Family-Focused Adolescent & Lifelong Health Promotion

NCT ID: NCT05930535

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2024-01-27

Brief Summary

The aim of this study is to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.

The intervention and training materials will be adapted for the local context and languages (Romanian, Macedonian, and Russian). Facilitators and coaches will be trained to deliver the intervention in the fall of 2023. A pre-post pilot study will be conducted testing the feasibility of the program and the assessment measures with caregivers (30 per country) and their 10-14-year-old children (30 per country). This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' behavioral and emotional problems.

This feasibility study is part of a larger implementation science project using the MOST framework (Multiphase Optimization Strategy). This specific protocol is for the preparation phase of MOST (Phase 1). There are two more phases of MOST that will follow: the optimization phase (Phase 2) and the evaluation phase (Phase 3). The results of Phase 1 will be used to inform any changes to the intervention and assessment measures that may be necessary before testing the intervention in Phase 2, which will involve a randomized factorial trial.

Detailed Description

Mental health problems during early adolescence are a global concern, especially in low- and middle-income countries (LMICs). North Macedonia and the Republic of Moldova are among the poorest countries in Europe and many children in these countries are exposed to risk factors for negative mental health outcomes, such as family violence. In addition, the recent coronavirus pandemic and war in Ukraine have greatly increased economic, social, and psychological challenges in Eastern Europe. This situation makes the prevention of mental health problems and promotion of well-being among adolescents in North Macedonia and Republic of Moldova a high priority.

Parenting programs are recommended by many health guidelines as evidence-based solutions to support adolescent well-being. One example of a program developed specifically for low- and middle-income contexts is Parenting for Lifelong Health (PLH), a group-based social-behavioral intervention. However, a major challenge of implementing such programs entails sustaining and embedding them into lasting delivery systems (scaling-up). As a result, it is critical to optimize parenting programs in low-resource settings. Specifically, it is essential to identify the most effective and cost-effective components of parenting programs.

The present project, "FLOURISH", aims to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) and the Helping Adolescents Thrive (HAT) Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.

FLOURISH will consist of one clinical study with three phases (studies will be registered separately) based on the MOST framework:

Phase 1: Program adaptation and piloting (Preparation of MOST)

Phase 2: Factorial trial and process evaluation (Optimization of MOST)

Phase 3: Hybrid implementation-effectiveness randomized trial and process evaluation (Evaluation of MOST).

This protocol is for the Preparation phase of MOST and will inform the subsequent phases of the project. It consists of a pre-post evaluation testing the feasibility of the program with 30 caregivers and their children aged 10-14 years old in each country site and examining outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' mental health and family well-being.

The PLH for Parents and Teens program will include an adolescent peer support component and adolescent participation boosters, which are candidate components for testing in Phase 2. The peer support component will introduce a systematic strategy of social support enhancement in each intervention group. Each adolescent will pair up with another adolescent from their group.The adolescent participation boosters will involve a selection of incentives for participation that will be determined based on initial coproduction activities.

As an add-on to the PLH program and third candidate component to pilot in Phase 1, the Magnificent Mei comics as part of the Helping Adolescents Thrive materials will be provided to adolescents for at home practice. The comics consists of 6 chapters which cover the following topics: adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other. We will adapt the content together with UNICEF and the advisory groups.

In addition, all study materials will be adapted into the local languages (Romanian, Macedonian, and Russian). The assessment measures will be translated following a detailed translation script. This also includes intervention cost and other health economic measures for resource use (PECUNIA RUM), health-related quality of life (EQ5D-5L, EQ5D-Y(3L)) and capability well-being (OxCAP-MH) used to evaluate costs and outcomes for the cost effectiveness analyses in Phase 2. The initial psychometric results from a mini pilot (5 adolescents and 5 caregivers for each language), as well as the pre-post outcomes during this phase, will inform decisions on measures for Phase 2.

This study will also pilot a range of measures, reported by implementation staff, to record the time and resources required for intervention delivery, document the background and well-being of frontline intervention staff, and assess the fidelity of intervention delivery, using a structured observation tool.

The pilot feasibility study will be informed by other activities during this Phase. This include coproduction advisory groups with caregivers, adolescents, intervention staff, and professional experts, context-mapping expert interviews, and post-intervention focus-groups. These activities will be informative in assessing feasibility and acceptability of the intervention and context specific adaptations.

Conditions

Adolescent Behavior; Adolescent - Emotional Problem; Psychological Well-Being; Parent-Child Relations; Parenting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Parenting for Lifelong Health

Parenting Program "Parenting for Lifelong Health" (PLH) for parents and their teens aged 10-14 years old with Helping Adolescents Thrive comics at home

Group Type: EXPERIMENTAL

Parenting for Lifelong Health for Parents and Teens

Intervention Type: BEHAVIORAL

PLH will be delivered over 6 sessions as a group-based family program with both adolescents and caregivers attending, with joint and separate core sessions framed by joint introductions and endings. It will include activities such as: building positive parent-child relationships; developing problem-solving skills; stress-management and stress-reduction skills; improving effective limit-setting and discipline by parents; talking about feelings and regulating emotions.

The PLH program will also include a peer support component and incentive boosters. The Helping Adolescents Thrive comic chapters will be provided as homework activities. The comics, developed by UNICEF, cover adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other.

Interventions

Parenting for Lifelong Health for Parents and Teens

PLH will be delivered over 6 sessions as a group-based family program with both adolescents and caregivers attending, with joint and separate core sessions framed by joint introductions and endings. It will include activities such as: building positive parent-child relationships; developing problem-solving skills; stress-management and stress-reduction skills; improving effective limit-setting and discipline by parents; talking about feelings and regulating emotions.

The PLH program will also include a peer support component and incentive boosters. The Helping Adolescents Thrive comic chapters will be provided as homework activities. The comics, developed by UNICEF, cover adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. for Caregivers:

• Age 18 or older at baseline assessment;
• Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household at least four nights a week in the previous month;
• Able to speak at least one of the local languages in which the program will be offered (Romanian, Russian, Macedonian)
• Agreement to participate in the program;
• Provision of consent for self and child to participate in the study.

2. for Adolescents:

• Age 10-14 at baseline assessment;
• Assent to participate in the study;
• Caregiver consent to participate in the study.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

OTHER

Sponsor Role: collaborator

Health for Youth Association, Moldova

OTHER

Sponsor Role: collaborator

Cardiff University

OTHER

Sponsor Role: collaborator

Bielefeld University

OTHER

Sponsor Role: collaborator

Association for Systematic Therapy Education Center

UNKNOWN

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: collaborator

University Jaume I Castellon

UNKNOWN

Sponsor Role: collaborator

University of Klagenfurt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Foran, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Klagenfurt

Yulia Shenderovich, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Marija Raleva, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Galina Lesco, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Graham Moore, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Rhiannon Evans, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cardiff University

Nina Heinrichs, Prof.

Role: PRINCIPAL_INVESTIGATOR

Bielefeld University

Judit Simon, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Nevena Calovska, Prof.

Role: PRINCIPAL_INVESTIGATOR

Association of Systemic Therapists Education Centre

Bojan Shimbov, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Jaume I Castellon, Spain

Locations

Health For Youth Association

Chisinau, , Moldova

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, , North Macedonia

Countries

Moldova; North Macedonia

Other Identifiers

101095528

Identifier Type: -

Identifier Source: org_study_id