Clinical trial NCT06562244: Family-Focused Adolescent &Amp; Lifelong Health Promotion Optimization Trial
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Klagenfurt
Sponsor class: OTHER
Collaborators: name: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Cardiff University
name: Association for Systematic Therapy Education Center
name: Medical University of Vienna
name: University Jaume I Castellon
name: Bielefeld University
name: Health for Youth Association, Moldova
First posted: 2024-08-20
Enrollment: 640
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in levels of caregiver-reported emotional problems in adolescents: Child Behavior Checklist (CBCL) 6-18, "internalizing subscale"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: 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"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Attendance rate
timeFrame: During the implementation of the intervention (6 - 8 weeks)
Secondary outcomes:
measure: Change in levels of family communication in adolescents: Child-Parent Communication Apprehension scale (CPA-YA), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: 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)
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of social support in adolescents: Medical Outcome Study Social Support Survey (MOS-SSS), "affectionate subscale"
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of well-being in adolescents and caregivers: World Health Organization-Five Well-Being Index (WHO-5), total score
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of psychological distress in caregivers: Patient Health Questionnaire - 9 (PHQ-9), total score
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of parental stress in caregivers: Parental Stress Scale (PSS), total score
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of emotional problems in adolescents: Revised Child Anxiety and Depression Scales (RCADS), total score, "depression and anxiety subscales"
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: Change in levels of loneliness in caregivers: Revised UCLA Loneliness scale (RULS-6), total score
timeFrame: Pre-Post (approximately 6 - 8 weeks after pre-assessment)
measure: 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"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of social support in caregivers: Medical Outcome Study Social Support Survey (MOS-SSS), "emotional and affectionate subscales"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of family functioning in caregivers: Family Assessment Device (FAD), "problem solving and communication subscales"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in levels of emotional problems in adolescents: Pediatric Symptom Checklist (PSC), adolescent and caregiver report, total score, "internalizing, externalizing and attention subscales"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: 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"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in adolescent health-related quality of life: EQ-5D-Y-3L
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in caregiver health-related quality of life: EQ-5D-5L
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in caregiver capabilities: Oxford CAPabilities questionnaire - Mental Health (OxCAP-MH)
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in caregiver resource use: PECUNIA Resource Use Measurement (PECUNIA RUM)
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Change in caregiver-reported resource use in adolescents: PECUNIA Resource Use Measurement (PECUNIA RUM) proxy for adolescents
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
Other outcomes:
measure: Adolescent healthy weight: BMI; adolescent and caregiver reports
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Caregiver alcohol use: The Alcohol Use Disorder Identification Test (AUDIT), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Post-traumatic stress in caregivers: PTSD checklist for DSM-5 (PCL-5), short form, total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Posttraumatic stress in adolescents: Children's Revised Impact of Event Scale (CRIES), total score, "intrusion and avoidance subscales"
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Well-being among intervention staff: World Health Organization-Five Well-Being Index (WHO-5), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Parental stress among intervention staff: Parental Stress Scale (PSS), total score
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
measure: Fidelity of intervention delivery: PLH-Facilitator Assessment Tool (PLH-FAT)
timeFrame: During the implementation of the intervention (6 - 8 weeks)
measure: Attendance rate - Other Subscales
timeFrame: During the implementation of the intervention (6 - 8 weeks)
measure: Enrollment rate
timeFrame: During the implementation of the intervention (Six weeks)
measure: Intervention costs
timeFrame: During the implementation of the intervention (6 - 8 weeks)
measure: Adolescent defined problems: The Top Problem Assessment
timeFrame: Pre-assessment and 6 - 8 weeks after pre-assessment
Locations:
city: Skopje
country: North Macedonia
facility: Institute Alternativa
Study officials:
affiliation: University of Klagenfurt
name: Heather M Foran, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Yulia Shenderovich, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Marija Raleva, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Health for Youth Association, Moldova
name: Galina Lesco, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Graham Moore, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiff University
name: Rhiannon Evans, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Vienna
name: Judit Simon, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Bielefeld University
name: Nina Heinrichs, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Association of Systemic Therapists Education Centre
name: Nevena Calovska, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University Jaume I Castellon, Spain
name: Bojan Shimbov, Prof
role: PRINCIPAL_INVESTIGATOR
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