Adolescent - Emotional ProblemFLOURISHNCT07240571
Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)
A study testing Optimized Parenting for Lifelong Health (PLH) for Parents and Teens in people with Adolescent - Emotional Problem and Parent Child Relationship, run by University of Klagenfurt at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent - Emotional Problem, Parent Child Relationship, Family Functioning
- What is being tested?
- Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Oct 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For Caregivers:
- 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 informed consent for both themselves and their adolescent
- For Adolescents:
Show all 9Show fewer
- Must be aged 10-14 at the baseline assessment
- Must provide assent to participate in the study
- Must have caregiver consent to participate.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Antonio Piolanti, Dr contact
2 sites in 2 countries
Moldova1 site, 1 recruiting
- Recruiting
Health For Youth Association
Chisinau
Galina Lesco, Dr., galina.lesco@gmail.com
Viorel Babii
North Macedonia1 site, 1 recruiting
- Recruiting
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje
Marija Raleva, Prof., marijaraleva@gmail.com
Slavica Gajdadzis-Knezhevikj, Dr.
About this study
Official title: Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe
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.
Read the detailed description
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.
- Conditions
- Adolescent - Emotional Problem, Parent Child Relationship, Family Functioning, Well-Being, Psychological
- Being tested
- Optimized Parenting for Lifelong Health (PLH) for Parents and Teens
- Keywords
- Multiphase Optimization Strategy (MOST), Family-based intervention, Adolescents, Mental health, Randomized trial
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized Parenting for Lifelong Health (PLH) for Parents and TeensBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized Parenting for Lifelong Health (PLH) for Parents and Teens | Experimental | 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. Receives: Behavioral: Optimized Parenting for Lifelong Health (PLH) for Parents and Teens |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Secondary outcomes (23)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start24 Oct 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Klagenfurt
- Sponsor type
- University, hospital or other
- Collaborators
- Health for Youth Association, Moldova, Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Cardiff University, Medical University of Vienna, Bielefeld University, University Jaume I Castellon, Association of Systemic Therapists Education Centre
- Responsible party
- Sponsor
- Investigators
- Heather M Foran, Prof, Principal investigator, University of KlagenfurtYulia Shenderovich, Dr, Principal investigator, Cardiff UniversityMarija Raleva, Principal investigator, Institute for Marriage, Family and Systemic Practice - ALTERNATIVAGalina Dr Lesco, Principal investigator, Health for Youth Association, MoldovaGraham Moore, Prof, Principal investigator, Cardiff UniversityRhiannon Evans, Prof, Principal investigator, Cardiff UniversityJudit Simon, Prof, Principal investigator, Medical University of ViennaNina Heinrichs, Prof, Principal investigator, Bielefeld University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240571
- Sponsor's protocol ID
- 20230135
- Acronym
- FLOURISH
- Status last verified
- May 2026
- First submitted
- 16 Nov 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mueller J, Sampathkumar S, Wienand D, Simon J, Piolanti A, Raleva M, Babii V, Kunovski I, Heinrichs N, Waller F, Shimbov B, Evans R, Moore G, Radloff M, Shenderovich Y, Foran HM. Evaluation of a family-focused intervention to promote adolescent mental health and family relationships (phase 3 of MOST): protocol for a randomised controlled trial. BMJ Open. 2026 Aug 17;16(8):e111877. doi: 10.1136/bmjopen-2025-111877.
PubMed 42608044
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe
- ClinicalTrials.gov ID
- NCT07240571
- Acronym / sponsor ID
- FLOURISH / 20230135
- Conditions
- Adolescent - Emotional Problem, Parent Child Relationship, Family Functioning, Well-Being, Psychological
- Keywords
- Multiphase Optimization Strategy (MOST), Family-based intervention, Adolescents, Mental health, Randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- University of KlagenfurtUniversity, hospital or other
- Collaborators
- Health for Youth Association, Moldova, Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Cardiff University, Medical University of Vienna, Bielefeld University, University Jaume I Castellon, Association of Systemic Therapists Education Centre
- Study start
- 24 Oct 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized Parenting for Lifelong Health (PLH) for Parents and Teens | Experimental | Behavioral: Optimized Parenting for Lifelong Health (PLH) for Parents and TeensFamilies 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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- For Caregivers:
- 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 informed consent for both themselves and their adolescent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized Parenting for Lifelong Health (PLH) for Parents and TeensThe 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. | Behavioural | Optimized Parenting for Lifelong Health (PLH) for Parents and Teens |
Primary outcome
Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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 adolescent health-related quality of life: EQ-5D-Y-3L
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
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.
23 secondary outcomes
Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
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
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
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
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
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
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
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
Time frame: Pre-assessment and 6-month follow-up
Change in levels of parent-child communication in adolescents: Parent-Child Communication scale
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
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
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
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
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
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
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
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
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
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
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)
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)
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
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
Time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 42608044Mueller J, Sampathkumar S, Wienand D, Simon J, Piolanti A, Raleva M, Babii V, Kunovski I, Heinrichs N, Waller F, Shimbov B, Evans R, Moore G, Radloff M, Shenderovich Y, Foran HM. Evaluation of a family-focused intervention to promote adolescent mental health and family relationships (phase 3 of MOST): protocol for a randomised controlled trial. BMJ Open. 2026 Aug 17;16(8):e111877. doi: 10.1136/bmjopen-2025-111877.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio Piolanti, Dr contact
Heather M Foran, Prof principal investigator
University of Klagenfurt
Yulia Shenderovich, Dr principal investigator
Cardiff University
Marija Raleva principal investigator
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized Parenting for Lifelong Health (PLH) for Parents and Teens in people with Adolescent - Emotional Problem and Parent Child Relationship, run by University of Klagenfurt at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Moldova, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather M Foran, Prof (+4346027001641, heather.foran@aau.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of emotional and behavioral problems in adolescents (caregiver report): Pediatric Symptom Checklist (PSC-17), internalizing subscale (time frame: Pre-assessment, 8-12 weeks after pre-assessment, and 6-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.