An online self-help program for parents whose partners abuse alcohol

ISRCTN	ISRCTN38702517
DOI	https://doi.org/10.1186/ISRCTN38702517
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Folkhälsomyndigheten 03136-2015
Sponsor	Karolinska Institutet
Funder	Public Health Agency of Sweden

Submission date: 13/11/2017
Registration date: 28/11/2017
Last edited: 17/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Alcohol use disorder (AUD) is a pattern of alcohol use that involves problems controlling your drinking, being preoccupied with alcohol, continuing to use alcohol even when it causes problems, having to drink more to get the same effect, or having withdrawal symptoms when you rapidly decrease or stop drinking. Partners and children of individuals with AUD have impaired quality of life and mental health, but seldom seek or participate in traditional supportive interventions. Engaging the parent/partner without AUD in treatment is a promising way of supporting behavior change in both the child and the parent with AUD. Universal parent training (PT) programs are effective in increasing children's well-being and decreasing problem behaviors, but have yet to be tailored for children with a parent with AUD. Community reinforcement approach and family training (CRAFT) programs are conceptually similar, and aim to promote behavior change in individuals with AUD by having a concerned significant other change environmental contingencies. There have been no studies on whether these two interventions can be combined and tailored for partners of individuals with AUD with common children, and delivered as accessible online self-help. The aim of this study is to find out whether using such an online self-help program leads to reductions in the child's mental health problems, the co-parent’s drinking and the participant's own emotional distress.

Who can participate?
People who share a child showing mental health problems with a co-parent with AUD, but who do not present AUD themselves

What does the study involve?
Participants are randomly allocated to either a four-module online combined PT and CRAFT program, or a psychoeducation-only comparison intervention. The child’s mental health, the partner’s drinking, the participant’s own mental health and drinking, the child’s social adjustment, treatment-seeking, and parental self-efficacy are all assessed before, during and after treatment, and three times during a two-year follow-up period.

What are the possible benefits and risks of participating?
Benefits include help and support in dealing with having a co-parent with AUD, as well as presumed increased mental health. Presumed indirect benefits include increased mental health for the child in common, and reduced drinking in the co-parent with AUD. There are no identified risks with participation.

Where is the study run from?
Stockholm Centre for Dependency Disorders (Sweden)

When is the study starting and how long is it expected to run for?
October 2016 to December 2020 (updated 04/06/2019, previously: December 2019)

Who is funding the study?
Public Health Agency of Sweden

Who is the main contact?
1. Dr Anders Hammarberg
2. Dr Philip Lindner

Contact information

Dr Anders Hammarberg
Scientific

Mottagningen för alkohol och hälsa
Riddargatan 1
Stockholm
11435
Sweden

Dr Philip Lindner
Scientific

Riddargatan 1
Stockhol
11435
Sweden

Study information

Primary study design	Interventional
Study design	Single-centre interventional two-arm randomized controlled superiority trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Combining online community reinforcement and family training with a parent training program for parents with partners suffering from alcohol use disorder: a randomized controlled trial
Study acronym	Skydda barnen
Study objectives	A online combined community reinforcement and parent training self-help program for parents who share a child with a co-parent with alcohol use disorder (AUD) will led to greater reductions in the child's mental health problems, the co-parent's drinking and the participant's own emotional distress.
Ethics approval(s)	Regional Ethics Review Board in Stockholm, 10/02/2017, ref: 2016/2179-31
Health condition(s) or problem(s) studied	Alcohol use disorder; internalizing and externalizing behaviors
Intervention	Participants who share a child showing mental health problems with a person with AUD, but do not present AUD themselves, will be recruited from the general public and randomized 1:1 to: Arm 1: Sequential four-module self-help program integrating psychoeducation and exercises from behavioral parent training and Community Reinforcement And Family Training (CRAFT), with therapist support as needed. Arm 2: Basic psychoeducation about alcohol use disorder (AUD), being a concerned significant other to someone with AUD and having shared children, but no exercises aimed at promoting behavior change. Primary outcome will be the child’s mental health. Additional outcomes will cover the partner’s drinking, the participants own mental health and drinking, the child’s social adjustment, and treatment-seeking in all three parties, and parental self-efficacy. Measures will be collected pre-, mid- and post-treatment, and three times during a two-year follow-up period. Data will be analyzed using mixed effects modeling.
Intervention type	Behavioural
Primary outcome measure(s)	Participant's rating of the child's total score on the Strengths and Difficulties Questionnaire (SDQ) for children, measured at screening (baseline), mid-treatment (completion of 2/4 modules or maximum of 4 weeks into treatment), post-treatment (4/4 modules or maximum of 8 weeks into treatment), 3, 12 and 24 months after completing treatment
Key secondary outcome measure(s)	All outcomes are measured at screening (baseline), mid-treatment (completion of 2/4 modules or maximum of 4 weeks into treatment), post-treatment (4/4 modules or maximum of 8 weeks into treatment), 3, 12 and 24 months after completing treatment: 1. Child's externalizing subscore of the SDQ 2. Child's internalizing subscore of the SDQ 3. Participant's depression subscore on the Depression Anxiety and Stress Scale (DASS) 4. Participant's anxiety subscore on the Depression Anxiety and Stress Scale (DASS) 5. Participant's stress subscore on the Depression Anxiety and Stress Scale (DASS) 6. Participant's alcohol consumption measured using the three-item Alcohol Use Disorder - Identification Test (AUDIT-C) 7. Participant's parental self-efficacy (custom scale) 8. AUD parent's alcohol consumption measured using the AUDIT-C 9. AUD parent's number of ICD-10 alcohol dependence criteria met 10. Participant-child relationship quality measured using the the Adult Child Relationship Scale (ACRS) 11. Help-seeking behavior among the participant, AUD parent, and child
Completion date	31/12/2020

Eligibility

Participant type(s)	Carer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Participant: 18+ years old 2. Participant: sufficient grasp of Swedish 3. Participant's co-parent with AUD: meets AUD criteria, defined as an AUDIT-C score of >3/4 (women/men) and/or meeting >1 ICD-10 dependence criteria 4. Shared child: aged 3-11 5. Shared child: lives >3 days per month with AUD parent 6. Shared child: scores above the clinical cut-off on any of the five sub-scales of the SDQ
Key exclusion criteria	1. Participant: Meets AUD criteria (as defined above) 2. Participant: use of illicit drugs at least one per week during last 12 months 3. Participant: score in the severe range on all three sub-scales of the DASS, or in the extremely severe range on two of the sub-scales 4. Participant: already participates in an intervention aimed at CSOs of individuals with AUD 5. Shared child: has participated in an intervention aimed at children of individuals with AUD in the last 12 months 6. Shared child: has been exposed to family violence in the last 3 months 7. Participant's co-parent with AUD: use of illicit drugs at least one per week during last 12 months
Date of first enrolment	01/12/2017
Date of final enrolment	31/12/2020

Locations

Countries of recruitment

Sweden

Study participating centre

Stockholm Centre for Dependency Disorders

Stockholm
11435
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The de-identified, participant-level data used in the published material will be made available upon request (from date of publication) from the study principal investigator Dr Anders Hammarberg.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		05/09/2022	06/09/2022	Yes	No
Results article		15/02/2023	17/02/2023	Yes	No
Protocol article	protocol	10/08/2018	24/10/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/02/2023: Publication reference added.
06/09/2022: Publication reference added.
24/10/2019: Publication reference added.
04/06/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/12/2018 to 31/12/2020.
2. The plain English summary was updated to reflect this change.
3. The overall end date was changed from 31/12/2019 to 31/12/2020.
4. The intention to publish date was changed from 31/12/2020 to 31/12/2021.