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Clinical Trials/NCT06414850
NCT06414850
Completed
N/A

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina3 sites in 1 country178 target enrollmentFebruary 12, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
178
Locations
3
Primary Endpoint
Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 12, 2020
End Date
January 7, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks.

Time Frame: This scale was administered at baseline and at week 2

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.

Change from baseline State-Trait Anxiety Inventory Questionnaire (STAI) at 2 weeks.

Time Frame: This questionnaire was administered at baseline and at week 2

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.

Secondary Outcomes

  • Participant evaluation questionnaire for professionals.(At the end of the intervention (week 2).)

Study Sites (3)

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