An interventional study of Optimized Parenting for Lifelong Health (PLH) for Parents and Teens in Adolescent - Emotional Problem, Parent Child Relationship and Family Functioning, sponsored by University of Klagenfurt. Recruiting at 2 sites in 2 countries. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Klagenfurt · Not applicable, Interventional, and Prevention
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.
A first version of this ClinicalTrials.gov record was completed in the PRS system on October 3, 2025, prior to participant recruitment. Due to disruptions related to the U.S. government shutdown affecting ClinicalTrials.gov processing during October/November 2025, there was a delay in public release of the record. Participant recruitment began on October 24, 2025.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 1,280 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
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Must be 18 years or older at baseline assessment
Must be the primary caregiver of an adolescent aged 10-14 who has resided in the same household for at least four nights a week in the past month
Must be able to speak at least one of the local languages in which the program will be offered (e.g., Macedonian, Romanian, Russian, Ukrainian or Albanian)
Must agree to participate in the program and provide for both themselves and their adolescent
For Adolescents:
Must be aged 10-14 at the baseline assessment
Must provide assent to participate in the study
Must have caregiver consent to participate.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Families assigned to this arm will receive the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program. The intervention is delivered in groups of approximately 10 adolescent-caregiver pairs over a 7-week period. It includes one pre-program visit and six weekly group sessions (about two hours each), with a mix of joint and separate sessions for caregivers and adolescents. Sessions are facilitated by trained professionals under ongoing supervision to ensure fidelity. The program focuses on strengthening family relationships, improving communication, managing emotions, problem-solving, and promoting positive parenting.
Behavioral: Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
Families assigned to this arm will not receive the intervention during the initial study period. They will complete all study assessments at baseline, post-intervention, and 6-month follow-up. After completion of the 6-month follow-up assessment, families in the waitlist control arm will be offered the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program under the same delivery format as the intervention group.
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.
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.
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.
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
Adolescent healthy weight: Body Mass Index (BMI), adolescent-report
BMI will be calculated from adolescent-reported mass (kg) and height (m).
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Adolescent healthy weight: Body Mass Index (BMI), caregiver-report
BMI will also be calculated from caregiver-reported adolescent mass (kg) and height (m).
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Fidelity of intervention delivery: PLH-Facilitator Assessment Tool (PLH-FAT)
The PLH-FAT evaluates fidelity of intervention delivery based on facilitator performance. It yields percentage scores on completion of intervention activities and demonstration of intervention skills. Higher percentages indicate greater fidelity.
Time frame: During intervention implementation (6-8 weeks)
Intervention costs
Intervention costs will include personnel time for training and delivery, organizational costs, materials, transportation, and consumables.
Time frame: During intervention implementation (6-8 weeks)
Caregiver-defined problems on the adolescent: Top Problems Assessment (TPA)
The TPA allows caregivers to identify their adolescent's three most pressing emotional or behavioral problems and rate each on a scale from 0 (not a problem) to 4 (a very big problem). Higher scores indicate greater severity of caregiver-identified problems.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Adolescent-defined problems: Top Problems Assessment (TPA)
The TPA allows adolescents to identify their three most important problems and rate each on a scale from 0 (not a problem) to 4 (a very big problem). Higher scores indicate greater severity of self-identified problems.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Attendance rate
Attendance will be assessed for: individual attendance, defined as the percentage of PLH sessions out of six attended separately by adolescents and caregivers; family attendance, defined as the percentage of PLH sessions out of six attended jointly by both adolescent and caregiver; and catch-up attendance, defined as the percentage of scheduled catch-up sessions attended out of six. Higher percentages indicate greater attendance.
Time frame: During intervention implementation (6-8 weeks)
Enrollment rate
Enrollment will be assessed as: individual enrollment, measured as the percentage of adolescents and caregivers who attended at least one PLH session; family enrollment, measured as the percentage of families in which both the adolescent and caregiver attended at least one PLH session. Higher percentages indicate greater enrollment.
Time frame: During intervention implementation (6-8 weeks)
Parenting among intervention staff: Alabama Parenting Questionnaire (APQ), involved and positive parenting subscales
The APQ is a self-report instrument of parenting practices. The involved and positive parenting subscales each assess positive caregiver behaviors such as engagement, attention, and supportive interactions. Items are rated on a 5-point scale ranging from 1 (never) to 5 (always). Higher scores indicate more positive and involved parenting practices.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Post-traumatic stress in adolescents: Children's Revised Impact of Event Scale (CRIES), total score, intrusion and avoidance subscales
The CRIES includes 8 items, scored on a 4-point scale (0 = not at all, 1 = rarely, 3 = sometimes, 5 = often). It provides a total score and two subscales: intrusion and avoidance. Higher scores indicate greater trauma-related distress. It is completed by adolescents.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Changes in levels of food insecurity in caregivers: Food Insecurity Experience Scale (FIES)
The FIES consists of 8 items assessing household experiences of food insecurity in the past 12 months, from worry about food availability to skipping meals or going a whole day without eating due to lack of money or resources. Items are scored yes (1) or no (0). Higher scores indicate more severe food insecurity. It is completed by caregivers.
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Plan to share: Yes — The project has a detailed data management plan (DMP) that defines data sharing procedures. The DMP was provided as a deliverable to the European Commission and is updated throughout the study funding period.
Supporting information: Study protocol
Time frame: After completion of the study and publication of the main results
Access criteria: Prof. Heather Foran is responsible for data management of the FLOURISH project. For information related to data sharing, please contact her at heather.foran@aau.at
Data sharing details ↗ · www.flourish-study.org
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 13 months after the start.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 13 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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University of Klagenfurt