Welcome
Support Centre
23 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Evaluation of the ABC – a parental support program
ISRCTN ISRCTN70202532
DOI 10.1186/ISRCTN70202532
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of the ABC – a parental support program
Scientific title Universal parental support program for increasing parental efficacy, children’s mental health and well-being – a randomized controlled trial
Acronym ABC-RCT
Serial number at source N/A
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 parent’s 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 children’s positive development
6. A health economic evaluation of the ABC-program will demonstrate savings and health gains
Lay summary Lay summary under review 1
Ethics approval Regional Review Board at the Karolinska Institutet, 16 February 2012 ref: 2012/93-31/5
Study design Clustered multi centre randomization design
Countries of recruitment Sweden
Disease/condition/study domain Development of child mental and physical health.
Participants - 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
Participants - 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
Anticipated start date 09/02/2012
Anticipated end date 20/06/2014
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet [Swedish]
Target number of participants 600 (300 in intervention group, and 300 in wait-list control group)
Interventions 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.
Primary outcome measure(s) 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 children’s wellbeing are measured by the parent report of KIDSCREEN-52: a questionnaire with 52 items rated on a 5-point Likert scale to measure child’s 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 measure(s) 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. Parent’s 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. Parent’s 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.
Sources of funding Swedish National Institute of Public Health (Sweden) ref: HFÅ 2010/90
Trial website http://www.allabarnicentrum.se
Publications
Contact name Dr  Lene  Lindberg
  Address Karolinska Institutet
Box 17070
  City/town Stockholm
  Zip/Postcode SE 104 62
  Country Sweden
  Email lene.lindberg@ki.se
Sponsor Swedish National Institute of Public Health (Sweden)
  Address Forskarens väg 3
  City/town Östersund
  Zip/Postcode 831 40
  Country Sweden
  Sponsor website: https://www.fhi.se
Date applied 19/10/2012
Last edited 09/05/2013
Date ISRCTN assigned 07/11/2012
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.