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.
None
No formal exclusion criteria have been established for the FLOURISH project. However, during the study introduction, the research team will guide participants through a consent form that asks whether they are currently experiencing acute distress or a mental or physical health condition that could interfere with participation. The decision to participate will be made by the individual. If a potential participant indicates they are unable to take part due to acute health issues, the research team will provide appropriate referrals to other services.
Parallel
Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
BehavioralThe optimized Parenting for Lifelong Health (PLH) for Parents and Teens program is a group-based parenting and adolescent skills training intervention. It will be delivered to adolescent-caregiver pairs (ages 10-14 and their primary caregivers) in groups of about 10 families. The program lasts 7 weeks and includes one pre-program visit and six weekly group sessions of approximately two hours each. Sessions include both joint and separate modules for caregivers and adolescents, focusing on building positive relationships, managing emotions, establishing routines, problem solving, and strengthening family communication. The program is facilitated by trained professionals who receive two days of training and ongoing weekly supervision.
Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale
The PSC-17 (caregiver-report) includes 17 items, with responses from 0 (never) to 2 (often) and assesses adolescents' psychosocial functioning. The internalizing subscale includes 5 items. Higher scores indicate more emotional problems.
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale general functioning
The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. It consists of 12 items. Scoring is on a 4-point scale (from 1 = strongly agree to 4 = strongly disagree). Higher scores indicate poorer family functioning.
Change in frequency of parenting practices in caregivers (caregiver-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting
Parenting practices will be assessed with the caregiver-report version of the APQ. The APQ is a self-report measure of parenting behaviors designed to assess practices most related to children's behavioral adjustment. Items are rated on a 5-point scale from 1 (never) to 5 (always). Higher scores on the involved and positive parenting subscales indicate more positive parenting practices. It is completed by caregivers.
Change in caregiver health-related quality of life: EQ-5D-5L
The EQ-5D-5L is a standardized instrument developed to measure health-related quality of life. It consists of five dimensions, each rated on a 5-point scale: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, it includes a visual analogue scale (VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health). Higher dimension scores indicate more health problems; higher VAS scores indicate better self-rated health. It is completed by caregivers.
Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
The CPA-YA measures parent-child communication apprehension and is completed by adolescents. Each item is scored on a 5-point Likert scale (0 = strongly agree to 4 = strongly disagree). Four items are reverse-coded so that all responses are oriented in the same direction. Higher scores indicate less communication apprehension (i.e., more ease and confidence in communicating with parents).
Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
The UCLA-8 is an 8-item scale designed for adolescents. Items are rated on a 4-point scale (1 = never to 4 = often). Higher scores indicate greater loneliness.
Change in frequency of parenting practices (adolescent-report): Alabama Parenting Questionnaire (APQ), subscales involved and positive parenting
The APQ adolescent-report version measures perceptions of parenting behaviors. Items are rated on a 5-point scale from 1 (never) to 5 (always). Higher scores on involved and positive parenting subscales indicate better parenting practices.
Change in levels of emotional and behavioral problems in adolescents (adolescent-report): Pediatric Symptom Checklist (PSC-17), internalizing, externalizing and attention subscales, total score
The PSC-17 (adolescent-report) includes 17 items with a response range from 0 (never) to 2 (often), assessing overall psychosocial problems. Higher scores indicate more emotional and behavioral problems.
Adolescent healthy weight: Body Mass Index (BMI), adolescent-report
BMI will be calculated from adolescent-reported mass (kg) and height (m).
Adolescent healthy weight: Body Mass Index (BMI), caregiver-report
BMI will also be calculated from caregiver-reported adolescent mass (kg) and height (m).
Post-traumatic stress in caregivers: PTSD Checklist for DSM-5 (PCL-5), short form, total score
The short form of the PCL-5 includes 4 items assessing PTSD symptom severity. Each item is scored from 0 (not at all) to 4 (extremely), with higher scores indicating greater PTSD symptoms. It is completed by caregivers.
Well-being among intervention staff: World Health Organization-Five Well-Being Index (WHO-5), total score
The WHO-5 is a brief measure of emotional well-being over the past 14 days. It includes 5 items scored from 0 (none of the time) to 5 (all of the time). Total scores range from 0 (absence of well-being) to 25 (maximum well-being). Higher scores indicate greater well-being. It is completed by intervention staff.
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University of Klagenfurt
Lead sponsor
Health for Youth Association, Moldova
Collaborator
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Collaborator
Cardiff University
Collaborator
Medical University of Vienna
Collaborator
Bielefeld University
Collaborator
University Jaume I Castellon
Collaborator
Association of Systemic Therapists Education Centre
Collaborator