Family-Focused Adolescent & Lifelong Health Promotion

NCT05930535 | Completed DMC

• 1 other identifier: 101095528
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Adolescent Behavior; Adolescent - Emotional Problem; Psychological Well-Being; Parent-Child Relations; Parenting

Keywords

Parenting; Mental health; MOST design; Adolescents; Family-based intervention

Outcome Measures

Primary Outcomes (6)

• 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''.

  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.

  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.

  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.

  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.

  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).

  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

  Pre-assessment and 6 - 8 weeks after pre-assessment

• Change in levels of family functioning in caregivers: Family Assessment Device (FAD), subscale "general functioning"

  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)

  Pre-assessment and 6 - 8 weeks after pre-assessment

• Change in levels of loneliness in adolescents: UCLA-8 Loneliness scale, total score

  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"

  Pre-assessment and 6 - 8 weeks after pre-assessment

Other Outcomes (8)

• Enrollment rate

  During the implementation of the intervention (Six weeks)

• Attendance rate

  During the implementation of the intervention (Six weeks)

• Adolescent healthy weight: BMI; adolescent and caregiver reports

  Pre-assessment and 6 - 8 weeks after pre-assessment

Study Arms (1)

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

Behavioral: Parenting for Lifelong Health for Parents and Teens

Interventions

Parenting for Lifelong Health for Parents and Teens BEHAVIORAL

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.

Parenting for Lifelong Health

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• for Adolescents:
• Age 10-14 at baseline assessment;
• Assent to participate in the study;
• Caregiver consent to participate in the study.

Sponsors & Collaborators

• University of Klagenfurt: lead
• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA: collaborator
• Health for Youth Association, Moldova: collaborator
• Cardiff University: collaborator
• Bielefeld University: collaborator
• Association for Systematic Therapy Education Center: collaborator
• Medical University of Vienna: collaborator
• University Jaume I Castellon: collaborator

Study Sites (2)

Health For Youth Association

Chisinau, Moldova

Location

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, North Macedonia

Location

MeSH Terms

Conditions

Adolescent Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Heather Foran, Prof.

  University of Klagenfurt

  PRINCIPAL INVESTIGATOR

• Yulia Shenderovich, Dr.

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Marija Raleva, Prof.

  Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  PRINCIPAL INVESTIGATOR

• Galina Lesco, Prof.

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Graham Moore, Prof.

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Rhiannon Evans, Prof.

  Cardiff University

  PRINCIPAL INVESTIGATOR

• Nina Heinrichs, Prof.

  Bielefeld University

  PRINCIPAL INVESTIGATOR

• Judit Simon, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

• Nevena Calovska, Prof.

  Association of Systemic Therapists Education Centre

  PRINCIPAL INVESTIGATOR

• Bojan Shimbov, Prof.

  University Jaume I Castellon, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be allocated to the same intervention arm for this pilot feasibility study.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 5, 2023
• Study Start: September 18, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 27, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of the study and publication of main results.
• Access Criteria: Prof. Heather Foran is responsible for data management of the FLOURISH project. For information related to data sharing, please contact her at heather.foran@aau.at

Locations

NO (1); MO (1)