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Parental SupportNCT05445141

Little ACF (Lilla ABC): Evaluation of a Parental Support Program for Parents of Children Aged 1-2 Years

A study testing Little ACF [in Swedish: Lilla ABC] and Lectures in people with Parental Support and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] which has been evaluated for… Read more about this study

Who is it for?
Any age
What is being tested?
Little ACF [in Swedish: Lilla ABC] and Lectures
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
732 participants
Where
1 siteSweden
Study dates
1 Aug 2022to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Parents of children in the age of 1-2 years that are registered at the CHCs included in the study

Who cannot join

  • Parents in need of interpreter will be excluded

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Central Child Health Care (Centrala barnhälsovården)

    Stockholm

Other trials in Sweden

About this study

Official title: Little ACF: A Randomized Controlled Trial on Effects of Universal Parental Group Support Regarding Infants Aged 12-24 Months

Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] which has been evaluated for parents with children aged 3-12 years. The results showed effects on parenting ability, parenting strategies and on children's well-being. Staff in child health care (CHC), a natural arena for parental support programs reaching almost all families, have requested modifications in the program ACF to involve parents with younger children. The parent groups offered within CHC today are not evaluated in younger children and could be thus replaced by researched parental support based on evidence.

The investigators therefore want to study the effects of a modified version of ACF for parents of children 1-2 years (Little ACF) to see if Little ACF can strengthen parenting ability and have effects on children's social and emotional development. Parents within CHC are asked to participate and are randomly assigned to Little ACF or the regular CHC program plus a lecture. Little ACF is offered during four group meetings and potential effects are measured with questionnaires. Measurements are made before randomisation, during and after participation in Little ACF. Children's behavior is followed up at 3 years through questionnaires and CHC documentation.

The study can provide important knowledge about how Little ACF can promote children's mental health and strengthen parents. The investigators see it as a strength that Little ACF is based on research and on dialogue with parents and professionals. Little ACF, which is aimed at everyone, can form a basis for identifying families and children who need preventive and treatment measures.

Read the detailed description

Promotion of mental health is an important topic and early interventions may be the most cost-effective investment for the society. The Child Health Care (CHC) in Sweden reaches 99% of parents with infants and is the society's major promotive support during the first years of life. All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] is a universal program aiming to support positive parental strategies and promote child well-being. ACF has shown positive effects for parental efficacy and strategies and for child well-being at age 3-12 years. In this 3-year project the investigators aim to gain knowledge about how ACF given to parents with children 1-2 years (Little ACF) may influence parenting and child well-being. Specific research questions are how Little ACF in comparison to care as usual (CAU) within CHC can:

  • strengthen strategies of emotional regulation in parents,
  • promote parenting practices,
  • promote child well-being
  • lead to reduction of child behavior problems (externalizing/internalizing),
  • engage and retain parents in groups?

Parents with infants of 12-24 months that are registered at any of the included CHC centers in Stockholm, Gotland and mid-Sweden will be asked for participation. Recruitment will be performed at the ordinary 10-, 12- or 18-months visits of the child. The CHC nurse will ask parent/s for participation verbally and parents will be provided the information and consent form and a pamphlet about the study. Parents who are interested in participating will be sent a link via email with the same information and consent form that can be signed digitally. Thereafter they will be sent the questionnaire. When the CHC nurse has recruited twice as many parents as a full Little ACF group, the researchers will randomize the parents into the two groups, one receiving the intervention Little ACF and the other a control group receiving CAU and digital lectures. The CHC nurse will notify the parents about which group they have been randomized to and a description on how the study will proceed.

A previous randomized study of ACF (aimed at parents with children 3-12 years) showed an effect size (Cohen's d) of 0.30 for parental self-efficacy. Since this study compares Little ACF with CAU including lectures (instead of waiting list), a marginally smaller effect (d = 0.25) between the groups is expected. With a significance level of 95% (p-value 0.05) and a power of 80%, it would thus be needed 251 participants in each group. A drop-out rate of 25% is expected, which means that a total of 670 families would need to be included.

Each Little ACF group will consist of parents of 5-7 children, which means that about 60-70 groups will be needed and thus a total of 25 group leader pairs if each pair leads three groups. The pair of group leaders consist of one CHC nurse and one social worker or other profession with experience of working with parents of young children. Group leaders will be provided a training containing theory, practical exercises, and supervision. The training is spread out over three occasions taking place every other week to allow for the possibility to start Little ACF groups in between the training sessions. After the training, the group leaders will be offered monthly group supervision.

Effects of Little ACF on positive parenting and strategies are assessed through parental questionnaires distributed digitally to be completed independently by the parents. Child well-being is measured through parental questionnaires and data in CHC records. CHC nurses will be invited to semi-structured interviews to gain a better knowledge in how the experience of Little ACF affect daily work at CHC. Quantitative data will be analyzed statistically with linear regression models and qualitative data will be analyzed using thematic analysis.

This study adds to the evidence of promotion during infancy and give information if Little ACF is effective for parents and young children. It may also reduce needs of future interventions of mental health problems.

Being tested
Little ACF [in Swedish: Lilla ABC], Lectures
Medical subject headings
Emotional Regulation, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Little ACF [in Swedish: Lilla ABC]Behavioural

    Little ACF is a modified version of the program called All Children in Focus [in Swedish: Alla Barn i Centrum (ABC)] that originally is developed for parents with children 3-12 years of age. The content is based on positive developmental psychology and involves role plays, discussions and exercises to try at home with the child. Printed material will be provided to the parents at each meeting/session. Little ACF is offered once a week during four weeks. Each session is 60 minutes, thereafter the parents can stay in the facility for 30 minutes to continue discussing with each other.

  • LecturesBehavioural

    The lectures are pre-recorded and available during four weeks. Each lecture is 10 minutes and the content is similar to, but more superficial than, the content in Little ACF.

Study groups in NCT05445141
Study groupRoleWhat they receive
InterventionExperimentalParents included in the intervention group will be offered to participate in four meetings that are taking place during four weeks time. The focus of the meetings is on how to promote parent-infant relationship. The theoretical base is positive developmental psychology including research on attachment, parenting and co-parenting, emotional regulation, and observational learning/role models. Roleplays, video-clips, discussions, and individual reflections are used to empower families during the sessions. Parents are encouraged to try the content with their child between the sessions and will be provided a printed material.
Receives: Behavioral: Little ACF [in Swedish: Lilla ABC]
ControlSham comparatorParents in the control group will via a web-based portal be able to view four pre-recorded lectures during four weeks. The lectures will be around 10 minutes long and have a content similar to the group meetings that are offered to the intervention group but more superficial and without printed material and reflection practices.
Receives: Behavioral: Lectures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in parental self-efficacy from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured with the "Tool to Measure Parenting Self-Efficacy" - TOPSE (Bloomfield \& Kendall, 2012), with 48 statements that are to be answered to on a 11 point scale, from 0=not agree to 10=fully agree

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))

  2. Change in parent emotion regulation from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured with the "Parent Emotion Regulation Scale" - PERS (Pereira et al., 2017). The scale has 20 statements that should be rated on a 5-point scale, from 1=never or almost never to 5=always or almost always.

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))

  3. Change in coping with the negative emotions of the child from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured using "Coping with Toddlers' Negative Emotion Scale" - CTNES (Spinrad et al, 2007), the scale has 12 scenarios with 7 options each on how a parent would react that to that specific scenario (Distress reactions, Punitive reactions, Expressive encouragement, Emotion-focused reactions, Problem-focused reactions, Minimization reactions and Granting wish reactions), the parent are asked to rate how likely s/he is to react in that specific manner from 1 = very unlikely to 7 = very likely, the higher the score the more likely to use that coping mechanism.

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))

  4. Change in parental stress from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured using the scales (1) incompetence, (2) social isolation and (3) role restriction from the "Swedish Parenting Stress Questionnaire" - SPSQ (Östberg, Hagekull \& Wettergren, 1997), the scale is from 1 to 5 indicating 'Strongly disagree' to 'Strongly agree', the total possible score is 170 and higher scores indicate higher stress.

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))

  5. Change in coparenting relationship from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured using 5 items from "The Coparenting Relationship Scale" (Feinberg et al., 2012), to be answered with a 5 point scale from 1=not agree to 5=fully agree

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))

Secondary outcomes (2)

  1. Change in childrens' social and emotional development from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.

    Will be measured using "Ages \& Stages Questionnaires - Socio-Emotional Second Edition" (ASQ: SE-2; Singh et al., 2017)

    Measured: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5), expected effect at T3, T4 and T5

  2. Psychological and behavioural problems

    Strength and Difficulties Questionnaire (SDQ; Theunissen et al., 2013) that is being sent out before the child's visit to CHC at 3 years of age and that is registered in CSAM Health Analytics (medical record system at CHC).

    Measured: In relation to the child's visit to CHC at 3 years of age (T5), expected effect at T5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is a two-armed study including an intervention group and a control group. The groups consist of parents of children 1-2 years that are registered at any of the included CHCs in the study.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05445141
Sponsor's protocol ID
VR Dnr: 2021-06447
Status last verified
Aug 2026
First submitted
27 Jun 2022
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Edenius A, Lindberg L, Ahlen J, Enebrink P, Bergstrom M. Little All Children in Focus (Little ACF) - evaluation of a parenting support programme for parents of children aged 1-2 years in Sweden: a randomised controlled trial. BMC Public Health. 2026 May 19;26(1):1563. doi: 10.1186/s12889-026-27733-2.

    PubMed 42157142

  • Blom L, Edenius A, Enebrink P, Hjern A, Silfverdal SA, Ahlen J, Bergstrom M, Lindberg L. Little All Children in Focus (Little ACF), evaluation of a parental support program for parents of children aged 1-2 years: study protocol for a randomized controlled trial. Trials. 2023 Mar 13;24(1):184. doi: 10.1186/s13063-023-07212-4.

    PubMed 36907876

Questions about this trial

What is this clinical trial studying?

A study testing Little ACF [in Swedish: Lilla ABC] and Lectures in people with Parental Support and Emotion Regulation, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in parental self-efficacy from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old. (time frame: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05445141, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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