NCT07663916

Brief 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. 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\]

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 28, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Keywords: Dog-assisted therapyMental health day hospitalMental health symptomatology

Outcome Measures

Primary Outcomes (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.

    Baseline and post-intervention at Week 8

Secondary Outcomes (5)

  • Change in state anxiety (STAIC)

    Baseline and post-intervention at Week 8

  • Change in emotional regulation difficulties (DERS)

    Baseline and post-intervention at Week 8

  • Change in depressive symptoms (CDI)

    Baseline and post-intervention at Week 8

  • Change in eating disorder symptomatology (EDI-2)

    Baseline and post-intervention at Week 8

  • Immediate change in emotional state (FIS)

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

Study Arms (2)

Dog-Assisted Therapy + Treatment as Usual

EXPERIMENTAL

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.

Behavioral: Experimental: Experimental: Dog-assisted therapy + Treatment as usualOther: Active Comparator: Treatment as usual

Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Experimental: Experimental: Dog-assisted therapy + Treatment as usualOther: Active Comparator: Treatment as usual

Interventions

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.

Dog-Assisted Therapy + Treatment as UsualTreatment as Usual

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.

Dog-Assisted Therapy + Treatment as UsualTreatment as Usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (7)

  • 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.

    PMID: 30852256BACKGROUND
  • 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.

    PMID: 41437761BACKGROUND
  • 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.

    PMID: 37340213BACKGROUND
  • 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.

    PMID: 32333302BACKGROUND
  • 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.

    PMID: 38501910BACKGROUND
  • 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.

    PMID: 36290226BACKGROUND
  • 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.

    PMID: 24731910BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressive DisorderFeeding and Eating Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersMood DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Retrospectively Registered Interventional Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 23, 2026

Study Start

January 12, 2024

Primary Completion

December 14, 2025

Study Completion

May 12, 2026

Last Updated

June 23, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations