Plain English Summary
Background and study aims
Parents and family are essential for a childs development and well-being. Since the trajectory of an individuals mental health begins in childhood, it is of importance to reach parents in efforts to promote childrens positive development. The program in this trial, the ABC program, is a structured health-promoting universal parent program that targets parents of children aged 3-12 years. The program aims for increasing parental competence as well as childrens development and well-being by strengthening the relationship between parents and their children. The overall aim of this trial is to evaluate the effects and the implementation of the ABC program.
Who can participate?
Parents were informed of the opportunity to participate in an ABC parent group within the study by information given in child health centres, family centres, Social Services Offices, in parent meetings at schools, primary schools and preschools, but also by adverts in local newspapers, magazines targeted towards parents, and adverts on different web sites.
What does the study involve?
Families are randomly assigned to either the intervention group or to a 6-month waiting list control group. The intervention group participates in the ABC program while the 6-month waiting list control group will not receive any parental intervention or other family treatment during the waiting list period, but will receive the program after 6 months. The ABC program comprises four parent group sessions, which are held every other week during an 8-week period, with an optional booster session after the 6-month follow-up. At the sessions the parents discuss how to obtain or develop certain parental skills, which they are supposed to practice at home with their child. Parents get information and support in how to enhance parental competence and positive child development. The method consists of four sessions with the themes showing love, being together, guiding and pick your battles. Sessions are led by two trained group leaders with various backgrounds such as pre-school teachers, teachers, counsellors and psychologists. Participants complete questionnaires before the intervention, immediately after the intervention as well as six and twelve months after the start of the intervention. Parents rate their own mental health and parenting practices, as well as the childs mental and physical health and relationships with their parents and peers. The control group also answers the questionnaires at the same time, except for the 12-month follow-up.
What are the possible benefits and risks of participating?
The benefits of participation in this study are that parents participate in a program that is implemented in schools and pre-schools ordinary work. The risk of participation in this study is that the program turns out to be not effective in the described outcomes.
Where is the study run from?
The County of Stockholm, Sweden.
When is the study starting and how long is it expected to run for?
The study will run from February 2012 to June 2014.
Who is funding the study?
Swedish National Institute of Public Health (Sweden).
Who is the main contact?
Lene Lindberg
lene.lindberg@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lene Lindberg
ORCID ID
Contact details
Karolinska Institutet
Box 17070
Stockholm
SE 104 62
Sweden
lene.lindberg@ki.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Universal parental support program for increasing parental efficacy, childrens mental health and well-being a randomized controlled trial
Acronym
ABC-RCT
Study hypothesis
1. Parents own experiences of parental efficacy will increase at follow-up in the intervention group, compared to the control group
2. The parents in the intervention group will report higher levels of mental health and well-being for their children at post intervention period, and at six-month follow-up, compared to parents in the control group
3. The expected effects are moderated by parents country of birth, socio-economic status such as income and level of education, levels of program fidelity of group leaders, and parents commitment to the ABC-method and to the group meetings
4. The expected effects are mediated by parents retaining of family rules, positive and negative reinforcement, parents mental health and emotion regulation
5. Intervention will improve the parenting, which is moderated by strengthening the parents relationship and well-being. These improvements affect their childrens positive development
6. A health economic evaluation of the ABC-program will demonstrate savings and health gains
Ethics approval
Regional Review Board at the Karolinska Institutet, 16/02/2012, ref: 2012/93-31/5
Study design
Clustered multi centre randomization design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet [Swedish]
Condition
Development of child mental and physical health
Intervention
Intervention group receives parental support consisting of the ABC-method, where the program format comprises four parent group sessions which are held every other week during an eight week period, with an optional booster session after two-three months. At the sessions the parents discuss and reflect on certain parental skills which they are encouraged to practice at home with the child. Parents get information and support in how to strengthen already existing promotive factors within the family in order to enhance the positive child development. The program format consists of four sessions with the themes; showing love; being together; guiding and pick your battles. Sessions are led by two trained group leaders with various backgrounds such as pre-school teachers, teachers, social workers and psychologists. The leader education consists of four and a half days of lectures and training under supervision.The 6-month wait-list control group will not receive any parental intervention or other family treatment during the waiting list period.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time points of primary interest for all outcome measures are at baseline, two weeks after intervention period and six months after intervention start.
Parental Self-Efficacy (PSE) to measure parents perception of their parenting on a 48-item questionnaire rated on 11-point Likert scale, ranging from 0=completely disagree to 10= completely agree. The questionnaire is composed of 8 subscales adapted from a Tool to Measure Parenting Self-efficacy TOPSE (unpublished data). The questionnaire covers the dimensions of positive emotion, play, empathy, guiding, rules, pressures, acceptance and experience.
Ratings of childrens wellbeing are measured by the parent report of KIDSCREEN-52: a questionnaire with 52 items rated on a 5-point Likert scale to measure childs mental and physical well-being, moods, relations with parents and peers, and social functioning. Assesses frequency of behaviour/feelings (never-seldom-sometimes-often-always) and intensity of attitudes (not at all-slightly-moderately-very-extremely).
Secondary outcome measures
Current secondary outcome measures as of 08/04/2013:
Program fidelity by group leaders is measured by observations of recorded program sessions. The group leaders are rated according to two dimensions. One regarding competence in terms of framework, speaking with own terms, well prepared, presenting the program in a positive manner, activating parents, strengthening parents and interaction between the two group leaders. The second dimensions cover the content of the program including presentation of the theme, presentation of goals, dimensions of parenting, discussion of the theme, and testing at home. Parents commitment of the method is measured through questionnaires two weeks after each group meeting by questions about the use of program components (yes/no), and how did it work (Positive/Both positive and negative/Negative).
Retaining of family rules as well as positive and negative parenting practices is assessed by Parenting Practices Interview (PPI). In this study the two subscales parental praise and harsh parenting were used and covered by 26 items, rated on a 7-point Likert scale (from never to always, and from not likely at all to extremely likely, depending on the wording of the question).
The General Health Questionnaire-GHQ12 is included to measure the parents mental health, scored on 4-point Likert scale (Positive items - better/more than usual, same as usual, less than usual and much less than usual, Negative items not at all no more than usual, rather more than usual and much more than usual). The 12 items will be divided into a positive scale measuring mental health/well-being and a negative scale measuring mental distress.
The brief version of the Dyadic Adjustment Scale (DAS), covered by the subscale Dyadic Satisfaction is used to measure relational satisfaction/dissatisfaction between parents. Four items on a 7-point Likert scale, ranging from never to always, and extremely unhappy to extremely happy, (dependent on the wording of the question) is used.
Emotion Regulation Questionnaire (ERQ), evaluates the parents' emotion regulation strategies.This is a 10-item self-report questionnaire rated on a 7-point Likert scale (from 1=strongly disagree; 4=Neutral; to 7=strongly agree). Individuals are asked to rate the extent to which they typically try to think or behave differently in situations in order to regulate their own emotions.
In the health economic evaluation, the health variable which will be explored to evaluate cost-effectiveness is health-related quality of life (HRQOL) in children measured by a parent proxy VAS-scale. Additionally, the monetary calculations will use data obtained from contact persons in municipalities/town districts, county council records and national registers.
Previous secondary outcome measures until 08/04/2013:
Program fidelity by group leaders is measured by observations of recorded program sessions. The group leaders are rated according to two dimensions. One regarding competence in terms of framework, speaking with own terms, well prepared, presenting the program in a positive manner, activating parents, strengthening parents and interaction between the two group leaders. The second dimensions cover the content of the program including presentation of the theme, presentation of goals, dimensions of parenting, discussion of the theme, and testing at home. Parents commitment of the method is measured through questionnaires two weeks after each group meeting by questions about the use of program components (yes/no), and how did it work (Positive/Both positive and negative/Negative).
Retaining of family rules as well as positive and negative parenting practices is assessed by Parenting Practices Interview (PPI). In this study the two subscales parental praise and harsh parenting were used and covered by 26 items, rated on a 7-point Likert scale (from never to always, and from not likely at all to extremely likely, depending on the wording of the question).
The General Health Questionnaire-GHQ12 is included to measure the parents mental health, scored on 4-point Likert scale (Positive items - better/more than usual, same as usual, less than usual and much less than usual, Negative items not at all no more than usual, rather more than usual and much more than usual). The 12 items will be divided into a positive scale measuring mental health/well-being and a negative scale measuring mental distress.
The brief version of the Dyadic Adjustment Scale (DAS), covered by the subscale Dyadic Satisfaction is used to measure relational satisfaction/dissatisfaction between parents. Four items on a 7-point Likert scale, ranging from never to always, and extremely unhappy to extremely happy, (dependent on the wording of the question) is used.
Parental emotional regulation is covered by the Affect Regulation Checklist (ARC), rated with12 items on a 7-point Likert scale ranging from 0=do not agree, to 7=completely agree. The ARC includes the two dimensions maladaptive and adaptive strategies.
In the health economic evaluation, the health variable which will be explored to evaluate cost-effectiveness is health-related quality of life (HRQOL) in children measured by a parent proxy VAS-scale. Additionally, the monetary calculations will use data obtained from contact persons in municipalities/town districts, county council records and national registers.
Overall trial start date
09/02/2012
Overall trial end date
20/06/2014
Reason abandoned
Eligibility
Participant inclusion criteria
Family can participate in the trial when the applicant is:
1. A parent or other care giver of a child in the age of 3-12 years
2. Living in one of the participating municipalities in the County of Stockholm or in one of the city districts in the City of Stockholm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600 (300 in intervention group, and 300 in wait-list control group)
Participant exclusion criteria
Family cannot participate in the trial if:
1. The child is having a severe problematic or psychiatric disorder that demands other types of intervention, for example severe depression or a psychiatric diagnosis
2. Parent is in need of intervention or treatment, for example regarding domestic violence, or substance abuse or addiction
Recruitment start date
09/02/2012
Recruitment end date
20/06/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Karolinska Institutet
Stockholm
SE 104 62
Sweden
Sponsor information
Organisation
Swedish National Institute of Public Health (Sweden)
Sponsor details
Forskarens väg 3
Östersund
831 40
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Swedish National Institute of Public Health (Sweden) ref: HFÅ 2010/90
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25326710
Publication citations
-
Results
Ulfsdotter M, Enebrink P, Lindberg L, Effectiveness of a universal health-promoting parenting program: a randomized waitlist-controlled trial of All Children in Focus., BMC Public Health, 2014, 14, 1083, doi: 10.1186/1471-2458-14-1083.