- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663916
Dog-Assisted Therapy in Adolescents Attending a Child and Adolescent Mental Health Day Hospital (DAT-MH-DH)
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.
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]
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Barcelona
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Barcelona, Barcelona, Spain, 08036
- Hospital Clinic de Barcelona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Estimated intelligence quotient (IQ) below 80
- Allergy to dogs
- Fear of dogs or animal phobia
- History of aggressive behavior towards animals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dog-Assisted Therapy + Treatment as Usual
Participants 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. |
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.
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.
|
|
Active Comparator: Treatment as Usual
Participants 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 |
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HONOSCA
Time Frame: Baseline and post-intervention at Week 8
|
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.
|
Baseline and post-intervention at Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in state anxiety (STAIC)
Time Frame: Baseline and post-intervention at Week 8
|
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.
|
Baseline and post-intervention at Week 8
|
|
Change in emotional regulation difficulties (DERS)
Time Frame: Baseline and post-intervention at Week 8
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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.
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Baseline and post-intervention at Week 8
|
|
Change in depressive symptoms (CDI)
Time Frame: Baseline and post-intervention at Week 8
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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.
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Baseline and post-intervention at Week 8
|
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Change in eating disorder symptomatology (EDI-2)
Time Frame: Baseline and post-intervention at Week 8
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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.
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Baseline and post-intervention at Week 8
|
|
Immediate change in emotional state (FIS)
Time Frame: Immediately before and after each session, throughout the 8-week intervention period]
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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.
|
Immediately before and after each session, throughout the 8-week intervention period]
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- Beatriz MN, Javier FS, Ana Myriam LP, Luis-Lucio LR, Manuel FG, Israel GG, Montserrat GB, Daniel CM. 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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