NCT07339696

Brief Summary

The aim of this study is to devise implementation strategies for the New Forest Parenting Programme (NFPP) to support a community implementation model (NFPP-CIM) and test its feasibility and acceptability for parents and stakeholders.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

February 15, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 14, 2026

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

November 14, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

ADHD parent training

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome (exploratory clinical signal): ADHD Rating Scale-IV (ADHD-RS-IV) Danish Version - parent ratings

    This outcome is included solely as an exploratory signal of change to inform the design of a future fully powered trial; the current study is not powered to detect statistically significant effects.The ADHD-RS is an 18-item questionnaire that addresses child symptoms of ADHD and symptoms of oppositional defiant disorder/conduct disorder on a four point scale ('not at all' to 'very often') (DuPaul, G.J., et al., Parent ratings of attention-deficit/hyperactivity disorder symptoms: Factor structure and normative data. Journal of Psychopathology and Behavioral Assessment, 1998. 20(1): p. 83-102.)

    Change in ADHD symptoms measured by ADHD-RS from baseline to post-intervention. I.e. From T1: enrolment (baseline) to T2: T2 (End of treatment): approximately 16 weeks after T1 to T3 (Follow-up): approximately 36 weeks after T2.

Secondary Outcomes (3)

  • The Strengths and Difficulties Questionnaire (SDQ) - Danish parent version

    Change in SDQ scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.

  • The Parenting Sense of Competence Scale (PSOC) Danish version - parent ratings

    Change in PSOC scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.

  • Family Strain Index (FSI) - parent ratings

    Change in FSI scores from baseline (T1) at enrollment, to post-intervention (T2) approximately 16 weeks after T1, and to follow-up (T3) approximately 36 weeks after T2.

Study Arms (1)

NFPP-CIM Implementation Group

The group includes families with children aged 3-12 years with ADHD or attention and activity difficulties, as well as community practitioners, managers, and other local stakeholders involved in delivering the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM). The study evaluates the feasibility, acceptability, and perceived outcomes of implementing NFPP-CIM in municipal child and family services.

Behavioral: New Forest Parenting Programme

Interventions

Parent training for children who has difficulties with attention and activity or ADHD

NFPP-CIM Implementation Group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population includes families receiving services through municipal child and family clinics in Denmark. Participating families have children aged 3-12 years who present with parent-perceived difficulties related to attention and activity regulation, including diagnosed or suspected ADHD. All custodial parents provide informed consent and complete the quantitative outcome measures. In addition, the study includes community practitioners, managers, and other stakeholders involved in delivering and supporting the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM). These participants complete semistructured interviews and contribute qualitative data related to feasibility, acceptability, and implementation processes and do not complete quantitative outcome questionnaires (see detailed study description).

You may qualify if:

  • Families receiving services through municipal child and family clinics in Denmark
  • Child aged 3-12 years
  • Parent-perceived difficulties with attention and activity regulation, including those with a diagnosis or suspected diagnosis of ADHD.
  • All custodial parents willing and able to provide informed consent
  • Parents interested in participating in the New Forest Parenting Programme - Community Implementation Model (NFPP-CIM)

You may not qualify if:

  • Families not receiving services through municipal child and family clinics
  • Parents unable to provide informed consent
  • Families unable to participate in the intervention due to severe child or family circumstances that preclude engagement (e.g. acute crisis requiring alternative services, Parents or children with severe mental or physical illness that would prevent active participation in the intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forskningsafdelingen - Børne- og Ungdomspsykiatrisk Afdeling, Psykiatrien-Skejby

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Alexandre, J.L., et al., The ADHD rating scale-IV preschool version: Factor structure, reliability, validity, and standardisation in a Danish community sample. Research in Developmental Disabilities, 2018. 78: p. 125-135. Arnfred, J., et al., Danish norms for the Strengths and Difficulties Questionnaire. Danish medical journal, 2019. 66(6). Borrelli, B., The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials. 2011. p. S52-S63. Bowen, D.J., et al., How we design feasibility studies. American journal of preventive medicine, 2009. 36(5): p. 452-457. Cohen, A.N., et al., Improving care quality through hybrid implementation/effectiveness studies: Best practices in design, methods, and measures. Implementation Science, 2015. 10(1): p. A29. Curran, G.M., et al., Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical care, 2012. 50(3): p. 217. Damschroder, L.J., et al., Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Science, 2009. 4(1): p. DuPaul, G.J., et al., Parent ratings of attention-deficit/hyperFactor structure and normative data. Journal of Psychopathology and Behavioral Assessment, 1998. 20(1): p. 83-102. Fixsen, D., et al., Statewide implementation of evidence-based programs. Exceptional children, 2013. 79(2): p. 213. Fixsen, D., et al., Statewide implementation of evidence-based programs. Exceptional Children, 2013. Goodman, R., et al., Using the Strengths and Difficulties Questionnaire (SDQ) to screen for child psychiatric disorders in a community sample. The British Journal of Psychiatry, 2000. 177(6): p. 534.

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Anne-Mette Lange

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

January 14, 2026

Study Start

February 15, 2022

Primary Completion

June 30, 2025

Study Completion

March 31, 2026

Last Updated

January 14, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to data protection regulations

Locations