Adolescent BehaviorFLOURISHNCT05930535
Family-Focused Adolescent & Lifelong Health Promotion
A study testing Parenting for Lifelong Health for Parents and Teens in people with Adolescent Behavior and Adolescent - Emotional Problem, run by University of Klagenfurt at 2 sites in 2 countries.
Trial summary
The aim of this study is to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Adolescent - Emotional Problem, Psychological Well-Being
- What is being tested?
- Parenting for Lifelong Health 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
- 128 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 Sep 2023to 27 Jan 2024
- 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:
- Age 18 or older at baseline assessment;
- Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household at least four nights a week in the previous month;
- Able to speak at least one of the local languages in which the program will be offered (Romanian, Russian, Macedonian)
- Agreement to participate in the program;
- Provision of consent for self and child to participate in the study.
Show all 10Show fewer
- for Adolescents:
- Age 10-14 at baseline assessment;
- Assent to participate in the study;
- Caregiver consent to participate in the study.
Who cannot join
- No formal exclusion criteria have been set for FLOURISH. However, during the process of introducing the project, the research team will guide the participants through a consent form that asks whether they are currently experiencing acute distress or a mental health or physical health condition that would interfere with their participation. The judgement will be made by the potential participant. If the participant decides they are not currently able to take part due to acute health issues, the research team will follow up and provide referrals for other services.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
North Macedonia1 site
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje
About this study
Official title: Family-Focused Adolescent & Lifelong Health Promotion - Study Protocol of Phase 1
The aim of this study is to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
The intervention and training materials will be adapted for the local context and languages (Romanian, Macedonian, and Russian). Facilitators and coaches will be trained to deliver the intervention in the fall of 2023. A pre-post pilot study will be conducted testing the feasibility of the program and the assessment measures with caregivers (30 per country) and their 10-14-year-old children (30 per country). This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' behavioral and emotional problems.
This feasibility study is part of a larger implementation science project using the MOST framework (Multiphase Optimization Strategy). This specific protocol is for the preparation phase of MOST (Phase 1). There are two more phases of MOST that will follow: the optimization phase (Phase 2) and the evaluation phase (Phase 3). The results of Phase 1 will be used to inform any changes to the intervention and assessment measures that may be necessary before testing the intervention in Phase 2, which will involve a randomized factorial trial.
Read the detailed description
Mental health problems during early adolescence are a global concern, especially in low- and middle-income countries (LMICs). North Macedonia and the Republic of Moldova are among the poorest countries in Europe and many children in these countries are exposed to risk factors for negative mental health outcomes, such as family violence. In addition, the recent coronavirus pandemic and war in Ukraine have greatly increased economic, social, and psychological challenges in Eastern Europe. This situation makes the prevention of mental health problems and promotion of well-being among adolescents in North Macedonia and Republic of Moldova a high priority.
Parenting programs are recommended by many health guidelines as evidence-based solutions to support adolescent well-being. One example of a program developed specifically for low- and middle-income contexts is Parenting for Lifelong Health (PLH), a group-based social-behavioral intervention. However, a major challenge of implementing such programs entails sustaining and embedding them into lasting delivery systems (scaling-up). As a result, it is critical to optimize parenting programs in low-resource settings. Specifically, it is essential to identify the most effective and cost-effective components of parenting programs.
The present project, "FLOURISH", aims to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) and the Helping Adolescents Thrive (HAT) Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
FLOURISH will consist of one clinical study with three phases (studies will be registered separately) based on the MOST framework:
Phase 1: Program adaptation and piloting (Preparation of MOST)
Phase 2: Factorial trial and process evaluation (Optimization of MOST)
Phase 3: Hybrid implementation-effectiveness randomized trial and process evaluation (Evaluation of MOST).
This protocol is for the Preparation phase of MOST and will inform the subsequent phases of the project. It consists of a pre-post evaluation testing the feasibility of the program with 30 caregivers and their children aged 10-14 years old in each country site and examining outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' mental health and family well-being.
The PLH for Parents and Teens program will include an adolescent peer support component and adolescent participation boosters, which are candidate components for testing in Phase 2. The peer support component will introduce a systematic strategy of social support enhancement in each intervention group. Each adolescent will pair up with another adolescent from their group.The adolescent participation boosters will involve a selection of incentives for participation that will be determined based on initial coproduction activities.
As an add-on to the PLH program and third candidate component to pilot in Phase 1, the Magnificent Mei comics as part of the Helping Adolescents Thrive materials will be provided to adolescents for at home practice. The comics consists of 6 chapters which cover the following topics: adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other. We will adapt the content together with UNICEF and the advisory groups.
In addition, all study materials will be adapted into the local languages (Romanian, Macedonian, and Russian). The assessment measures will be translated following a detailed translation script. This also includes intervention cost and other health economic measures for resource use (PECUNIA RUM), health-related quality of life (EQ5D-5L, EQ5D-Y(3L)) and capability well-being (OxCAP-MH) used to evaluate costs and outcomes for the cost effectiveness analyses in Phase 2. The initial psychometric results from a mini pilot (5 adolescents and 5 caregivers for each language), as well as the pre-post outcomes during this phase, will inform decisions on measures for Phase 2.
This study will also pilot a range of measures, reported by implementation staff, to record the time and resources required for intervention delivery, document the background and well-being of frontline intervention staff, and assess the fidelity of intervention delivery, using a structured observation tool.
The pilot feasibility study will be informed by other activities during this Phase. This include coproduction advisory groups with caregivers, adolescents, intervention staff, and professional experts, context-mapping expert interviews, and post-intervention focus-groups. These activities will be informative in assessing feasibility and acceptability of the intervention and context specific adaptations.
- Conditions
- Adolescent Behavior, Adolescent - Emotional Problem, Psychological Well-Being, Parent-Child Relations, Parenting
- Being tested
- Parenting for Lifelong Health for Parents and Teens
- Keywords
- Parenting, Mental health, MOST design, Adolescents, Family-based intervention
- Medical subject headings
- Adolescent Behavior, 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 TeensBehavioural
PLH will be delivered over 6 sessions as a group-based family program with both adolescents and caregivers attending, with joint and separate core sessions framed by joint introductions and endings. It will include activities such as: building positive parent-child relationships; developing problem-solving skills; stress-management and stress-reduction skills; improving effective limit-setting and discipline by parents; talking about feelings and regulating emotions.
The PLH program will also include a peer support component and incentive boosters. The Helping Adolescents Thrive comic chapters will be provided as homework activities. The comics, developed by UNICEF, cover adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other.
| Study group | Role | What they receive |
|---|---|---|
| Parenting for Lifelong Health | Experimental | Parenting Program "Parenting for Lifelong Health" (PLH) for parents and their teens aged 10-14 years old with Helping Adolescents Thrive comics at home Receives: Behavioral: Parenting for Lifelong Health for Parents and Teens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of adolescent emotional problems: Revised Child Anxiety and Depression Scales (RCADS), subscales
The RCADS is a self-report measure developed to evaluate among children symptoms of a number of DSM defined anxiety and depression disorders with two 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-assessment and 6 - 8 weeks after pre-assessment
Change in levels of adolescent emotional problems: 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 adolescent emotional problems: Youth Self-Report (YSR) 11-18, internalizing subscale
The YSR 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 adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales rule-breaking and aggressive 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 adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscales rule-breaking and aggressive behavior
The YSR is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). These YSR is widely used 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 well-being in adolescents: 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) with a range of scores from 0 (absence of well-being) to 25 (maximum score on well-being).
Measured: Pre-assessment and 6 - 8 weeks after pre-assessment
Secondary outcomes (12)
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 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
Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting", subscale "parental supervision/monitoring " (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-assessment and 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-assessment and 6 - 8 weeks after pre-assessment
Change in levels of social support in adolescents and 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 well-being in 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-assessment and 6 - 8 weeks after pre-assessment
Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9)
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-assessment and 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-assessment and 6 - 8 weeks after pre-assessment
Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score
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-assessment and 6 - 8 weeks after pre-assessment
Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscale externalizing behavior
The CBCL is an instrument within the Achenbach System of Empirically Based Assessment (ASEBA), which are widely used assessments for 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 adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscale externalizing behavior
The YSR is an instrument within the Achenbach System of Empirically Based Assessment (ASEBA), which are widely used assessments for 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 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-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 posted5 Jul 2023
- Study start18 Sep 2023
- Primary completion15 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be allocated to the same intervention arm for this pilot feasibility study.
- Masking
- None (open label)
- Enrolment
- 128 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, Health for Youth Association, Moldova, Cardiff University, Bielefeld University, Association for Systematic Therapy Education Center, Medical University of Vienna, University Jaume I Castellon
- Responsible party
- Sponsor
- Investigators
- Heather 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, Prof., Principal investigator, Cardiff UniversityGraham Moore, Prof., Principal investigator, Cardiff UniversityRhiannon Evans, Prof., Principal investigator, Cardiff UniversityNina Heinrichs, Prof., Principal investigator, Bielefeld UniversityJudit Simon, Prof., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930535
- Sponsor's protocol ID
- 101095528
- Acronym
- FLOURISH
- Status last verified
- May 2024
- First submitted
- 16 Jun 2023
- Last updated
- 16 May 2024
- 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 is provided as a deliverable to the European Commission and updated throughout the study funding period.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Focused Adolescent & Lifelong Health Promotion - Study Protocol of Phase 1
- ClinicalTrials.gov ID
- NCT05930535
- Acronym / sponsor ID
- FLOURISH / 101095528
- Conditions
- Adolescent Behavior, Adolescent - Emotional Problem, Psychological Well-Being, Parent-Child Relations, Parenting
- Keywords
- Parenting, Mental health, MOST design, Adolescents, Family-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of KlagenfurtUniversity, hospital or other
- Collaborators
- Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Health for Youth Association, Moldova, Cardiff University, Bielefeld University, Association for Systematic Therapy Education Center, Medical University of Vienna, University Jaume I Castellon
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 5 Jul 2023 (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 adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
The intervention and training materials will be adapted for the local context and languages (Romanian, Macedonian, and Russian). Facilitators and coaches will be trained to deliver the intervention in the fall of 2023. A pre-post pilot study will be conducted testing the feasibility of the program and the assessment measures with caregivers (30 per country) and their 10-14-year-old children (30 per country). This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' behavioral and emotional problems.
This feasibility study is part of a larger implementation science project using the MOST framework (Multiphase Optimization Strategy). This specific protocol is for the preparation phase of MOST (Phase 1). There are two more phases of MOST that will follow: the optimization phase (Phase 2) and the evaluation phase (Phase 3). The results of Phase 1 will be used to inform any changes to the intervention and assessment measures that may be necessary before testing the intervention in Phase 2, which will involve a randomized factorial trial.
Detailed description
Mental health problems during early adolescence are a global concern, especially in low- and middle-income countries (LMICs). North Macedonia and the Republic of Moldova are among the poorest countries in Europe and many children in these countries are exposed to risk factors for negative mental health outcomes, such as family violence. In addition, the recent coronavirus pandemic and war in Ukraine have greatly increased economic, social, and psychological challenges in Eastern Europe. This situation makes the prevention of mental health problems and promotion of well-being among adolescents in North Macedonia and Republic of Moldova a high priority.
Parenting programs are recommended by many health guidelines as evidence-based solutions to support adolescent well-being. One example of a program developed specifically for low- and middle-income contexts is Parenting for Lifelong Health (PLH), a group-based social-behavioral intervention. However, a major challenge of implementing such programs entails sustaining and embedding them into lasting delivery systems (scaling-up). As a result, it is critical to optimize parenting programs in low-resource settings. Specifically, it is essential to identify the most effective and cost-effective components of parenting programs.
The present project, "FLOURISH", aims to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) and the Helping Adolescents Thrive (HAT) Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of the adapted version. The program will be delivered by ALTERNATIVA in North Macedonia and Health for Youth Association in the Republic of Moldova.
FLOURISH will consist of one clinical study with three phases (studies will be registered separately) based on the MOST framework:
Phase 1: Program adaptation and piloting (Preparation of MOST)
Phase 2: Factorial trial and process evaluation (Optimization of MOST)
Phase 3: Hybrid implementation-effectiveness randomized trial and process evaluation (Evaluation of MOST).
This protocol is for the Preparation phase of MOST and will inform the subsequent phases of the project. It consists of a pre-post evaluation testing the feasibility of the program with 30 caregivers and their children aged 10-14 years old in each country site and examining outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness in improving teens' mental health and family well-being.
The PLH for Parents and Teens program will include an adolescent peer support component and adolescent participation boosters, which are candidate components for testing in Phase 2. The peer support component will introduce a systematic strategy of social support enhancement in each intervention group. Each adolescent will pair up with another adolescent from their group.The adolescent participation boosters will involve a selection of incentives for participation that will be determined based on initial coproduction activities.
As an add-on to the PLH program and third candidate component to pilot in Phase 1, the Magnificent Mei comics as part of the Helping Adolescents Thrive materials will be provided to adolescents for at home practice. The comics consists of 6 chapters which cover the following topics: adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other. We will adapt the content together with UNICEF and the advisory groups.
In addition, all study materials will be adapted into the local languages (Romanian, Macedonian, and Russian). The assessment measures will be translated following a detailed translation script. This also includes intervention cost and other health economic measures for resource use (PECUNIA RUM), health-related quality of life (EQ5D-5L, EQ5D-Y(3L)) and capability well-being (OxCAP-MH) used to evaluate costs and outcomes for the cost effectiveness analyses in Phase 2. The initial psychometric results from a mini pilot (5 adolescents and 5 caregivers for each language), as well as the pre-post outcomes during this phase, will inform decisions on measures for Phase 2.
This study will also pilot a range of measures, reported by implementation staff, to record the time and resources required for intervention delivery, document the background and well-being of frontline intervention staff, and assess the fidelity of intervention delivery, using a structured observation tool.
The pilot feasibility study will be informed by other activities during this Phase. This include coproduction advisory groups with caregivers, adolescents, intervention staff, and professional experts, context-mapping expert interviews, and post-intervention focus-groups. These activities will be informative in assessing feasibility and acceptability of the intervention and context specific adaptations.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be allocated to the same intervention arm for this pilot feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Parenting for Lifelong Health | Experimental | Behavioral: Parenting for Lifelong Health for Parents and TeensParenting Program "Parenting for Lifelong Health" (PLH) for parents and their teens aged 10-14 years old with Helping Adolescents Thrive comics at home |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- for Caregivers:
- for Adolescents:
Key exclusion criteria (1 listed)
- No formal exclusion criteria have been set for FLOURISH. However, during the process of introducing the project, the research team will guide the participants through a consent form that asks whether they are currently experiencing acute distress or a mental health or physical health condition that would interfere with their participation. The judgement will be made by the potential participant. If the participant decides they are not currently able to take part due to acute health issues, the research team will follow up and provide referrals for 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 TeensPLH will be delivered over 6 sessions as a group-based family program with both adolescents and caregivers attending, with joint and separate core sessions framed by joint introductions and endings. It will include activities such as: building positive parent-child relationships; developing problem-solving skills; stress-management and stress-reduction skills; improving effective limit-setting and discipline by parents; talking about feelings and regulating emotions. The PLH program will also include a peer support component and incentive boosters. The Helping Adolescents Thrive comic chapters will be provided as homework activities. The comics, developed by UNICEF, cover adaptation to new situations, stress management, problem-solving, communication skills, risky choices and being there for each other. | Behavioural | Parenting for Lifelong Health |
Primary outcome
Change in levels of adolescent emotional problems: Revised Child Anxiety and Depression Scales (RCADS), subscales
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The RCADS is a self-report measure developed to evaluate among children symptoms of a number of DSM defined anxiety and depression disorders with two 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''.
Change in levels of adolescent emotional problems: 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 adolescent emotional problems: Youth Self-Report (YSR) 11-18, internalizing subscale
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The YSR 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 adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscales rule-breaking and aggressive behavior
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). 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.
Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscales rule-breaking and aggressive behavior
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
The YSR is an instrument from the Achenbach System of Empirically Based Assessment (ASEBA). These YSR is widely used 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.
Change in levels of well-being in adolescents: World Health Organization-Five Well-Being Index (WHO-5), total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
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) with a range of scores from 0 (absence of well-being) to 25 (maximum score on well-being).
12 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 levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in frequency of parenting practices: Alabama Parenting Questionnaire-APQ, subscale "involved parenting", subscale "parental supervision/monitoring " (parent- and child-report) and subscale "corporal punishment" (parent-report)
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of social support in adolescents and 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 well-being in caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of adolescent behavior problems: Child Behavior Checklist (CBCL) 6-18, parent-report, subscale externalizing behavior
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of adolescent behavior problems: Youth Self-Report (YSR) 11-18, child-report, subscale externalizing behavior
Time frame: Pre-assessment and 6 - 8 weeks after pre-assessment
Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score
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 16 May 2024.
- Individual participant dataSharing planned: Yes. The project has a detailed data management plan (DMP) that defines data sharing procedures. The DMP is provided as a deliverable to the European Commission and 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 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
2 sites in 2 countries: 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 in people with Adolescent Behavior and Adolescent - Emotional Problem, 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 10 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 16 May 2024. 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?
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 adolescent emotional problems: Revised Child Anxiety and Depression Scales (RCADS), subscales (time frame: Pre-assessment and 6 - 8 weeks after pre-assessment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.