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

NCT06414850 | Completed

• 1 other identifier: Multicenter study
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

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.

Conditions

Mental Health Issue

Keywords

Animal-assisted therapy; Mental Health; Adolescent Psychiatry; Hospital; Nonpharmaceutical interventions

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Participant evaluation questionnaire for professionals.

  At the end of the intervention (week 2).

Other Outcomes (1)

• Participant satisfaction questionnaire at the end of the intervention.

  At the end of the intervention (week 2).

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

The experimental group carried out a total of two one-hour group sessions at the three hospitals' own facilities, on a weekly basis for two consecutive weeks. The groups were formed by 8-10 participants. Sessions included the participation of one certified therapy dog, one technician specialized in AAT, an occupational therapist and a psychologist. There was a referring psychiatrist for the project at each center. Participants received their usual pharmacological treatment. Intervention (with the additional assistance of the therapy dog): Session 1, self-efficacy (executive functions, cause-effect thinking). Session 2, emotional self-regulation and frustration tolerance.

Behavioral: Animal Assisted Therapy (AAT)

Control Group (CG)

ACTIVE COMPARATOR

The control group carried out a total of two one-hour group sessions at the hospital's own facility, on a weekly basis for two consecutive weeks. The groups were formed by 8-10 participants. Sessions included the participation of an occupational therapist and a psychologist. There was a referring psychiatrist for the project. Participants received their usual pharmacological treatment. Intervention (same sessions without the therapy dog): Session 1, self-efficacy (executive functions, cause-effect thinking). Session 2, emotional self-regulation and frustration tolerance.

Behavioral: Animal Assisted Therapy (AAT)

Interventions

Animal Assisted Therapy (AAT) BEHAVIORAL

A structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group.

Also known as: Dog assisted Therapy

Control Group (CG); Experimental Group (EG)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital Universitari Santa Maria

Lleida, 25198, Spain

Location

Hospital Universitario Infantil Niño Jesús

Madrid, 28009, Spain

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• M. Dolores Rodrigo Claverol, PhD

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, non-randomized, controlled, open-label, two-arm clinical trial

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: February 12, 2020
• Primary Completion: January 7, 2022
• Study Completion: January 7, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)