Actively Recruiting

Phase Not Applicable
Age: 10Years - 14Years
All Genders
Healthy Volunteers
NCT06562244

Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial

Led by University of Klagenfurt · Updated on 2024-12-06

640

Participants Needed

1

Research Sites

31 weeks

Total Duration

On this page

Sponsors

U

University of Klagenfurt

Lead Sponsor

I

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Collaborating Sponsor

AI-Summary

What this Trial Is About

The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters. ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova. This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.

CONDITIONS

Official Title

Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial

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.
  • Caregivers must be the primary caregiver of an adolescent aged 10-14 who lives with them at least four nights a week.
  • Caregivers must speak Romanian or Macedonian.
  • Caregivers must agree to participate and provide consent for themselves and their child.
  • Adolescents must be aged 10-14 at baseline.
  • Adolescents must assent to participate and have caregiver consent.
Not Eligible

You will not qualify if you...

  • No formal exclusion criteria are established.
  • Participants currently experiencing acute distress or health conditions that interfere with participation may choose not to take part.
  • The research team will provide referrals for those unable to participate due to acute health issues.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Institute 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

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

PREVENTION

Number of Arms

8

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