Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units.

Mental Health Issue Clinical Trial

— MENTAL-DOG  

Official title:

Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06414850
• Other study ID #: Multicenter study
• Status: Completed
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: January 7, 2022

Study information

• Verified date: April 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: January 7, 2022
• Est. primary completion date: January 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• Animal Assisted Therapy (AAT)
A structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group.

Locations

Country	Name	City	State
Spain	Hospital Universitari Santa Maria	Lleida
Spain	Hospital Universitario Infantil Niño Jesús	Madrid
Spain	Hospital de Mataró	Mataró	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Hospital de Mataró, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitari Santa Maria, Lleida, Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant satisfaction questionnaire at the end of the intervention.	The following question was asked in writing and answered by all participants (CG + EG): Did you enjoy the activity that was carried out? It consists of a Likert scale of 1= Not at all, 2= Somewhat, 3= Quite and 4= A lot.	At the end of the intervention (week 2).
Primary	Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.	Is a generic self-administered instrument for measuring self-efficacy beliefs in certain life situations. The total scale score ranges from 10 to 40 points.	This scale was administered at baseline and at week 2
Primary	Change from baseline State-Trait Anxiety Inventory Questionnaire (STAI) at 2 weeks.	Is a self-administered questionnaire that assesses the levels of clinical anxiety (both trait anxiety ("most of the time") and state anxiety ("at the present moment")). The total score on each of the subscales ranges from 0 to 60 points.	This questionnaire was administered at baseline and at week 2
Secondary	Participant evaluation questionnaire for professionals.	This is a questionnaire that was completed by the professionals in the three hospitals at the end of the intervention with the EG, using a Likert scale from 1 to 4 (1= Not at all, 2= Somewhat, 3= Quite, and 4= A lot). It contains the following questions: Have you observed any positive changes in the patient's attitude since the AAT session?; Has the dog generated motivation?; Do you consider AAT useful for this patient?	At the end of the intervention (week 2).