Condition category
Mental and Behavioural Disorders
Date applied
11/06/2018
Date assigned
05/07/2018
Last edited
05/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Low-income families often have additional challenges in their parenting related to poverty, domestic violence, child abuse or substance abuse. Adults tend to experience high levels of parental stress and depressed mood. These factors have been linked with behavioral and emotional problems in children or teenagers, academic problems, negligence and child abuse, substance abuse or risky behavior. Parenting challenges generally include parents using force on children, negative family interactions, inappropriate communication patterns, and strictness. Positive Parenting Programs (Triple P) aim to encourage consistent and responsive family environments in which the child feels accepted and nurtured. This type of intervention has been identified as the most effective in reducing levels of child abuse and promoting society well-being. Portugal lacks positive parenting programs that might be used by field professionals who intend to implement such practices. To date, no studies with the Triple P system are known in Portugal. The current study evaluates the efficacy of the Group Triple P (level 4) with psychosocial risk Portuguese mothers.

Who can participate?
Mothers or maternal substitutes of children aged between 3 -12 years living in psychosocial risk

What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group will be pre-contacted by telephone about 1 week before Group Triple P (intervention) start. The control group will continue to be contacted for usual intervention. All participants will receive a letter with call for evaluation interview 2 weeks after the end of Group Triple P and in 12-month follow-up.

What are the possible benefits and risks of participating?
There are no risks for the participants; and previous studies show reduced anxiety, stress and depression, and parental stress in mothers, an increase in parental self-efficacy, the adoption of more appropriate parenting practices (e.g., increased parental involvement and use of positive discipline, less physical punishment and verbal hostility), and an increase in the informal network of social support are also expected.

Where is the study run from?
Department of Social Income in Santa Casa da Misericórdia de Penafiel, Porto – Portugal.

When is the study starting and how long is it expected to run for?
January 2016 to June 2019.

Who is funding the study?
There is no external funding for this study.

Who is the main contact?
Sandra Nogueira
sandracat27@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Orlanda Cruz

ORCID ID

Contact details

R. Alfredo Allen
Porto
Porto
4200-135
Portugal

Type

Scientific

Additional contact

Prof Isabel Macedo - Pinto

ORCID ID

Contact details

R. Alfredo Allen
Porto
4200-135
Portugal

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2-12/2016

Study information

Scientific title

Group Triple P: a randomized control trial in a group of psychosocial risk Portuguese mothers

Acronym

Study hypothesis

Triple P is expected to demonstrate its efficacy by significantly reducing emotional and behavioral symptoms in children, and by decreasing levels of anxiety, stress and depression, and parental stress in mothers. An increase in parental self-efficacy, the adoption of more appropriate parenting practices (e.g., increased parental involvement and use of positive discipline, less physical punishment and verbal hostility), and an increase in the informal network of social support are also expected.

Ethics approval

Ethics board of the Faculty of Psychology and Educational Sciences of the University of Porto, in the person of its president Professor Dr. Marianne Lacomblez, 12/12/2016, 2-12/2016

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Mental health in caregivers and their children who live in high psychosocial risk situations

Intervention

Participants were identified by social services and will be randomly allocated in two groups, intervention and treatment as usual control group. Participants randomization was made according to a list of computer generated numbers. The research assistants involved in the evaluation will be blind to the process of randomization.
Group Triple P is a group variant of Level 4 Triple P providing moderate to high intensity intervention and focusing on improving parent-child interaction and the application of parenting skills to a broad range of target behaviors. It consists of four weekly group sessions, three individual phone consultations and one closure group session. Given the low level of literacy of participating mothers, the first and third sessions were divided in two (as described in the Triple P manual) so as to attain all established objectives. Each group session lasts for approximately 2 hours, while the phone consultations are supposed to take 15-20 minutes each. The group sessions include content presentation, video watching, group discussions, and role-play exercises to promote positive and consistent parenting practices. Parents are also encouraged to do take-home exercises to reinforce the content provided in each session. Group Triple P utilizes an active skills training process to teach parents a variety of parenting skills. Parents are introduced to 17 positive parenting strategies including strategies to develop good relationships with children, encourage desirable behaviors, teach new skills and behaviors, and manage children’s misbehavior, as well as planned activities routines for high-risk situations to help parents to generalize and maintain parenting skills across settings and over time. During phone sessions, difficulties identified by parents or issues that parents would like to debate are discussed with practitioner.
Parents in the control group will receive treatment-as-usual. Mothers receive economic support from Portuguese social welfare and have an individual or familiar intervention assured by caseworker. Once the intervention and evaluation protocols are completed, mothers in control group who wish to participate will be given the opportunity to attend the program.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Emotional and behavioral symptoms in children, measured through the subscales of the Strengths and Difficulties Questionnaire (SDQ-P; Godman, 1997) and Conner’s Teacher Rating Scale (Conners, 1998). This measures will be accomplished by principal caregivers and teachers at three timepoints: pre-intervention, post-intervention and at 12-months follow-up.
2. Parental sense of competence, measured through the subscales of the Parental Sense of Competence Scale (PSOC; Gibaud-Wallston & Wandersman, 1978)
3. Parent's use of ineffective parenting practices, measured through the subscales of Parenting Scale (Arnold, O´Leary, Wolff & Acker, 1993) and the Alabama Parenting Questionnaire (Frick, 1991).
These are self-report measures and will be filled by caregivers at three timepoints: pre-intervention, post-intervention and at 12-months follow-up.

Secondary outcome measures

1. Parental psychological adjustment, measured by the subscales of Depression-Anxiety-Stress (DASS-21, Lovibond & Lovibond, 1995)
2. Parental stress, measured by subscales of Parental Stress Index-Short Form (PSI-SF, Abidin, 1990)
3. Informal social support network, measured through an adapted version subscale of Medical Outcomes Study Social Support Survey (MOS-SSS, Sherbourne & Stewart, 1991).
These are self-report measures and will be filled by principal caregivers at three timepoints: pre-intervention, post-intervention and at 12-months follow-up.

Overall trial start date

02/01/2016

Overall trial end date

30/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Portuguese mothers or maternal substitutes
2. Principal caregiver of child aged 3 to 12 years
3. At psychosocial risk due to low income
4. Receiving economic support from Portuguese social welfare

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

120 participants

Participant exclusion criteria

1. Has a child or children with developmental disorders (e.g. autism) and/or chronic illness
2. Has an intellectual impairment or is hearing/visually impaired
3. Current drug/alcohol abuse

Recruitment start date

01/04/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

Portugal

Trial participating centre

Santa Casa da Misericórdia de Penafiel
GAB. RSI Largo de Santo António dos Capuchos
Penafiel
4560-454
Portugal

Sponsor information

Organisation

Faculty of Psychology and Educational Sciences of the University of Porto

Sponsor details

R. Alfredo Allen
Porto
Porto
4200-135
Portugal

Sponsor type

University/education

Website

www.fpce.up.pt

Funders

Funder type

Not defined

Funder name

Investigator Initiated and Funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/06/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes