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.
Adolescent mental health is a significant global concern, especially in low- and middle-income countries (LMICs) like North Macedonia and Moldova. Adolescents in LMICs face numerous challenges, including socio-economic stressors, adverse childhood experiences, and limited access to mental health services. Parenting interventions are one approach to reduce risk for poor adolescent mental health outcomes and family maltreatment. Systematic evaluation of parenting programs is essential for enhancing scalability and sustainability in low-resource settings. Building on prior research, the Family-Focused Adolescent \& Lifelong Health Promotion (FLOURISH) project aims to adapt, optimize, and evaluate a parenting intervention for adolescents aged 10-14 and their caregivers in North Macedonia and Moldova. The project focuses on improving adolescent mental health and well-being in both teens and caregivers, and it is implemented according to the Multiphase Optimization Strategy (MOST) framework. Phase 1 of the project assessed the feasibility and cultural adaptation of the PLH for Parents and Teens program. In Phase 2, a multi-country factorial trial tested different combinations of three additional components (adolescent mental health tools from UNICEF's Helping Adolescents Thrive comics, adolescent peer support, and engagement boosters) and identified the optimized intervention package. This protocol describes the evaluation (Phase 3) of the optimized FLOURISH intervention package. The randomized waitlist controlled trial will recruit adolescent-caregiver pairs (320 to 340 families per country, 640 to 660 total) to test the effectiveness, cost-effectiveness, and scalability of the optimized PLH program. Families assigned to the intervention group will receive the program over seven weeks (one pre-program visit and six weekly group sessions), while families in the waitlist control group will receive the intervention after the six-month follow-up assessment. The results of this study will inform the potential for scaling up the optimized intervention at the national level in both countries and contribute robust evidence on adolescent mental health promotion in LMICs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,280
The 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.
Health For Youth Association
Chisinau, Moldova
RECRUITINGInstitute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje, North Macedonia
RECRUITINGChange 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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in adolescent health-related quality of life: EQ-5D-Y-3L
The EQ-5D-Y-3L is a standardized instrument designed to measure health-related quality of life in children and adolescents. It consists of five dimensions, each rated on a 3-point scale: no problems, some problems, severe problems. It also includes a visual analogue scale (VAS) 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 adolescents.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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).
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score
The WHO-5 includes 5 items rated from 0 (none of the time) to 5 (all of the time), assessing subjective well-being over the past 14 days. Scores range from 0 (lowest well-being) to 25 (highest well-being). Higher scores indicate greater well-being. It is completed by adolescents.
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Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scale (RCADS), depression and anxiety subscales, total score
The RCADS (adolescent self-report) consists of 25 items, each rated on a 4-point Likert scale (0 = never, 1 = sometimes, 2 = often, 3 = always). Item responses are summed to create separate scores for anxiety, depression, and a total score. Higher scores indicate greater anxiety, depressive symptoms, and overall emotional problems.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, subscales emotional regulation, problem-solving, interpersonal skills
The SEAL emotional regulation, problem-solving, interpersonal skills subscales include 7 items with responses "yes," "no," or "maybe." Higher scores indicate better socio-emotional skills. The questionnaire is completed by adolescents.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of bullying involvement in adolescents: Health Behaviour in School-aged Children (HBSC), peer violence subscale
The HBSC bullying module captures both traditional and cyber forms of bullying, including victimization and perpetration, over the past couple of months. It consists of 4 items covering bullying others, being bullied, cyberbullying perpetration, and cyberbullying victimization. Each item is scored on a 5-point scale: 0 = not in the past couple of months, 1 = once or twice, 2 = 2-3 times a month, 3 = about once a week, 4 = several times a week. Higher scores indicate greater involvement in bullying or cyberbullying. It is completed by adolescents.
Time frame: Pre-assessment and 6-month follow-up
Change in levels of parent-child communication in adolescents: Parent-Child Communication scale
The Parent-Child Communication scale (adolescent-report) consists of 7 items assessing the adolescent's ability to communicate feelings, problems, and beliefs with their caregiver. Items are rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate better communication between the adolescent and caregiver.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), emotional and affectionate subscales
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional and affectionate subscales together comprise 11 items. Higher scores indicate greater perceived social support. It is completed by adolescents.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in frequency of parenting practices in caregivers: Alabama Parenting Questionnaire (APQ), subscale corporal punishment
The APQ caregiver-report version measures frequency of disciplinary practices. Items are rated on a 5-point scale from 1 (never) to 5 (always). Higher scores on the corporal punishment subscale indicate greater use of punitive parenting practices. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in frequency of emotionally maltreating behaviors in caregivers: International Child Abuse Screening Tool (ICAST), emotional maltreatment subscale
This subscale consists of 5 items assessing psychologically aggressive behaviors toward the child in the past 4 weeks, including verbal aggression, emotional shaming, withdrawal, and threats of abandonment. Each item is scored on a 9-point frequency scale (0 = never to 8 = 8 or more times). Higher scores indicate greater frequency of emotional maltreatment.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of well-being in caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
The WHO-5 includes 5 items rated from 0 (none of the time) to 5 (all of the time), assessing subjective well-being over the past 14 days. Scores range from 0 (lowest well-being) to 25 (highest well-being). Higher scores indicate greater well-being. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of psychological distress in caregivers: Patient Health Questionnaire-9 (PHQ-9), total score
The PHQ-9 is a 9-item self-report tool for depressive symptom severity. Items are scored from 0 (not at all) to 3 (nearly every day). Higher scores indicate more depressive symptoms. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
The PSS is an 18-item self-report questionnaire rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater parental stress. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of loneliness in caregivers: Revised UCLA Loneliness Scale (RULS-6), total score
The RULS-6 consists of 6 items rated on a Likert scale (from 1 = never to 4 = always). Item responses are summed to create a total score ranging from 6 to 24, with higher scores indicating greater loneliness. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of social support in caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), emotional and affectionate subscales
The MOS-SSS emotional and affectionate subscales comprise 11 items. Scores range 1 (none of the time) to 5 (all of the time). Higher scores indicate more perceived social support. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), problem solving subscale
The problem solving subscale (6 items) assesses ability to resolve problems. Responses range from 1 (strongly agree) to 4 (strongly disagree). Higher scores indicate poorer functioning. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH), total score
The OxCAP-MH includes 16 items across domains such as social participation, emotional stability, and access to resources. Items are scored on a 5-point Likert scale. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)
The PECUNIA RUM assesses caregivers' use of residential care, non-residential health and social care, informal help, and work-related resources.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in caregiver-reported resource use in adolescents (caregiver-report): PECUNIA Resource Use Measurement (PECUNIA RUM)
The PECUNIA RUM proxy for adolescents records service use reported by caregivers, covering residential care, non-residential health and social care, and education.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of parent-child communication in caregivers: Parent-Child Communication Scale
The Parent-Child Communication Scale (caregiver-report) includes 7 items assessing caregiver perceptions of openness, emotional expressiveness, problem discussion, and perspective-taking in communication with their child. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores range from 7 to 35. Higher scores indicate more open, emotionally supportive, and bidirectional communication.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Change in levels of emotional and behavioral problems in adolescents (caregiver-report): Pediatric Symptom Checklist (PSC-17), externalizing and attention subscales, total score
The PSC-17 (caregiver-report) includes 17 items with a response range from 0 (never) to 2 (often), assessing overall psychosocial problems. The externalizing and attention subscales include 12 items. Higher scores indicate more emotional and behavioral problems.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up