Mental Health IssueMENTAL-DOGNCT06414850
Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units.
A study testing Animal Assisted Therapy (AAT) in people with Mental Health Issue, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Animal Assisted Therapy (AAT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesSpain
- Study dates
- 12 Feb 2020to 7 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Santa Maria
Lleida, 25198
Hospital Universitario Infantil Niño Jesús
Madrid, 28009
Hospital de Mataró
Mataró, Barcelona, 08304
About this study
Official title: Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.
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.
Read the 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
- Mental Health Issue
- Being tested
- Animal Assisted Therapy (AAT)
- Keywords
- Animal-assisted therapy, Mental Health, Adolescent Psychiatry, Hospital, Nonpharmaceutical interventions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted Therapy (AAT)Behavioural
Also called Dog assisted Therapy
A structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Animal Assisted Therapy (AAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: This questionnaire was administered at baseline and at week 2
Secondary outcomes (1)
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?
Measured: At the end of the intervention (week 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start12 Feb 2020
- Primary completion7 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Multicenter, non-randomized, controlled, open-label, two-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Santa Maria, Spain, Hospital de Mataró, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Universidad Rey Juan Carlos
- Responsible party
- Sponsor
- Investigators
- M. Dolores Rodrigo Claverol, PhD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414850
- Sponsor's protocol ID
- Multicenter study
- Acronym
- MENTAL-DOG
- Status last verified
- Apr 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodrigo-Claverol M, Manuel-Canals M, Lobato-Rincon LL, Roman-Casenave M, Rodriguez-Criado N, Rodrigo-Claverol E, Miro-Bernaus Y, Musull-Dulcet E, Gozalez-Garcia I, Pifarre J. Effectiveness of animal-assisted therapy in adolescent psychiatric inpatients: a multicenter clinical trial. BMC Complement Med Ther. 2026 Apr 17;26(1):199. doi: 10.1186/s12906-026-05385-4.
PubMed 41998672
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of an Animal-assisted Intervention in Adolescents Admitted to Acute Psychiatric Units: Mentaldog Multicenter Study.
- ClinicalTrials.gov ID
- NCT06414850
- Acronym / sponsor ID
- MENTAL-DOG / Multicenter study
- Conditions
- Mental Health Issue
- Keywords
- Animal-assisted therapy, Mental Health, Adolescent Psychiatry, Hospital, Nonpharmaceutical interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Hospital Universitari Santa Maria, Spain, Hospital de Mataró, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Universidad Rey Juan Carlos
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, non-randomized, controlled, open-label, two-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: Animal Assisted Therapy (AAT)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. |
| Control Group (CG) | Active comparator | Behavioral: Animal Assisted Therapy (AAT)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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted Therapy (AAT)Also: Dog assisted TherapyA structured AAT program and pharmacological treatment in Experimental group. The same structured program without therapy dog and pharmacological treatment in Control group. | Behavioural | Control Group (CG), Experimental Group (EG) |
Primary outcome
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.
1 secondary outcome
Participant evaluation questionnaire for professionals.
Time frame: At the end of the intervention (week 2).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 41998672Rodrigo-Claverol M, Manuel-Canals M, Lobato-Rincon LL, Roman-Casenave M, Rodriguez-Criado N, Rodrigo-Claverol E, Miro-Bernaus Y, Musull-Dulcet E, Gozalez-Garcia I, Pifarre J. Effectiveness of animal-assisted therapy in adolescent psychiatric inpatients: a multicenter clinical trial. BMC Complement Med Ther. 2026 Apr 17;26(1):199. doi: 10.1186/s12906-026-05385-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Dolores Rodrigo Claverol, PhD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Therapy (AAT) in people with Mental Health Issue, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline General Self-Efficacy Scale (GSE) at 2 weeks. (time frame: This scale was administered at baseline and at week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414850, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.