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

NCT05445141 | Active Not Recruiting

• 1 other identifier: VR Dnr: 2021-06447
• Study Type: interventional
• Target: 670
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parental Support; Emotion Regulation; Coping Behavior; Stress, Emotional; Coparenting

Outcome Measures

Primary Outcomes (5)

• 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

  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))

• 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.

  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))

• 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.

  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))

• 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.

  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))

• 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

  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)

• 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.

  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

• Psychological and behavioural problems

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

Study Arms (2)

Intervention

EXPERIMENTAL

Parents 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.

Behavioral: Little ACF [in Swedish: Lilla ABC]

Control

SHAM COMPARATOR

Parents 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.

Behavioral: Lectures

Interventions

Little ACF [in Swedish: Lilla ABC] BEHAVIORAL

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.

Intervention

Lectures BEHAVIORAL

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.

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Parents in need of interpreter will be excluded

Sponsors & Collaborators

• Region Stockholm: collaborator
• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Central Child Health Care (Centrala barnhälsovården)

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36907876 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Stress, Psychological

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Lene Lindberg, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 6, 2022
• Study Start: August 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)