Adolescent - Emotional ProblemFLOURISHNCT06562244
Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
A study testing Parenting for Lifelong Health for Parents and Teens (PLH), Helping Adolescents Thrive comics and I Support My Friends in people with Adolescent - Emotional Problem and Parent-Child Relations, run by University of Klagenfurt at 1 site in North Macedonia.
Trial summary
The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the 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 Relations, Family Functioning
- What is being tested?
- Parenting for Lifelong Health for Parents and Teens (PLH), Helping Adolescents Thrive comics and I Support My Friends
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,316 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 21 Oct 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 the 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 (Romanian, Macedonian).
- Must agree to participate in the program. Must provide consent for both themselves and their child to participate in the study.
- For Adolescents:
- Must be aged 10-14 at the baseline assessment. Must assent to participate in the study. Must have caregiver consent to participate in the study.
Who cannot join
- No formal exclusion criteria have been established for the FLOURISH project. However, during the project 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 their participation. The decision will be made by the potential participant. If the participant decides they are unable to take part due to acute health issues, the research team will follow up and provide referrals to other services.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being: Protocol for a Multi-country Cluster Randomized Factorial Trial (FLOURISH Phase 2)
The aim of this study is to conduct a multi-country, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters.
ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova.
This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.
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 optimization 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 of the adapted parenting intervention, which included three components to enhance participation, retention, and effectiveness. The three components were UNICEF's Helping Adolescents Thrive (HAT) comics, peer support, and engagement boosters.
This protocol describes the optimization (Phase 2) of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT, adolescent peer support, and the engagement boosters, as well as their combinations. The factorial experiment will consist of eight conditions, stratified by country, with each condition reflecting a unique combination of the three components. The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project (Phase 3).
- Conditions
- Adolescent - Emotional Problem, Parent-Child Relations, Family Functioning, Well-Being, Psychological
- Being tested
- Parenting for Lifelong Health for Parents and Teens (PLH), Helping Adolescents Thrive comics, I Support My Friends
- 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.
Parenting for Lifelong Health for Parents and Teens (PLH)Behavioural
The PLH program is the core intervention and will be delivered over 6 sessions with adolescents and caregivers, focusing on building positive parent-child relationships, problem-solving skills, stress management, effective limit-setting, and emotional regulation. There will also be a pre-program visit with the facilitator and families prior to the group sessions. Sessions will include both separate and joint activities between adolescents and caregivers. Engagement boosters will be provided during the PLH sessions and are part of the PLH intervention.
Helping Adolescents Thrive comicsBehavioural
UNICEF's Helping Adolescents Thrive (HAT) comics will be used to guide adolescents through content on improving relationships, handling conflict, understanding emotions, and problem solving. These sessions will be group-based and cover the content in the HAT manual with the adolescents in an interactive format.
I Support My FriendsBehavioural
An adapted version of UNICEF's "I Support My Friends" program will be provided to adolescents by a facilitator in a group-based workshop format over the course of 1 day.
| Study group | Role | What they receive |
|---|---|---|
| HAT On, Peer Support On, High Engagement | Experimental | HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: Helping Adolescents Thrive comics; Behavioral: I Support My Friends |
| HAT On, Peer Support Off, High Engagement | Experimental | HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: Off
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: Helping Adolescents Thrive comics |
| HAT On, Peer Support On, Low Engagement | Experimental | HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: Low - Refreshments and certificates. Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: Helping Adolescents Thrive comics; Behavioral: I Support My Friends |
| HAT On, Peer Support Off, Low Engagement | Experimental | HAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building.
Peer Support: Off
Engagement booster: Low - Refreshments and certificates. Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: Helping Adolescents Thrive comics |
| HAT Off, Peer Support On, High Engagement | Experimental | HAT component: Off
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: I Support My Friends |
| HAT Off, Peer Support Off, High Engagement | Experimental | HAT component: Off
Peer Support: Off
Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH) |
| HAT Off, Peer Support On, Low Engagement | Experimental | HAT component: Off
Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support.
Engagement booster: Low - Refreshments and certificates. Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH); Behavioral: I Support My Friends |
| HAT Off, Peer Support Off, Low Engagement | Experimental | HAT component: Off
Peer Support: Off
Engagement booster: Low - Refreshments and certificates Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional support subscale", and Kidscreen-52, "peer and social support subscale"
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional support scale comprises 8 items. The Kidscreen-52, peers and social support subscale, includes 6 items with a response range from 1 (never) to 5 (always). This subscale assesses the quality of the child's relationships with peers and the support they receive from their social network.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
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. This scale has also been used as a single indicator to assess family functioning. The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Attendance rate
Attendance will be assessed as the percentage of group PLH sessions attended out of 6 (individual attendance for adolescents and caregivers)
Measured: During the implementation of the intervention (6 - 8 weeks)
Secondary outcomes (19)
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 will be completed by adolescents. The tools consists of 12 items with responses being scored using a 5-point Likert-type scale, from 1 (strongly disagree) to 5 (strongly agree).
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting" and "positive parenting" (parent- and child-report), and subscale "corporal punishment" (parent-report)
Parenting practices will be assessed with the child- and parent-report version of the Alabama Parenting Questionnaire (APQ). The APQ is a self-report measure of parenting behaviors designed to assess the parenting practices most related to disruptive behaviors of children. The APQ subscales may be rated by parents and children (caregiver-report and child-report) using a 5-point scale ranging from 1 (never) to 5 (always).
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
The UCLA-8 is brief 8-item version developed specifically for use with adolescents. Items are scored on 4-point scale.
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "affectionate subscale"
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The affectionate support subscale comprises 3 items.
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of well-being in adolescents and caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
The WHO-5 is a short, positively worded instrument designed to assess the level of emotional well-being over 14 days. Respondents are asked to rate how well each of the 5 statements applies to them when considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). Therefore, the raw score theoretically ranges from 0 (absence of well-being) to 25 (maximal well-being).
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
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 questionnaire used as a continuous measure to assess depressive symptom severity. Response options on the items range from 'not at all' (0 points) to 'nearly every day' (3 points).
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
The PSS is an 18-item self-report questionnaire. Items are rated on a 5-point Likert scale (1 = Strongly disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly agree) and scores range from 18 to 90, with higher values indicating greater levels of parental stress.
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score, "depression and anxiety subscales"
The RCADS requires respondents to rate how often each item applies to them. Items are scored 0-3 corresponding to ''never,'' ''sometimes,'' ''often,'' and ''always''.
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score
The RULS-6 was developed as a short 6-item version suitable for use among adults.
Measured: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of caregiver-reported behavior problems in adolescents: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales "rule-breaking and aggressive behavior, externalizing behavior"
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is a widely used instrument for assessing child behavioral and emotional symptoms.
Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of social support in caregivers: 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 support scales comprise 11 items.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), "problem solving and communication subscales"
The FAD measures changes in family functioning among caregivers. The problem solving subscale includes 6 items that assess the family's ability to resolve problems effectively. The communication subscale comprises 9 items that evaluate the clarity and directness of information exchange within the family. Responses for both subscales range from 1 (strongly agree) to 4 (strongly disagree).
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of emotional problems in adolescents: Pediatric Symptom Checklist (PSC), adolescent and caregiver report, total score, "internalizing, externalizing and attention subscales"
The PSC includes 17 items with a response range from 0 (never) to 2 (often), assessing emotional problems in adolescents. The checklist includes subscales for internalizing problems, externalizing problems, and attention problems.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, "emotional regulation, stress management, problem-solving, interpersonal skills, and self-esteem subscales"
The subscales include 11 items with responses ranging from "yes" to "no" and "maybe".
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in adolescent health-related quality of life: EQ-5D-Y-3L
The EQ-5D-Y-3L is a standardized instrument developed to measure health-related quality of life, particularly in younger populations. It includes five distinct dimensions that assess various aspects of the respondent's health. The tool includes 5 items, each with 3 response levels: no problems, some problems, and severe problems. Additionally, it includes a visual analogue scale (VAS) where respondents rate their overall health on a scale from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
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 includes five distinct dimensions that assess various aspects of the respondent's health. The tool includes 5 items, each with 5 response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Additionally, it includes a visual analogue scale (VAS) where respondents rate their overall health on a scale from 0 to 100, with 0 representing the worst imaginable health and 100 representing the best imaginable health.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH)
The OxCAP-MH includes 16 items assessing various dimensions of well-being and functioning, such as social participation, emotional stability, and access to resources. Response options include a 5-point Likert scale.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)
The PECUNIA RUM assesses resource use through different modules such as residential care, non-residential health and social care, informal help and work.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver-reported resource use in adolescents: PECUNIA Resource Use Measurement (PECUNIA RUM) proxy for adolescents
The PECUNIA RUM proxy for adolescents assesses resource use by adolescents through caregiver report, and cover modules such as residential care, non-residential health and social care, and education.
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start21 Oct 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
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
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Klagenfurt
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Cardiff University, Association for Systematic Therapy Education Center, Medical University of Vienna, University Jaume I Castellon, Bielefeld University, Health for Youth Association, Moldova
- Responsible party
- Sponsor
- Investigators
- Heather M Foran, Prof, Principal investigator, University of KlagenfurtYulia Shenderovich, Dr, Principal investigator, Cardiff UniversityMarija Raleva, Prof, Principal investigator, Institute for Marriage, Family and Systemic Practice - ALTERNATIVAGalina Lesco, Dr., 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
- NCT06562244
- Sponsor's protocol ID
- 1010955282
- Acronym
- FLOURISH
- Status last verified
- May 2026
- First submitted
- 16 Aug 2024
- 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
Piolanti A, Mueller J, Waller F, Heinrichs N, Simon J, Shenderovich Y, Sampathkumar S, Wienand D, Raleva M, Kunovski I, Babii V, Zhao X, Moore G, Foran HM. Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2). BMJ Open. 2025 Feb 7;15(2):e094085. doi: 10.1136/bmjopen-2024-094085.
PubMed 39920046
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
- A Family-focused Intervention Program to Foster Adolescent Mental Health and Well-being: Protocol for a Multi-country Cluster Randomized Factorial Trial (FLOURISH Phase 2)
- ClinicalTrials.gov ID
- NCT06562244
- Acronym / sponsor ID
- FLOURISH / 1010955282
- Conditions
- Adolescent - Emotional Problem, Parent-Child Relations, Family Functioning, Well-Being, Psychological
- Keywords
- Multiphase Optimization Strategy (MOST), Family-based intervention, Adolescents, Mental health, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,316 participants (actual)
- Lead sponsor
- University of KlagenfurtUniversity, hospital or other
- Collaborators
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Cardiff University, Association for Systematic Therapy Education Center, Medical University of Vienna, University Jaume I Castellon, Bielefeld University, Health for Youth Association, Moldova
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 20 Aug 2024 (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, cluster-randomized factorial trial to optimize the Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. Specifically, this trial will evaluate the effectiveness and cost consequences of three additional intervention components: UNICEF's Helping Adolescents Thrive comics, adolescent peer support based on UNICEF's I Support My Friends intervention, and engagement boosters.
ALTERNATIVA will deliver the program in North Macedonia and Health for Youth Association in the Republic of Moldova.
This trial is implemented according to the Multiphase Optimization Strategy (MOST). MOST involves three phases. The preparation phase involves adapting and piloting the intervention (Phase 1). The optimization phase involves a factorial trial (Phase 2). Finally, the evaluation phase involves conducting a randomized controlled trial to assess the optimized intervention's effectiveness and cost-effectiveness (Phase 3). A Phase 2 factorial trial is the focus of this registration.
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 optimization 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 of the adapted parenting intervention, which included three components to enhance participation, retention, and effectiveness. The three components were UNICEF's Helping Adolescents Thrive (HAT) comics, peer support, and engagement boosters.
This protocol describes the optimization (Phase 2) of the adapted FLOURISH intervention package which will assess the effectiveness and costs of HAT, adolescent peer support, and the engagement boosters, as well as their combinations. The factorial experiment will consist of eight conditions, stratified by country, with each condition reflecting a unique combination of the three components. The results of this study will be used to select the optimized intervention package which will be tested in a randomized trial in the next phase of the FLOURISH project (Phase 3).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HAT On, Peer Support On, High Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: Helping Adolescents Thrive comics, Behavioral: I Support My FriendsHAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building. Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support. Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). |
| HAT On, Peer Support Off, High Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: Helping Adolescents Thrive comicsHAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building. Peer Support: Off Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). |
| HAT On, Peer Support On, Low Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: Helping Adolescents Thrive comics, Behavioral: I Support My FriendsHAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building. Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support. Engagement booster: Low - Refreshments and certificates. |
| HAT On, Peer Support Off, Low Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: Helping Adolescents Thrive comicsHAT component: On - Two interactive sessions using UNICEF's Helping Adolescents Thrive comics, covering recognizing emotions, stress management, conflict resolution, and relationship building. Peer Support: Off Engagement booster: Low - Refreshments and certificates. |
| HAT Off, Peer Support On, High Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: I Support My FriendsHAT component: Off Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support. Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). |
| HAT Off, Peer Support Off, High Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)HAT component: Off Peer Support: Off Engagement booster: High - Includes refreshments, certificates, and vouchers (10 EUR for adolescents, 5 EUR for caregivers). |
| HAT Off, Peer Support On, Low Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH), Behavioral: I Support My FriendsHAT component: Off Peer Support: On - Half-day workshop from UNICEF's "I Support My Friends" program, teaching adolescents to identify distress in peers, develop listening skills, and seek additional support. Engagement booster: Low - Refreshments and certificates. |
| HAT Off, Peer Support Off, Low Engagement | Experimental | Behavioral: Parenting for Lifelong Health for Parents and Teens (PLH)HAT component: Off Peer Support: Off Engagement booster: Low - Refreshments and certificates |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Must be 18 years or older at the 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 (Romanian, Macedonian).
- Must agree to participate in the program. Must provide consent for both themselves and their child to participate in the study.
- Must be aged 10-14 at the baseline assessment. Must assent to participate in the study. Must have caregiver consent to participate in the study.
Key exclusion criteria (1 listed)
- No formal exclusion criteria have been established for the FLOURISH project. However, during the project 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 their participation. The decision will be made by the potential participant. If the participant decides they are unable to take part due to acute health issues, the research team will follow up and provide 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 |
|---|---|---|
| Parenting for Lifelong Health for Parents and Teens (PLH)The PLH program is the core intervention and will be delivered over 6 sessions with adolescents and caregivers, focusing on building positive parent-child relationships, problem-solving skills, stress management, effective limit-setting, and emotional regulation. There will also be a pre-program visit with the facilitator and families prior to the group sessions. Sessions will include both separate and joint activities between adolescents and caregivers. Engagement boosters will be provided during the PLH sessions and are part of the PLH intervention. | Behavioural | HAT Off, Peer Support Off, High Engagement, HAT Off, Peer Support Off, Low Engagement, HAT Off, Peer Support On, High Engagement, HAT Off, Peer Support On, Low Engagement, HAT On, Peer Support Off, High Engagement, HAT On, Peer Support Off, Low Engagement, HAT On, Peer Support On, High Engagement, HAT On, Peer Support On, Low Engagement |
| Helping Adolescents Thrive comicsUNICEF's Helping Adolescents Thrive (HAT) comics will be used to guide adolescents through content on improving relationships, handling conflict, understanding emotions, and problem solving. These sessions will be group-based and cover the content in the HAT manual with the adolescents in an interactive format. | Behavioural | HAT On, Peer Support Off, High Engagement, HAT On, Peer Support Off, Low Engagement, HAT On, Peer Support On, High Engagement, HAT On, Peer Support On, Low Engagement |
| I Support My FriendsAn adapted version of UNICEF's "I Support My Friends" program will be provided to adolescents by a facilitator in a group-based workshop format over the course of 1 day. | Behavioural | HAT Off, Peer Support On, High Engagement, HAT Off, Peer Support On, Low Engagement, HAT On, Peer Support On, High Engagement, HAT On, Peer Support On, Low Engagement |
Primary outcome
Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The CBCL is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). Each problem item is rated 0=not true, 1=somewhat or sometimes true, and 2=very true or often true. Standardized scores can be computed with higher scores indicating more problems.
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional support subscale", and Kidscreen-52, "peer and social support subscale"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The MOS-SSS includes 18 items with a response range from 1 (none of the time) to 5 (all of the time). The emotional support scale comprises 8 items. The Kidscreen-52, peers and social support subscale, includes 6 items with a response range from 1 (never) to 5 (always). This subscale assesses the quality of the child's relationships with peers and the support they receive from their social network.
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The general functioning subscale is one of the dimensions of the FAD and will be completed by caregivers. This scale has also been used as a single indicator to assess family functioning. The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.
Attendance rate
Time frame: During the implementation of the intervention (6 - 8 weeks)
Attendance will be assessed as the percentage of group PLH sessions attended out of 6 (individual attendance for adolescents and caregivers)
19 secondary outcomes
Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting" and "positive parenting" (parent- and child-report), and subscale "corporal punishment" (parent-report)
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "affectionate subscale"
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of well-being in adolescents and caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9), total score
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score, "depression and anxiety subscales"
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score
Time frame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
Change in levels of caregiver-reported behavior problems in adolescents: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales "rule-breaking and aggressive behavior, externalizing behavior"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of social support in caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional and affectionate subscales"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of family functioning in caregivers: Family Assessment Device (FAD), "problem solving and communication subscales"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of emotional problems in adolescents: Pediatric Symptom Checklist (PSC), adolescent and caregiver report, total score, "internalizing, externalizing and attention subscales"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in adolescent socio-emotional skills: Social Emotional Abilities and Learning (SEAL) Tool, "emotional regulation, stress management, problem-solving, interpersonal skills, and self-esteem subscales"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in adolescent health-related quality of life: EQ-5D-Y-3L
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver health-related quality of life: EQ-5D-5L
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH)
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in caregiver-reported resource use in adolescents: PECUNIA Resource Use Measurement (PECUNIA RUM) proxy for adolescents
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 39920046Piolanti A, Mueller J, Waller F, Heinrichs N, Simon J, Shenderovich Y, Sampathkumar S, Wienand D, Raleva M, Kunovski I, Babii V, Zhao X, Moore G, Foran HM. Family-focused intervention programme to foster adolescent mental health and well-being: protocol for a multicountry cluster randomised factorial trial (FLOURISH Phase 2). BMJ Open. 2025 Feb 7;15(2):e094085. doi: 10.1136/bmjopen-2024-094085.
- 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. This study is not recruiting at the moment.
Heather M Foran, Prof principal investigator
University of Klagenfurt
Yulia Shenderovich, Dr principal investigator
Cardiff University
Marija Raleva, Prof principal investigator
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenting for Lifelong Health for Parents and Teens (PLH), Helping Adolescents Thrive comics and I Support My Friends in people with Adolescent - Emotional Problem and Parent-Child Relations, run by University of Klagenfurt at 1 site in North Macedonia.
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 6 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: finished, 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 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale" (time frame: Pre-assessment and 6 - 8 weeks after pre-assessment). The study lists 4 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 NCT06562244, 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.