The Effect and Experience of the Parental Program AFFEKT

NCT05983705 | Completed

• 4 other identifiers: 2022-01045VGFOUREG-982199VGFOUREG-994156VGFOUREG-1011742
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This project is the first to evaluate the effect and experience of the parent program AFFEKT, through a randomized controlled trial and qualitative study, within primary health care. The project will recruit 200 parents of children with externalizing behaviors, and evaluate the effect of AFFEKT and psychoeducation versus psychoeducation alone, on children's behaviors and mental health, and the parent's strategies and mental health. Through interviews the experience of AFFEKT will be investigated.

Conditions

Behavior, Child; Parenting; Parent-Child Relations; Stress; Quality of Life

Keywords

Randomized Controlled Trial; Qualitative Research; Parents; Child Behavior; Problem Behavior; Multicenter Study; Primary Health Care

Outcome Measures

Primary Outcomes (1)

• Change in disruptive behavior as assessed by the ECBI

  The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Ross, 1978) measures disruptive behavior problems in children through 36 items.

  The ECBI is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.

Secondary Outcomes (6)

• Change in symptoms associated with ADHD as assessed by the SNAP-IV

  The SNAP-IV is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 and +1 year) for both groups.

• Symptoms and social deficits associated with autism spectrum disorders as assessed by the SRS-2

  The SRS-2 is measured at baseline for both groups.

• Change in global stress as assessed by the PSS -14

  The PSS is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.

• Change in general mental ill-health and health as assessed by the GHQ-12

  The GHQ-12 is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups

• Change in quality of life as assessed by the BBQ

  The BBQ is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.

Other Outcomes (2)

• Change in parental self-efficacy and parental satisfaction as assessed by the PSOC

  The PSOC is measured at baseline for both groups, pre AFFEKT (+7 weeks) for the control group, post AFFEKT (+6 weeks) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.

• Change in the child's general health and health behaviors, and change in the parent's general health will be assessed by a questionnaire developed by the researchers

  Measured at baseline, pre AFFEKT (+6 weeks) for the control group, post AFFEKT (+7 weeks ) for the experiment group and (+11 weeks) for the control group, and at follow-up (+6 months and +1 year) for both groups.

Study Arms (2)

Experiment group

EXPERIMENTAL

The experiment group will receive written psychoeducation about children with externalizing behaviors, and start their parental program AFFEKT approximately one week from the information meeting (baseline).

Behavioral: AFFEKT - a manual based brief parent program for parents of children (aged 6-12 years) with externalizing behaviors.

Control group

ACTIVE COMPARATOR

The control group will receive written psychoeducation about children with externalizing behaviors, and start their parental program AFFEKT approximately seven weeks from the information meeting (when the experiment group has finished their AFFEKT program).

Behavioral: AFFEKT - a manual based brief parent program for parents of children (aged 6-12 years) with externalizing behaviors.

Interventions

AFFEKT - a manual based brief parent program for parents of children (aged 6-12 years) with externalizing behaviors. BEHAVIORAL

The AFFEKT program includes five group sessions, two hours each, provided on a weekly basis. The program is delivered by therapist trained in Cognitive and Behavioral Therapy (CBT) and AFFEKT. The participants also receive a participation material, covering the same themes that are addressed in the program and working sheets for the home-assignments that are provided in-between sessions.

Control group; Experiment group

Eligibility Criteria

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

You may qualify if:

• Parent (or primary caregiver) to a child 6-12 years with externalizing issues
• Can communicate in Swedish

You may not qualify if:

• Attending other parental programs
• Non-communicable in Swedish

Sponsors & Collaborators

• Göteborg University: lead
• Medtanken Group AB: collaborator
• FoU i Västra Götalandsregionen: collaborator
• Forte: collaborator

Study Sites (1)

Medtanken Group AB

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Child Behavior; Problem Behavior

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Py Eriksson, Dr

  Gothenburg University, Institute of Psychology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators providing the psychoeducation and collecting the data at the information meeting (baseline) will be blinded since the randomization is carried out after that meeting and by an independent researcher. The individuals conducting the statistical analyses on the data from the RCT study will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial (RCT) and a qualitative study.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 9, 2023
• Study Start: August 23, 2023
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 12 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to the responsible researcher py.eriksson@psy.gu.se

Locations

SE (1)