Protecting youth from interpersonal violence via implementation of the Strengthening Families Programme 10-14 in Panama

• Register: ISRCTN
• Last refreshed on: 5 February 2024
• Main ID: ISRCTN14023111
• Date of registration: 13/07/2017
• Prospective Registration: No
• Primary sponsor: The University of Manchester
• Public title: Protecting youth from interpersonal violence via implementation of the Strengthening Families Programme 10-14 in Panama
• Scientific title: PRO YOUTH trial: protecting youth from interpersonal violence via implementation of the Strengthening Families Programme 10-14 in Panama: a cluster randomized controlled trial
• Date of first enrolment: 01/07/2017
• Target sample size: 841
• Recruitment status: Stopped
• URL: https://www.isrctn.com/ISRCTN14023111
• Study type: Interventional
• Study design: Cluster randomized controlled trial (Prevention)
• Phase: Not Applicable

Countries of recruitment

Panama

Contacts

• Name: Rachel Calam

Key inclusion & exclusion criteria

Inclusion criteria: Current inclusion criteria as of 05/06/2018:
1. Families with a male or female adolescent between 10 and 14 years old
2. At least one primary caregiver and one child 10-14 are willing to attend the programme together within a fixed time period if a place is offered
3. The ability to speak Spanish (literacy aid will be provided to parents or children who cannot read or write)
4. Families can be recruited from those who access services from the centres or widely from the community

Previous inclusion criteria:
1. Families with a male or female adolescent between 10 and 14 years old
2. At least one primary caregiver and one child 10-14 are willing to attend the programme together within a fixed time period if a place is offered
3. The ability to speak Spanish (literacy aid will be provided to parents or children who cannot read or write)
Exclusion criteria: 1. Families in which children and parents live separately (e.g., the child is in care)
2. Families that have participated in SFP 10-14 (Familias Fuertes) previously
3. Families that have taken part in any other family-based intervention in the last 12 months

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Interpersonal violence in adolescents 10-14 years old
Mental and Behavioural Disorders

Intervention(s)

There are 28 clusters (i.e., schools or clinics) and 30 families are recruited per cluster. Clusters (i.e., clinics or schools) will be randomized to:
1. Implementation of Familias Fuertes in health and educational services (clinics and schools)
2. Services-as-usual (control)
A minimization algorithm will be used to ensure equivalency across arms in terms of: (i) the population size of townships where the clinic/school is located, (ii) homicide rates per 10,000 inhabitants in townships, and (iii) type of site (e.g. clinic or school). Sites will be allocated using online software (www.sealedenvelope.com). Given that this is a real-world implementation trial that involves training a limited number of staff embedded in selected clusters, these need to be randomized before families are recruited into the study. The trialists are aware that randomization of clusters before recruiting participants can influence recruitment and dropout in the control arm. To minimize these issues, the trialists have included costs for compensating families for participation and will instruct staff not to reveal site allocation until families have agreed to take part and before signing informed consent.

SFP 10-14 (Familias Fuertes) will be delivered in groups of approximately 10 families (a minimum of 6 and a maximum of 16 families). The programme comprises 7 weekly sessions of two hours each. Parent and adolescent sessions are conducted separately in the first hour, followed by a second hour together as a family. The first hour focuses on skills, with the second hour designed to recognise family strengths and practice skills covered in the first hour. The intervention addresses three broad areas: family functioning, including communication between parents and children; strengthening pa

Primary Outcome(s)

Current primary outcome measures as of 05/06/2018:
Problem behaviours, measured with the Externalizing subscale of the Child Behaviour Checklist (Parent Version) for children 6 to 18 years that measures rule-breaking and aggressive behaviour. This scale consists of 35 items responded by parents using a scale from 0 to 2, being 0 = not true, 1 = somewhat or sometimes true, and 2 = very true or often true. The questionnaire takes 10 minutes to complete. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
All outcomes will be assessed via face-to-face sessions in schools or clinics, via telephone interviews or through delivery/pick up of questionnaires to family homes. Format of assessment will depend on family’s individual preferences.

Previous primary outcome measures:
Problem behaviours, measured with the Externalizing subscale of the Child Behaviour Checklist (Parent Version) for children 6 to 18 years that measures rule-breaking and aggressive behaviour. This scale consists of 35 items responded by parents using a scale from 0 to 2, being 0 = not true, 1 = somewhat or sometimes true, and 2 = very true or often true. The questionnaire takes 10 minutes to complete. Measured at baseline, 2, 6 and 12 months follow-up

Secondary Outcome(s)

Current secondary outcome measures as of 05/06/2018:
Parent reported:
1. Family functioning, measured with the Family Relationship Index (FRI). The FRI is a 27-item uni-dimensional measurement of the quality of social relationships in the family environment as determined by cohesion, expressiveness and conflict. Participants respond True or False to each item. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
2. Parental discipline, measured with the Parenting Scale (PS). The PS is a 7-point Likert-scale 30-item questionnaire that measures parenting practices in three subscales: laxness, over-reactivity and hostile parenting. Laxness refers to a parent’s inconsistency or permissive parenting, while over-reactivity refers to a parent’s harsh or punitive parenting. Hostile parenting refers to the extent to which a parent hits, curses or insults their child. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
3. Parental stress, measured with the Depression-Anxiety-Stress Scale 21 (DASS-21). DASS-21 is a 21 self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. The individual is required to indicate the presence of a symptom over the previous week. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week). Measured at baseline (T0), 2 (T1) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
4. Quality of life, measured with the ED-5D-5L, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. The validated Spanish version provided by EuroQoL is used. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.

Adolescent reported
1. Problem behaviours, measured with the Externalizing Subscale of the Youth Self-Report CBCL (YSR). It is composed of 32 items that are responded on a 0 to 2 scale, being 0 = not true, 1 = somewhat or sometimes true, and 2 = very true or often true. As in the parent-reported version of the CBCL, the YSR assesses rule-breaking and aggressive behaviour. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
2. Family functioning, measured with the Family Relationship Index. Measured at baseline, 2, 6 and 12 months follow-up
3. Parental discipline, measured with the Children’s Report of Parent Behaviour Inventory. This instrument has 52 items to evaluate the relationship of the child with his/her mother and 52 items to evaluate relationship with his/her father. Items are responded in a 1-3 scale, being 1 = never, 2 = sometimes and 3 = often. Measured at baseline (T0), 2 (T1) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
4. Quality of life, measured with the Child Health Utility 9 Dimensions, which is a paediatric generic preference based measure of health related quality of life. It allows the calculation of quality adjusted life years (QALYs) for use in cost utility analysis. It assesses 9 dimensions with 5 response options each. The validated Spanish version provided by Scharr at the University of Sheffield will be used. Measured at baseline (T0), 2 (T1), 6 (T2) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
5. Substance misuse, measured with 10 items from the Health Behaviour for School-Aged Children Questionnaire (HBSC). These items measure frequency of smoking cigarettes and e-cigarettes, frequency of use of different types of alcoholic drinks, age of initiation of alcohol use and smoking, marijuana intake and use of other drugs. Measured at baseline (T0), 2 (T1) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
6. Gang involvement, measured with the Jamaica Survey of Gang Involvement from the Jamaica Youth Survey. While the full survey is 107 items to measure five core competencies, for this study only 4 items that measure previous gang history are used. Measured at baseline (T0) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.
7. Delinquency, measured with the Self-Report Delinquency Scale. This instrument has 39 items in which adolescents respond how many times in the last 6 months have they engaged in delinquent and criminal activities. They are able to choose from (a) once a month, (b) once every 2-3 weeks, (c) once a week, (d) 2-3 times a week, (e) once a day, to (f) 2-3 times a day. Measured at baseline (T0) and 12 months follow-up (T3). The primary endpoint is at 12 months follow-up or T3.

Previous secondary outcome measures:
Parent reported:
1. Family functioning, measured with the Family Relationship Index (FRI). The FRI is a 27-item uni-dimensional measurement of the quality of social relationships in the family environment as determined by cohesion, expressiveness and conflict. Participants respond True or False to each item. Measured at baseline, 2, 6 and 12 months follow-up
2. Parental discipline, measured with the Parenting Scale (PS). The PS is a 7-point Likert-scale 30-item questionnaire that measures parenting practices in three subscales: laxness, over-reactivity and hostile parenting. Laxness refers to a parent’s inconsistency or permissive parenting, while over-reactivity refers to a parent’s harsh or punitive parenting. Hostile parenting refers to the extent to which a parent hits, curses or insults their child. Measured at baseline, 2, 6 and 12 months follow-up
3. Parental stress, measured with the Depression-Anxiety-Stress Scale 21 (DASS-21). DASS-21 is a 21 self-report questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. The individual is required to indicate the presence of a symptom over the previous week. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week). Measured at baseline, 2 and 12 months follow-up
4. Quality of life, measured with the ED-5D-5L, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. The validated Spanish version provided by EuroQoL is used. Measured at baseline, 2, 6 and 12 months follow-up

Adolescent reported
1. Problem behaviours, measured with the Externalizing Subscale of the Youth Self-Report CBCL (YSR). It is composed of 32 items that are responded on a 0 to 2 scale, being 0 = not true, 1 = somewhat or sometimes true, and 2 = very true or often true. As in the parent-reported version of the CBCL, the YSR assesses rule-breaking and aggressive behaviour. Measured at baseline, 2, 6 and 12 months follow-up
2. Family functioning, measured with the Family Relationship Index. Measured at baseline, 2, 6 and 12 months follow-up
3. Parental discipline, measured with the Children’s Report of Parent Behaviour Inventory. This instrument has 52 items to evaluate the relationship of the child with his/her mother and 52 items to evaluate relationship with his/her father. Items are responded in a 1-3 scale, being 1 = never, 2 = sometimes an

Secondary ID(s)

R120374

Source(s) of Monetary Support

Medical Research Council

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. University of Manchester Research Ethics Committee 1 (UK), 16/05/2017, ref: 2017-0717-2872 2. Research Ethics Committee from Punta Pacifica Hospital (Panama), 23/03/2017, ref: 28

Results

• Results available: Yes
• Date Completed: 01/03/2020