Actively Recruiting

Phase Not Applicable
Age: 10Years - 14Years
All Genders
Healthy Volunteers
NCT07240571

Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

Led by University of Klagenfurt · Updated on 2025-11-21

1280

Participants Needed

2

Research Sites

35 weeks

Total Duration

On this page

Sponsors

U

University of Klagenfurt

Lead Sponsor

H

Health for Youth Association, Moldova

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this study is to conduct a multi-country randomized waitlist controlled trial to evaluate the effectiveness, cost-effectiveness, and scalability of the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. In Phase 2 of the FLOURISH project, a factorial trial tested multiple intervention components and identified the optimized intervention package. In Phase 3, this trial will assess the implementation, outcomes, and economic impact of the optimized PLH program delivered to adolescents aged 10-14 and their caregivers. ALTERNATIVA will deliver the program in North Macedonia and the Health for Youth Association in the Republic of Moldova.

CONDITIONS

Official Title

Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)

Who Can Participate

Age: 10Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers must be 18 years or older at baseline assessment
  • Caregivers must be the primary caregiver of an adolescent aged 10-14 who has lived in the same household at least four nights a week in the past month
  • Caregivers must be able to speak at least one local language in which the program is offered (Macedonian, Romanian, Russian, Ukrainian, or Albanian)
  • Caregivers must agree to participate and provide informed consent for themselves and their adolescent
  • Adolescents must be aged 10-14 at baseline assessment
  • Adolescents must provide assent to participate
  • Adolescents must have caregiver consent to participate
Not Eligible

You will not qualify if you...

  • No formal exclusion criteria established
  • Participants experiencing acute distress or mental or physical health conditions interfering with participation may choose not to participate
  • Research team will provide referrals for participants unable to take part due to acute health issues

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Health For Youth Association

Chisinau, Moldova

Actively Recruiting

2

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, North Macedonia

Actively Recruiting

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Research Team

H

Heather M Foran, Prof

CONTACT

A

Antonio Piolanti, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH) | DecenTrialz