## Protocol Section
### Identification Module
**NCT ID:** NCT06414850

**Acronym:** MENTAL-DOG

**Brief Title:** 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.

#### Organization Study ID Info
**ID:** Multicenter study
#### Organization
**Class:** OTHER
**Full Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
### Status Module
#### Completion Date
**Date:** 2022-01-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-01-07

**Type:** ACTUAL

#### Start Date
**Date:** 2020-02-12

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Hospital Universitari Santa Maria, Lleida

**Class:** OTHER

**Name:** Hospital de Mataró

**Class:** OTHER

**Name:** Hospital Infantil Universitario Niño Jesús, Madrid, Spain

**Class:** OTHER

**Name:** Universidad Rey Juan Carlos

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Mental Health Issue

**Keywords:**

- Animal-assisted therapy

- Mental Health

- Adolescent Psychiatry

- Hospital

- Nonpharmaceutical interventions

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** Multicenter, non-randomized, controlled, open-label, two-arm clinical trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 178

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Animal Assisted Therapy (AAT)

**Label:** Experimental Group (EG)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: Animal Assisted Therapy (AAT)

**Label:** Control Group (CG)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group (CG)

- Experimental Group (EG)

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

**Name:** Animal Assisted Therapy (AAT)

**Other Names:**

- Dog assisted Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Participant satisfaction questionnaire at the end of the intervention.

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

#### Primary Outcomes

**Description:** 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.

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

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

**Description:** 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.

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

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

#### Secondary Outcomes

**Description:** 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?

**Measure:** Participant evaluation questionnaire for professionals.

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

### Eligibility Module

**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.

**Maximum Age:** 17 Years

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mataró

**Country:** Spain

**Facility:** Hospital de Mataró

**State:** Barcelona

**Zip:** 08304

**Location 2:**

**City:** Lleida

**Country:** Spain

**Facility:** Hospital Universitari Santa Maria

**Zip:** 25198

**Location 3:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario Infantil Niño Jesús

**Zip:** 28009

#### Overall Officials

**Official 1:**

**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

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
