NCT05384808

Brief Summary

The aim of the study is to investigate the needed extent and the way a dog is integrated into psychotherapeutic interventions for them to be motivating and alliance building for children and adolescents with psychiatric disorders aged 9 to 17 years old. Specifically, we want to elaborate if the dog needs to be integrated into the therapy in a form that it is part of the therapeutic context or if the presence of the dog without being part of the therapeutic context per se is beneficial.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Jun 2022Dec 2028

First Submitted

Initial submission to the registry

May 2, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

May 2, 2022

Last Update Submit

July 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Therapeutic alliance of patients

    Patient's reported therapeutic alliance is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the german adaptation of the "Therapeutic Alliance Scales for Children" (TASC)". The TASC consists of 12 items, answered with a 4 point likert scale. The questionnaire assesses the therapeutic alliance from the perception of the child. Four weeks after the fifth therapy session children will be asked to fill in the questionnaire again as follow-up measurement.

    9 weeks

  • Motivation of patients

    Patient's reported motivation is measured after the first, the third and the fifth therapy session of a newly began psychotherapy using the "Situational Motivation Scale for children (SMS-15)". The SMS-15 consists of 15 items answered with a 7 point likert scale. Four weeks after the fifth therapy session, children will be asked to fill in the questionnaire again as follow-up measurement.

    9 weeks

Secondary Outcomes (2)

  • Treatment satisfaction of patients

    4 weeks

  • Number of missed sessions

    5 weeks

Study Arms (3)

No dog present

EXPERIMENTAL

Conventional psychotherapy with no dog being present.

Behavioral: Standard Psychotherapy

Dog present and active part of therapeutic narrative.

EXPERIMENTAL

The dog is actively integrated into the therapeutic narrative.

Behavioral: Canine-assisted psychotherapy with dog actively integrated.

Dog present but not active part of therapeutic narrative.

EXPERIMENTAL

The dog is present but not actively integrated into the therapeutic narrative.

Behavioral: Canine-assisted psychotherapy with dog passively integrated.

Interventions

Participants receive a standard psychotherapy session with no dog being present.

No dog present

A dog is present and actively integrated into the therapeutic narrative.

Dog present and active part of therapeutic narrative.

A dog is present but not actively integrated into the therapeutic narrative.

Dog present but not active part of therapeutic narrative.

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age between 9 and 17 years
  • Children are seeing the therapist for the first time
  • Basic knowledge of child and parents in either German or English to be able to fill in questionnaires
  • Informed consent given by legal guardian
  • Positive or neutral attitude towards dogs

You may not qualify if:

  • acute psychosis; early childhood autism
  • fear of dogs
  • allergic reactions to dogs
  • reported aggressive behavior towards animals in the past
  • working with an own therapy dog
  • completed therapy training or if not completed far advanced therapy training under supervision
  • working with children and adolescents aged 9 to 17 years
  • not working with an own therapy dog
  • no completed or far advanced therapy training
  • not working with children and adolescents aged 9 to 17 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, Switzerland

RECRUITING

Related Publications (1)

  • Arnskotter W, Martin S, Walitza S, Hediger K. Effects of including a dog on treatment motivation and the therapeutic alliance in child and adolescent psychotherapy: study protocol for a randomized controlled trial. Trials. 2024 Jan 5;25(1):26. doi: 10.1186/s13063-023-07854-4.

Central Study Contacts

Karin Hediger, Prof. Dr.

CONTACT

Wanda Arnskötter, Msc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Karin Hediger

Study Record Dates

First Submitted

May 2, 2022

First Posted

May 20, 2022

Study Start

June 1, 2022

Primary Completion

March 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations