NCT05670990

Brief Summary

Due to an increasing amount of children and adolescents are suffering from mental illnesses i Sweden. Early preventive psychological interventions are important to avoid a long-time use of medicines. Animal assisted therapy and especially equine assisted services (EAS) has shown to be a good complementary method to decrease anxiety and/or depression in children and adolescents. The main aim is to study the effect of a specific EAS program regarding symptoms of mental illness and in long-term follow-up of future healthcare consumption. We will conduct interviews with both participants and their parents besides the questionnaires at follow-ups (12 weeks, and 1 year) The intervention will be EAS at a farm following a detailed program, the staff at the farm are specially trained with a certification to practice EAS. Each session will last for about 60 minutes, once a week. Participants will get information of the study by the child and youth psychiatry in the region of Skane, and from student´s health team at elementary schools. Those who want ti participate will contact the study coordinator for full information and informed consent. The EAS model has been used in treatment of adult with mental illness for many years, and the result are very positive. This project provides an opportunity to evaluate the effect of EAS to promote health and prevent severe manifest mental illness among children and adolescents. There are no previous studies of the long-term effect of EAS regarding health consumption.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

January 29, 2024

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 2, 2023

Last Update Submit

January 26, 2024

Conditions

Keywords

Equine-Assisted Therapy

Outcome Measures

Primary Outcomes (6)

  • Change in mood and feelings

    The Mood and Feelings Questionnaire, Swedish version: Short Form. 13 statements with 3 alternatives; Incorrect, Sometimes, Correct. Proportion of participants who change their answer between measuring points Both child and caregiver fill out the form

    1 time each week during 14 weeks and after 12 months

  • Mindfulness

    Child Acceptance and Mindfulness Measure, Swedish version, 10 statements that shall be graded in five step scale from Never to Always. Proportion of participants who change their answer between measuring points

    at baseline after 14 weeks and after 12 moths

  • Resilience

    Resilience scale, Swedish version, is a 7 graded Likert scale from Incorrect to correct, that consists of 25 statements Proportion of participants who changes their score on the scale between measuring points

    Baseline, after 12 weeks and after 12 months

  • Anxiety

    Spence Children's Anxiety Scale Swedish version, 45 statements with 4 alternatives; Never, Sometimes, Often, Always. Proportion of participants who change the score on the scale between measuring points

    At baseline after 14 weeks and after 12 months

  • Strengths and difficulties

    Strength and Difficulties Swedish version, 25 statements with 3 alternatives; Incorrect, somewhat correct, Correct Proportion of participants who change their score on the scale between measuring points

    At baseline, after 12 weeks and after 12 months.

  • Photovoice

    The participants will take photos by a digital camera or their own cellphone. The photos will be a starting point for a qualitative interview with each participant. Each participant will take 20 photos with a specific significant of their experience of equine assisted therapy. The following interview will be based on their photos.

    12 weeks after intervention start i.e. when the intervention ends.

Secondary Outcomes (1)

  • Compliance to intervention

    during the 12 weeks of intervention

Study Arms (2)

Equine assisted therapy

EXPERIMENTAL

once a week during 10 weeks the children will come to "Humlamaden" which is a horse farm with special trained horses and employees with specialist education in psychiatric care. During the time at the farm the child will go through a structured program that starts at the first time with just resting on the horse back under blankets

Other: Equine assisted therapy

Control

NO INTERVENTION

This group will receive treatment as usual and consist of those who is randomized to control group.

Interventions

A structured program that has been developed under several years at "Humlamaden" horse farm, for further information see under the description of the experimental group.

Equine assisted therapy

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 7 to 17
  • Depression
  • Anxiety
  • School refusers
  • Eating disorders
  • Established contact with the child and youth psychiatry in the region of Skane
  • Established contact wit the student´s health team at elementary schools in the region of Skane

You may not qualify if:

  • Severe allergy to horses
  • Do not speak, or do not understand Swedish, spoken and written.
  • Do not speak, or do not understand English spoken and written.
  • Those who cannot understand the intervention
  • Those who do not understand what it means to be in control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halmstad University

Halmstad, Högskolan I Halmstad, 30118, Sweden

Location

Related Publications (13)

  • Hoagwood KE, Acri M, Morrissey M, Peth-Pierce R. Animal-Assisted Therapies for Youth with or at risk for Mental Health Problems: A Systematic Review. Appl Dev Sci. 2017;21(1):1-13. doi: 10.1080/10888691.2015.1134267. Epub 2016 Jan 25.

    PMID: 28798541BACKGROUND
  • O'Haire ME. Animal-assisted intervention for autism spectrum disorder: a systematic literature review. J Autism Dev Disord. 2013 Jul;43(7):1606-22. doi: 10.1007/s10803-012-1707-5.

    PMID: 23124442BACKGROUND
  • Wilson K, Buultjens M, Monfries M, Karimi L. Equine-Assisted Psychotherapy for adolescents experiencing depression and/or anxiety: A therapist's perspective. Clin Child Psychol Psychiatry. 2017 Jan;22(1):16-33. doi: 10.1177/1359104515572379. Epub 2016 Jul 27.

    PMID: 26668260BACKGROUND
  • Schultz PN, Remick-Barlow GA, Robbins L. Equine-assisted psychotherapy: a mental health promotion/intervention modality for children who have experienced intra-family violence. Health Soc Care Community. 2007 May;15(3):265-71. doi: 10.1111/j.1365-2524.2006.00684.x.

    PMID: 17444990BACKGROUND
  • Dimitrijevic I. Animal-assisted therapy--a new trend in the treatment of children and adults. Psychiatr Danub. 2009 Jun;21(2):236-41.

    PMID: 19556955BACKGROUND
  • Lee PT, Dakin E, McLure M. Narrative synthesis of equine-assisted psychotherapy literature: Current knowledge and future research directions. Health Soc Care Community. 2016 May;24(3):225-46. doi: 10.1111/hsc.12201. Epub 2015 Mar 2.

    PMID: 25727575BACKGROUND
  • Bachi K, Terkel J, Teichman M. Equine-facilitated psychotherapy for at-risk adolescents: the influence on self-image, self-control and trust. Clin Child Psychol Psychiatry. 2012 Apr;17(2):298-312. doi: 10.1177/1359104511404177. Epub 2011 Jul 14.

    PMID: 21757481BACKGROUND
  • Beebe LH, Tian L, Morris N, Goodwin A, Allen SS, Kuldau J. Effects of exercise on mental and physical health parameters of persons with schizophrenia. Issues Ment Health Nurs. 2005 Jul;26(6):661-76. doi: 10.1080/01612840590959551.

    PMID: 16020076BACKGROUND
  • Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.

    PMID: 19012672BACKGROUND
  • Erdner A, Magnusson A. Caregivers' difficulties in activating long-term mental illness patients with low self-esteem. J Psychiatr Ment Health Nurs. 2012 Mar;19(2):140-5. doi: 10.1111/j.1365-2850.2011.01766.x. Epub 2011 Jun 22.

    PMID: 22070619BACKGROUND
  • Berget, B., et al., Animal-Assisted Therapy with Farm Animals for Persons with Psychiatric Disorders: Effects on Anxiety and Depression, a Randomized Controlled Trial. Occupational Therapy in Mental Health, 2011. 27(1): p. 50-64.

    BACKGROUND
  • Holmes, C.M.P., Goodwin, D., Redhead, E.S. et al. The Benefits of Equine-Assisted Activities: An Exploratory Study. Child Adolesc Soc Work J 29, 111-122 (2012). https://doi.org/10.1007/s10560-011-0251-z

    BACKGROUND
  • Punzo K, Skoglund M, Carlsson IM, Jormfeldt H. Experiences of an Equine-Assisted Therapy Intervention among Children and Adolescents with Mental Illness in Sweden - A Nursing Perspective. Issues Ment Health Nurs. 2022 Dec;43(12):1080-1092. doi: 10.1080/01612840.2022.2126571. Epub 2022 Sep 30.

    PMID: 36178465BACKGROUND

Related Links

MeSH Terms

Conditions

Neurodevelopmental DisordersAnxiety DisordersDepressionAnorexia Nervosa

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorFeeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Peter Nymberg, PhD

    Halmstad University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The investigators are not involved in recruitment of the participants, and have connections to them in a roll such as employees at the recruiting locations.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The randomization will take place after informed consent has been given. To achieve balance between the two groups (horse-assisted therapy or no horse-assisted therapy) we will use a minimization, so important prognostic factors are evenly distributed between the two study groups, as minimization variables we will use biological sex, age and whether the participants have contact with the child and youth psychiatry or not.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

March 1, 2023

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

January 29, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

This is under consideration, maybe sharing after contact with PI.

Locations