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Completed

NCT Number: NCT06414850

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

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Mataró, Mataró, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dog assisted Therapy

Primary outcomes

  1. 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.

  2. 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

  1. Participant evaluation questionnaire for professionals.

    Time frame: At the end of the intervention (week 2).

    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?

Other outcomes

  1. Participant satisfaction questionnaire at the end of the intervention.

    Time frame: At the end of the intervention (week 2).

    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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain
  • Hospital Universitari Santa Maria, Spain
  • Hospital de Mataró
  • Universidad Rey Juan Carlos

Registry information

Official study title

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

Acronym: MENTAL-DOG

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 16, 2024
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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