NCT07203469

Brief Summary

The goal of this action research project is to develop and implement nature- and activity-based group interventions across health care, school and leisure settings in Southern Norway. The interventions are tailored to support the mental health, self-efficacy and daily life functioning of children and youth in the Agder region, with a particular focus on youngsters who struggle due to neurodivergence, such as Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD) or Tourette's syndrome. The main questions we aim to answer are:

  1. 1.To what extent does nature- and activity-based outdoor education contribute to improvements in children's quality of life?
  2. 2.To what extent does nature- and activity-based interventions in a health care setting improve children's self-efficacy, self-esteem and quality of life?
  3. 3.Is there a difference in physiological reactions between nature-based provision of education or therapy and traditional indoor provision of education or therapy?

Trial Health

77
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress38%
Sep 2025Jun 2027

Study Start

First participant enrolled

September 1, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2027

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 16, 2025

Last Update Submit

October 1, 2025

Conditions

Keywords

Nature-basedAction researchchild and adolescent mental healthADHDAutismHealth-related quality of lifeoutdoor therapyexperiential educationheart rate variability

Outcome Measures

Primary Outcomes (3)

  • Quality of life (PhD 2)

    Operationalized as single items on hapiness, health, stress, outcome rating scale and KIDSCREEN-10

    Up to 12 months after a 10-week intervention

  • Health-related quality of life (PhD 1)

    Measured by KIDSCREEN-27

    Up to four weeks after a 12- week intervention

  • Physiological reactions

    Measured by heart rate and heart rate variability

    One day data collection during 12-week intervention. No follow-up.

Study Arms (3)

School setting (PhD 1)

ACTIVE COMPARATOR

In this study arm, we compare two approaches to nature-based experiential learning.

Behavioral: Universal approachBehavioral: Selective approach

Health Care Setting (PhD 2)

ACTIVE COMPARATOR

In this study arm, we compare two nature- and activity-based group treatments.

Behavioral: Outdoor therapyBehavioral: Climbing therapy

Heart Rate Variability (Substudy 1)

EXPERIMENTAL

Heart rate variability (HRV) is measured across contexts to explore physiological outcomes and stress levels

Behavioral: Universal approachBehavioral: Selective approachBehavioral: Outdoor therapyBehavioral: Climbing therapy

Interventions

In this intervention, the whole class participates in a 12-week nature-based experiential education program

Also known as: Universell Friluftslæring
Heart Rate Variability (Substudy 1)School setting (PhD 1)

In this intervention, an intentional group of pupils with an identified need is recruited from different classes within the same school to participate in a 12-week nature-based experiential education program

Also known as: Selektiv Friluftslæring
Heart Rate Variability (Substudy 1)School setting (PhD 1)
Outdoor therapyBEHAVIORAL

This intervention is a 10-week outdoor therapy group treatment that takes place in nearby nature

Also known as: Friluftsterapi, Basecamp
Health Care Setting (PhD 2)Heart Rate Variability (Substudy 1)

This intervention is a 10-week climbing therapy group treatment that takes place indoors in a climbing hall

Also known as: Klatreterapi
Health Care Setting (PhD 2)Heart Rate Variability (Substudy 1)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • In PhD 1, participants are recruited on class-level (all) or individual (identified need).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Child and Adolescent Mental Health (ABUP), Sørlandet Hospital HF

Kristiansand, Agder, 4630, Norway

RECRUITING

Department of Sport and Physical Education, University of Agder

Kristiansand, Agder, 4630, Norway

RECRUITING

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAutistic DisorderTourette Syndrome

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, PervasiveBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Carina R Fernee, PhD

    Sørlandet Hospital HF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina R Fernee, PhD

CONTACT

Sveinung Berntsen, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

October 2, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 15, 2027

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

It is not planned to share IPD, but we will consider each individual request for data sharing.

Locations