Clinical trial NCT05930535: Family-Focused Adolescent & Lifelong Health Promotion
Official title: Family-Focused Adolescent & Lifelong Health Promotion - Study Protocol of Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Adolescent - Emotional Problem
Psychological Well-Being
Parent-Child Relations
Parenting
Keywords: Parenting
Mental health
MOST design
Adolescents
Family-based intervention
Lead sponsor: University of Klagenfurt
Sponsor class: OTHER
Collaborators: name: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Health for Youth Association, Moldova
name: Cardiff University
name: Bielefeld University
name: Association for Systematic Therapy Education Center
name: Medical University of Vienna
name: University Jaume I Castellon
First posted: 2023-07-05
Enrollment: 128
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be allocated to the same intervention arm for this pilot feasibility study.
Primary purpose: PREVENTION

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.

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.

Exclusion Criteria:

No formal exclusion criteria have been set for FLOURISH. However, during the process of introducing the project, the research team will guide the participants through a consent form that asks whether they are currently experiencing acute distress or a mental health or physical health condition that would interfere with their participation. The judgement will be made by the potential participant. If the participant decides they are not currently able to take part due to acute health issues, the research team will follow up and provide referrals for other services.

Primary outcomes:
measure: Change in levels of adolescent emotional problems: Revised Child Anxiety and Depression Scales (RCADS), subscales
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent emotional problems: Child Behavior Checklist (CBCL) 6-18, internalizing subscale
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent emotional problems: Youth Self-Report (YSR) 11-18, internalizing subscale
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales rule-breaking and aggressive behavior
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscales rule-breaking and aggressive behavior
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
Secondary outcomes:
measure: Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting", subscale "parental supervision/monitoring " (parent- and child-report) and subscale "corporal punishment" (parent-report)
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of social support in adolescents and caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional and affectionate subscales"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of well-being in caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscale externalizing behavior
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscale externalizing behavior
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
Other outcomes:
measure: Enrollment rate
timeFrame: During the implementation of the intervention (Six weeks)
measure: Attendance rate
timeFrame: During the implementation of the intervention (Six weeks)
measure: Adolescent healthy weight: BMI; adolescent and caregiver reports
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Caregiver alcohol use: The Alcohol Use Disorder Identification Test (AUDIT), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Post-traumatic stress in caregivers: PTSD checklist for DSM-5 (PCL-5), short form, total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Posttraumatic stress in adolescents: Children's Revised Impact of Event Scale (CRIES), total score and subscales
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Adolescent sexual risk behavior: Health Behavior in School-aged Children Study, sub-scale "sexual health"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Adolescent defined problems: The Top Problem Assessment
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Health For Youth Association
city: Skopje
country: North Macedonia
facility: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Study officials:
affiliation: University of Klagenfurt
name: Heather Foran, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Yulia Shenderovich, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Marija Raleva, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Galina Lesco, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Graham Moore, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Rhiannon Evans, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University
name: Nina Heinrichs, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Judit Simon, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Association of Systemic Therapists Education Centre
name: Nevena Calovska, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jaume I Castellon, Spain
name: Bojan Shimbov, Prof.
role: PRINCIPAL_INVESTIGATOR
References: