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Mental Health Disorders in AdolescentsDAT-MH-DHNCT07663916

Dog-Assisted Therapy in Adolescents Attending a Child and Adolescent Mental Health Day Hospital

A study testing Experimental: Experimental: Dog-assisted therapy + Treatment as usual and Active Comparator: Treatment as usual in people with Mental Health Disorders in Adolescents and Emotional Dysregulation, run by Hospital Clinic of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to evaluate the feasibility and effectiveness of a dog-assisted therapy program integrated into a Child and Adolescent Mental Health Day Hospital, as well as to explore participants' subjective experiences. Read more about this study

Who is it for?
Ages 12 to 18 years
What is being tested?
Experimental: Experimental: Dog-assisted therapy + Treatment as usual and Active Comparator: Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
12 Jan 2024to 12 May 2026
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents aged between 12 and 18 years
  • Receiving treatment at a Child and Adolescent Mental Health Day Hospital
  • Willingness and motivation to participate in the intervention
  • Written informed consent provided by the participant and their legal guardians

Who cannot join

  • Estimated intelligence quotient (IQ) below 80
  • Allergy to dogs
  • Fear of dogs or animal phobia
  • History of aggressive behavior towards animals

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Clinic de Barcelona

    Barcelona, Barcelona, 08036

Other trials in Spain

About this study

Official title: Randomized Controlled Trial and Subjective Experience of Dog-Assisted Therapy in Adolescents Attending a Child and Adolescent Mental Health Day Hospital: A Mixed-Methods Study

This study aimed to evaluate the feasibility and effectiveness of a dog-assisted therapy program integrated into a Child and Adolescent Mental Health Day Hospital, as well as to explore participants' subjective experiences.

Mental health disorders in adolescence are common and often require intensive treatment approaches. Day hospitals provide structured care while allowing adolescents to remain in their family and social environments. Dog-assisted therapy has been proposed as a complementary intervention that may support emotional regulation, reduce distress, and enhance motivation and engagement in treatment.

Read more

A mixed-methods study was conducted, combining a randomized controlled trial with a qualitative phenomenological analysis. A total of 70 adolescents aged 12 to 18 years attending a mental health day hospital were included. Participants were randomly assigned to an experimental group, which received dog-assisted therapy in addition to treatment as usual, or to a control group that received treatment as usual only.

The intervention consisted of eight structured sessions of dog-assisted therapy, each lasting approximately 45 minutes. Clinical and emotional outcomes were assessed before and after the intervention using standardized instruments. In addition, immediate emotional changes were evaluated before and after each session. A qualitative component based on semi-structured interviews was conducted to better understand participants' experiences.

The study seeks to provide evidence on whether dog-assisted therapy can be a useful complementary intervention in adolescent mental health care, particularly in improving immediate emotional regulation, motivation, and therapeutic engagement.

This is an interventional trial registered retrospectively after study completion. Data were collected between [01/01/2024] and (31.12.2025]

Read the detailed description

Adolescence is a critical developmental period associated with increased vulnerability to mental health disorders, including affective, anxiety, behavioral, and eating disorders. These conditions often present with complex symptom profiles and significantly impact emotional regulation, interpersonal functioning, and engagement in treatment.

Child and Adolescent Mental Health Day Hospitals provide intensive, structured care while allowing adolescents to remain in their family and social environments. However, maintaining motivation and therapeutic engagement in this context can be challenging, highlighting the need for complementary interventions that facilitate emotional connection and participation.

Dog-Assisted Therapy (DAT) is a structured intervention involving interactions between patients and trained dogs under professional supervision, with predefined therapeutic goals. Previous research suggests that DAT may reduce stress and anxiety, enhance emotional regulation, and improve motivation and social interaction. Nevertheless, evidence from controlled studies in intensive treatment settings remains limited.

This study evaluates the effectiveness and feasibility of integrating DAT into routine care in a Child and Adolescent Mental Health Day Hospital. A mixed-methods design was used, combining a randomized controlled trial with a qualitative phenomenological approach.

Participants were randomly assigned to receive either DAT in addition to standard treatment or standard treatment alone. The intervention consisted of eight structured sessions delivered over approximately eight weeks within the Day Hospital program.

Quantitative analyses focused on changes in clinical and emotional outcomes between baseline and post-intervention, as well as between-group differences. In addition, immediate emotional responses associated with DAT sessions were explored. Qualitative data were collected through semi-structured interviews to examine participants' lived experiences and perceived impact of the intervention.

Data were analyzed using appropriate statistical methods for pre-post and between-group comparisons, alongside a phenomenological-hermeneutic analysis of qualitative data to identify emerging themes and capture subjective experience.

This study aims to contribute to the evidence base on complementary interventions in adolescent mental health care, particularly regarding the role of DAT in enhancing emotional regulation, motivation, and therapeutic engagement within intensive treatment settings.

Being tested
Experimental: Experimental: Dog-assisted therapy + Treatment as usual, Active Comparator: Treatment as usual
Keywords
Keywords: Dog-assisted therapy, Mental health day hospital, Mental health symptomatology
Medical subject headings
Anxiety Disorders, Depressive Disorder, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Experimental: Dog-assisted therapy + Treatment as usualBehavioural

    Participants received a structured dog-assisted therapy program integrated into routine care in a Child and Adolescent Mental Health Day Hospital. The intervention consisted of eight sessions, each lasting approximately 45 minutes.

    Each session followed a standardized structure including an initial phase of contact with the dog, a main phase involving structured therapeutic activities aimed at promoting emotional regulation, social interaction, and therapeutic engagement, and a closing phase for reflection.

    Sessions were delivered by mental health professionals with the support of a certified canine specialist.

  • Active Comparator: Treatment as usualOther

    Los participantes asignados al grupo de control recibieron el tratamiento habitual proporcionado en el Hospital de Día de Salud Mental Infantil y Adolescente, sin exposición a la terapia asistida con perros. La atención estándar incluyó un programa multidisciplinario compuesto por psicoterapia individual y grupal, psicoeducación, apoyo académico y actividades terapéuticas que se imparten de forma rutinaria en el entorno del hospital de día. Los participantes continuaron recibiendo esta atención estándar durante todo el período del estudio.

Study groups in NCT07663916
Study groupRoleWhat they receive
Dog-Assisted Therapy + Treatment as UsualExperimentalParticipants assigned to the experimental group received a structured dog-assisted therapy program in addition to treatment as usual provided in the Child and Adolescent Mental Health Day Hospital. The intervention consisted of eight sessions of dog-assisted therapy, each lasting approximately 45 minutes, integrated into routine clinical care. Each session followed a standardized structure including three phases: an initial contact phase with the dog to facilitate adaptation, a main phase involving structured therapeutic activities with the dog aimed at promoting emotional regulation, social interaction, and therapeutic engagement, and a closing phase focused on reflection and session completion. Sessions were conducted by mental health professionals with the support of a certified canine specialist. In addition to the intervention, participants continued receiving standard multidisciplinary care, including psychotherapy, psychoeducation, and educational support.
Receives: Behavioral: Experimental: Experimental: Dog-assisted therapy + Treatment as usual; Other: Active Comparator: Treatment as usual
Treatment as UsualActive comparatorParticipants assigned to the control group received treatment as usual provided in the Child and Adolescent Mental Health Day Hospital, without exposure to dog-assisted therapy. Standard care included a multidisciplinary program composed of individual and group psychotherapy, psychoeducation, academic support, and therapeutic activities routinely delivered within the day hospital setting. Participants continued receiving this standard care throughout the study period
Receives: Behavioral: Experimental: Experimental: Dog-assisted therapy + Treatment as usual; Other: Active Comparator: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HONOSCA

    Change in global clinical functioning assessed using the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA). This instrument evaluates behavioral, emotional, and psychosocial difficulties in adolescents attending mental health services. Higher scores indicate greater severity of problems. The outcome measures the difference between pre-intervention and post-intervention total scores.

    Measured: Baseline and post-intervention at Week 8

Secondary outcomes (5)
  1. Change in state anxiety (STAIC)

    Change in anxiety levels assessed using the State-Trait Anxiety Inventory for Children (state subscale). This instrument measures situational anxiety in children and adolescents, with higher scores indicating greater anxiety levels.

    Measured: Baseline and post-intervention at Week 8

  2. Change in emotional regulation difficulties (DERS)

    Change in emotional regulation difficulties measured using the Difficulties in Emotion Regulation Scale (DERS), a self-report instrument assessing multiple domains of emotional dysregulation. Higher scores indicate greater difficulties in emotional regulation.

    Measured: Baseline and post-intervention at Week 8

  3. Change in depressive symptoms (CDI)

    Change in depressive symptomatology assessed using the Children's Depression Inventory (CDI), a self-report measure widely used to evaluate depressive symptoms in children and adolescents. Higher scores indicate greater depressive symptoms.

    Measured: Baseline and post-intervention at Week 8

  4. Change in eating disorder symptomatology (EDI-2)

    Change in eating disorder-related symptoms assessed using the Eating Disorder Inventory-2 (EDI-2), administered only in participants diagnosed with eating disorders. Higher scores indicate greater symptom severity.

    Measured: Baseline and post-intervention at Week 8

  5. Immediate change in emotional state (FIS)

    Immediate change in self-reported emotional state assessed before and after each dog-assisted therapy session using the Facial Image Scale (FIS). This scale consists of five facial expressions ranging from very unhappy to very happy, providing a rapid measure of emotional response to the intervention.

    Measured: Immediately before and after each session, throughout the 8-week intervention period]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start12 Jan 2024
  3. Primary completion14 Dec 2025
  4. Study completion12 May 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Retrospectively Registered Interventional Trial
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07663916
Sponsor's protocol ID
2023-0075
Acronym
DAT-MH-DH
Status last verified
May 2026
First submitted
28 May 2026
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared due to the sensitive nature of the data, which involves minors receiving mental health care. Data protection regulations and ethical considerations limit the possibility of sharing identifiable or detailed individual-level data. Aggregated results will be reported in scientific publications.

Publications

  • Hinic K, Kowalski MO, Holtzman K, Mobus K. The Effect of a Pet Therapy and Comparison Intervention on Anxiety in Hospitalized Children. J Pediatr Nurs. 2019 May-Jun;46:55-61. doi: 10.1016/j.pedn.2019.03.003. Epub 2019 Mar 7.

    PubMed 30852256
  • Martinez Nunez B, Fernandez Sanchez J, Lavin Perez AM, Lobato Rincon LL, Fonseca Garcia M, Gonzalez Garcia I, Graell Berna M, Collado Mateo D. Effects of Dog-assisted Therapy in Anxiety Symptoms of Female Adolescents With Eating Disorders: A Controlled Trial. Actas Esp Psiquiatr. 2025 Dec;53(6):1265-1273. doi: 10.62641/aep.v53i6.1919.

    PubMed 41437761
  • Vidal R, Vidal L, Lugo J, Ristol F, Domenec E, Casas T, Veiga A, Vico C, Ramos-Quiroga JA, Gomez-Barros N. Dog-Assisted Therapy vs Relaxation for Children and Adolescents with Fetal Alcohol Spectrum Disorder: A Randomized Controlled Study. J Autism Dev Disord. 2024 Aug;54(8):3133-3141. doi: 10.1007/s10803-023-06023-5. Epub 2023 Jun 20.

    PubMed 37340213
  • London MD, Mackenzie L, Lovarini M, Dickson C, Alvarez-Campos A. Animal Assisted Therapy for Children and Adolescents with Autism Spectrum Disorder: Parent perspectives. J Autism Dev Disord. 2020 Dec;50(12):4492-4503. doi: 10.1007/s10803-020-04512-5.

    PubMed 32333302
  • Garrocho-Rangel A, Rosales-Berber M, Rios-Mendez D, Flores-Velazquez J, Trejo-Herbert D, Pozos-Guillen F, Pozos-Guillen A. Dog-Assisted Therapy (DAT) for the management of anxiety during paediatric dental care. A scoping review. Eur J Paediatr Dent. 2024 Jun 3;25(2):120-125. doi: 10.23804/ejpd.2024.2001. Epub 2024 Mar 1.

    PubMed 38501910
  • Guillen Guzman E, Sastre Rodriguez L, Santamarina-Perez P, Hermida Barros L, Garcia Giralt M, Domenec Elizalde E, Ristol Ubach F, Romero Gonzalez M, Pastor Yuste Y, Diaz Tellez C, Romero Cela S, Real Gisbert L, Salmeron Medina M, Ballesteros-Urpi A, Morer Linan A. The Benefits of Dog-Assisted Therapy as Complementary Treatment in a Children's Mental Health Day Hospital. Animals (Basel). 2022 Oct 19;12(20):2841. doi: 10.3390/ani12202841.

    PubMed 36290226
  • Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.

    PubMed 24731910

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: Experimental: Dog-assisted therapy + Treatment as usual and Active Comparator: Treatment as usual in people with Mental Health Disorders in Adolescents and Emotional Dysregulation, run by Hospital Clinic of Barcelona at 1 site 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

HONOSCA (time frame: Baseline and post-intervention at Week 8). 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 NCT07663916, which also lists 7 linked publications.

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 23 Jun 2026.

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