Family-Focused Adolescent & Lifelong Health Promotion Phase 2
NCT Number: NCT06562244
Acronym: FLOURISH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Adolescent - Emotional Problem|Parent-Child Relations|Family Functioning|Well-Being, Psychological
Interventions: BEHAVIORAL: Parenting for Lifelong Health for Parents and Teens (PLH)|BEHAVIORAL: Helping Adolescents Thrive comics|BEHAVIORAL: I Support My Friends
Sponsor: University of Klagenfurt
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
Sex: ALL
Age: CHILD
Enrollment: 640
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09
Completion Date: 2025-06

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. 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.

Primary Outcome Measures: 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., 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., 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., 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), During the implementation of the intervention (6 - 8 weeks)
Secondary Outcome Measures: 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)., 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)., 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., 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., 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)., 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)., 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., 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''., 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., 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., 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., 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)., 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., 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"., 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., 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., 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., 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., 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., Pre-assessment and 6 - 8 weeks after pre-assessment
Other Outcome Measures: Adolescent healthy weight: BMI; adolescent and caregiver reports, Adolescent healthy weight will be assessed with caregiver and adolescents report on the adolescent's mass in kilograms and height in meters. This is not expected to change as a result of the intervention, but is assessed for sample description., Pre-assessment and 6 - 8 weeks after pre-assessment|Caregiver alcohol use: The Alcohol Use Disorder Identification Test (AUDIT), total score, The AUDIT contains 10 questions concerning alcohol consumption, drinking behaviors, and alcohol-related problems. It is scored from 0 to 4 for each question, resulting in a total score ranging from 0 to 40., Pre-assessment and 6 - 8 weeks after pre-assessment|Post-traumatic stress in caregivers: PTSD checklist for DSM-5 (PCL-5), short form, total score, The 4-item version of the PCL-5 is a short form of the original PCL-5 consisting of 20 items. These are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), with higher scores indicating greater symptom severity. This tool is particularly useful for screening purposes and includes Criterion A, which refers to exposure to actual or threatened death, serious injury, or sexual violence, as a critical aspect of assessing PTSD symptoms. The tool will be completed by caregivers., Pre-assessment and 6 - 8 weeks after pre-assessment|Posttraumatic stress in adolescents: Children's Revised Impact of Event Scale (CRIES), total score, "intrusion and avoidance subscales", The CRIES is organized into two dimensions-intrusion (4 items) and avoidance (4 items) and a total score. The items are scored on a four-point scale: "not at all" receives 0 scores, "rarely" sums 1 point, "sometimes" adds 3 points, and "often" computes 5 points. This tool will be completed by adolescents., Pre-assessment and 6 - 8 weeks after pre-assessment|Well-being among intervention staff: 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)., Pre-assessment and 6 - 8 weeks after pre-assessment|Parental stress among intervention staff: 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., Pre-assessment and 6 - 8 weeks after pre-assessment|Fidelity of intervention delivery: PLH-Facilitator Assessment Tool (PLH-FAT), The assessment tool focuses on various aspects of facilitator performance, and includes the percentage score on the completion of intervention activities and the percentage score on the demonstration of intervention skills., During the implementation of the intervention (6 - 8 weeks)|Attendance rate - Other Subscales, Percentage of group PLH sessions attended by both adolescent and caregiver in a given family (family attendance); Percentage of catch-up PLH contact out of 6 (family); Percentage of adolescents attending Magnificent Mei (1 session) and I Support My Friends (2 sessions)., During the implementation of the intervention (6 - 8 weeks)|Enrollment rate, Percentage of participants who joined the study and have attended at least one group PLH session (individual enrollment for adolescents and caregivers) and percentage of families where both adolescent and caregiver attended at least one group PLH session (family enrollment)., During the implementation of the intervention (Six weeks)|Intervention costs, Personnel time resources associated with the training and delivery of the intervention, organizational, material, transportation and consumable costs., During the implementation of the intervention (6 - 8 weeks)|Adolescent defined problems: The Top Problem Assessment, The Top Problem Assessment assesses adolescents' problems they are most concerned about. They can name three problems they choose and provide numerical severity ratings on a scale ranging from 0 to 4., Pre-assessment and 6 - 8 weeks after pre-assessment