study on a voluntary basis.
* Delivery of the information sheet and signature of the informed consent (participant and legal guardian).
* Attendance at both group sessions from the intervention.

Exclusion Criteria:

* If in the initial interview they declared having allergy or fear of dogs.
* History of aggression towards animals.
* Re-admissions who had already participated in the study.
* If, when informed, the patient and/or his/her legal guardian did not wish to participate in the study.

Primary outcomes:
measure: Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.
timeFrame: This scale was administered at baseline and at week 2
measure: Change from baseline State-Trait Anxiety Inventory Questionnaire (STAI) at 2 weeks.
timeFrame: This questionnaire was administered at baseline and at week 2
Secondary outcomes:
measure: Participant evaluation questionnaire for professionals.
timeFrame: At the end of the intervention (week 2).
Other outcomes:
measure: Participant satisfaction questionnaire at the end of the intervention.
timeFrame: At the end of the intervention (week 2).
Locations:
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Lleida
country: Spain
facility: Hospital Universitari Santa Maria
city: Madrid
country: Spain
facility: Hospital Universitario Infantil Niño Jesús
Study officials:
affiliation: Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol)
name: M. Dolores Rodrigo Claverol, PhD
role: PRINCIPAL_INVESTIGATOR
References: