Attention Deficit Disorder With HyperactivityDOGADNCT06496685
Dog Assisted Therapy Program for Children With ADHD
A study testing psychoeducational in people with Attention Deficit Disorder With Hyperactivity and Animal Assisted Therapy, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
Trial summary
The purpose of this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Animal Assisted Therapy
- What is being tested?
- psychoeducational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2018to 27 Apr 2023
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 7 and 12 years old (included).
- Diagnosis of ADHD confirmed at the Child and Adolescent Mental Health Service.
- Intelligence quotient of 80 or higher.
- Delivery of the information sheet and signature of the informed consent.
Who cannot join
- If in the initial interview they declared having allergy or fear of dogs.
- History of aggression towards animals.
- Co-morbidity with other disorders (conduct disorders, autism spectrum disorders, anxiety disorder or depression).
- If the treatment regimen was modified during the intervention period.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centre Atenció Primària Bordeta-Magraners
Lleida, 25001
Salut Mental Infanto-Juvenil Sant Joan de Déu Terres de Lleida
Lleida, 25001
About this study
Official title: Dog Assisted Therapy Program for Children With Attention Deficit Hyperactivity Disorder: a Randomized Clinical Trial
The purpose of this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. These objectives were accomplished through a multicenter, randomized clinical trial, open-label, two-arm study of AAT for children with ADHD.
Read the detailed description
The purpose of the present study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in in children with Attention Deficit Hyperactivity Disorder (ADHD). The investigators conducted a multicenter, randomized, controlled, open-label, two-arm clinical trial. Thirty-six children aged 7-12 diagnosed with ADHD were randomized in two groups. Experimental group: 14 animal assisted therapy (AAT) psychoeducational sessions (once-a-week, 60 minutes) + treatment as usual and control group: treatment as usual. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. The investigators evaluated changes on functionality, ADHD-associated symptoms, attention and working memory at pre-treatment and post-treatment. Assessment included intelligence test, ADHD symptoms referred by parents and teacher's (Conners Rating Scale), attention measures (Conners Continuous Performance Test (CPT-3) and children's functioning (Children's Global Assessment Scale (CGAS)).
- Being tested
- psychoeducational
- Keywords
- Animal Assisted Therapy, Attention Deficit Disorder with Hyperactivity, Children, Primary Health Care Center, Psychotherapy, Psychiatry
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducationalOther
Also called Animal Assisted Therapy
A structured AAT program and usual treatment in Experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group carried out a total of 14 one-hour group sessions, on a weekly basis for 14 consecutive weeks. The groups were formed by 8 participants. Sessions included the participation of one certified therapy dog, one technician specialized in AAT and a psychologist. Participants received their usual treatment (pharmacological and/or individual and family cognitive-behavioral treatment).
Intervention:
All sessions: Establishment of structured routines and schedules to help the child organize and manage daily responsibilities. Positive reinforcement to reward and motivate desirable behaviors.
Sessions 1-7: Impulsivity management techniques. Social skills training. Self-control techniques to identify and manage moments of impulsivity.
Sessions 8-14: Reinforcement of attention and concentration through strategies such as dividing tasks into smaller, more manageable parts. Cognitive-behavioral therapy to work on self-esteem, self-control and problem solving. Receives: Other: psychoeducational |
| Control Group | No intervention | Treatment as usual (pharmacological and/or individual and family cognitive-behavioral treatment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
It is a numerical scale to rate the overall functioning of young people under 18 years of age. Scores range from 1 to 100. A higher score indicates better functioning.
Measured: This scale was administered at baseline and at week 14
Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks
Is an instrument for measuring symptom severity of patients with mental disorders. Uses a single item on a Likert scale of seven values from 1= "Normal, not at all ill" to 7= "Among the most extremely ill patients".
Measured: This scale was administered at baseline and at week 14
Secondary outcomes (2)
Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.
This instrument measures intellectual ability of children from 6 to 16 years. It was developed to provide an overall measure of general cognitive ability, and measures of intellectual functioning in Verbal Comprehension, Perceptual Reasoning, Working Memory and Processing Speed. The full version of the WISC-IV has 15 subtests, only ten are considered core, and used more often when testing intelligence.
Measured: This scale was administered at baseline and at week 14
Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks
This test is a task-oriented computerized assessment of attention-related problems in individuals aged 8 years and older. By indexing the respondent's performance in areas of inattentiveness, impulsivity, sustained attention and vigilance.
Measured: This test was administered at baseline and at week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Dec 2018
- Primary completion1 Feb 2019
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. And randomized in two groups.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M. Dolores Rodrigo Claverol, PhD, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496685
- Sponsor's protocol ID
- P18/079
- Acronym
- DOGAD
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dog Assisted Therapy Program for Children With Attention Deficit Hyperactivity Disorder: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06496685
- Acronym / sponsor ID
- DOGAD / P18/079
- Keywords
- Animal Assisted Therapy, Attention Deficit Disorder with Hyperactivity, Children, Primary Health Care Center, Psychotherapy, Psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 11 Jul 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 this study was to evaluate the efficacy of AAT intervention in children with Attention Deficit Hyperactivity Disorder (ADHD), in terms of improving functionality, ADHD-associated symptoms, attention and working memory. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. These objectives were accomplished through a multicenter, randomized clinical trial, open-label, two-arm study of AAT for children with ADHD.
Detailed description
The purpose of the present study was to evaluate the efficacy of Animal Assisted Therapy (with therapy dogs) in in children with Attention Deficit Hyperactivity Disorder (ADHD). The investigators conducted a multicenter, randomized, controlled, open-label, two-arm clinical trial. Thirty-six children aged 7-12 diagnosed with ADHD were randomized in two groups. Experimental group: 14 animal assisted therapy (AAT) psychoeducational sessions (once-a-week, 60 minutes) + treatment as usual and control group: treatment as usual. Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. The investigators evaluated changes on functionality, ADHD-associated symptoms, attention and working memory at pre-treatment and post-treatment. Assessment included intelligence test, ADHD symptoms referred by parents and teacher's (Conners Rating Scale), attention measures (Conners Continuous Performance Test (CPT-3) and children's functioning (Children's Global Assessment Scale (CGAS)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were recruited from a community Child and Adolescent Mental Health Service and a Primary Health Care Center. And randomized in two groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: psychoeducationalThe experimental group carried out a total of 14 one-hour group sessions, on a weekly basis for 14 consecutive weeks. The groups were formed by 8 participants. Sessions included the participation of one certified therapy dog, one technician specialized in AAT and a psychologist. Participants received their usual treatment (pharmacological and/or individual and family cognitive-behavioral treatment). Intervention: All sessions: Establishment of structured routines and schedules to help the child organize and manage daily responsibilities. Positive reinforcement to reward and motivate desirable behaviors. Sessions 1-7: Impulsivity management techniques. Social skills training. Self-control techniques to identify and manage moments of impulsivity. Sessions 8-14: Reinforcement of attention and concentration through strategies such as dividing tasks into smaller, more manageable parts. Cognitive-behavioral therapy to work on self-esteem, self-control and problem solving. |
| Control Group | No intervention | –Treatment as usual (pharmacological and/or individual and family cognitive-behavioral treatment). |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 7 and 12 years old (included).
- Diagnosis of ADHD confirmed at the Child and Adolescent Mental Health Service.
- Intelligence quotient of 80 or higher.
- Delivery of the information sheet and signature of the informed consent.
Key exclusion criteria (4 listed)
- If in the initial interview they declared having allergy or fear of dogs.
- History of aggression towards animals.
- Co-morbidity with other disorders (conduct disorders, autism spectrum disorders, anxiety disorder or depression).
- If the treatment regimen was modified during the intervention period.
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 |
|---|---|---|
| psychoeducationalAlso: Animal Assisted TherapyA structured AAT program and usual treatment in Experimental group. | Other | Experimental Group |
Primary outcome
Change from baseline Children's Global Assessment Scale (CGAS) at 14 weeks.
Time frame: This scale was administered at baseline and at week 14
It is a numerical scale to rate the overall functioning of young people under 18 years of age. Scores range from 1 to 100. A higher score indicates better functioning.
Change from baseline Clinical Global Impression - Severity Scale (CGI-S) at 14 weeks
Time frame: This scale was administered at baseline and at week 14
Is an instrument for measuring symptom severity of patients with mental disorders. Uses a single item on a Likert scale of seven values from 1= "Normal, not at all ill" to 7= "Among the most extremely ill patients".
2 secondary outcomes
Change from baseline Wechsler Intelligence Scale for Children (WISC-IV) at 14 weeks.
Time frame: This scale was administered at baseline and at week 14
Change from baseline Conners' Continuous Performance Test 3rd Edition (Conners CPT 3) at 14 weks
Time frame: This test was administered at baseline and at week 14
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 15 Jul 2024.
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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
Institut Català de la Salut
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducational in people with Attention Deficit Disorder With Hyperactivity and Animal Assisted Therapy, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 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 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Children's Global Assessment Scale (CGAS) at 14 weeks. (time frame: This scale was administered at baseline and at week 14). 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?
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 15 Jul 2024.