Implementation and evaluation of a social and emotional learning program for children of parents with substance use disorder

ISRCTN ISRCTN98416613
DOI https://doi.org/10.1186/ISRCTN98416613
Sponsor The Ohio State University
Funder OneOhio Recovery Foundation
Submission date
16/03/2026
Registration date
19/03/2026
Last edited
18/03/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Children that have at least one parent with a substance use disorder (SUD) are at an increased risk of experiencing developmental delays and mental health problems. This study is testing the impact of a social emotional learning (SEL) program on children ages 5 to 11 years old that have a parent(s) with substance use disorder (SUD). We will look at how the program, Emotional ABCs, affects emotional literacy, coping skills, and emotional and behavioral functioning in children that complete the program versus children that do not complete the program. We will also assess the reach, adoption, and implementation of the program. Moreover, the study will examine the costs associated with implementing the Emotional ABCs in existing specialized dockets and substance use treatment programs.

Who can participate?
Children between the ages of 5 years old and 11 years old may participate, along with their adult caregiver. Children must have one parent that is involved in a specialized docket or a treatment program for substance use disorder. All participants must be fluent in English. Caregivers must be able to provide informed consent, and children must be able to provide informed assent. Children are unable to participate if they are already part of a SEL program or if they have certain medical conditions.

What does the study involve?
Participants will be randomly assigned to one of two groups. One group of children will complete the Emotional ABC's program, while the other group will not. All participants will meet with the study team three times over the course of six months. During each of these meetings, caregivers will take a survey (Strengths and Difficulties Questionnaire) while the child completes a series of activities with the study team. The activities explore the children's existing coping skills and ability to identify feelings. A subset of participants in the intervention group will be randomly selected to participate in an interview to explore their views of the program.

What are the possible benefits and risks of participating?
Children that complete the Emotional ABCs program may learn skills to help them cope with stress. The risks for participating in this study are low. Participants may experience stress when completing assessments, but it is expected to be no more than the stress experienced in day-to-day life. Participants may withdraw from the study at any time.

Where is the study run from?
The study is run by a team within the School of Health and Rehabilitation Sciences at The Ohio State University in Columbus, Ohio, United States of America.

When is the study starting and how long is it expected to run for?
The first participant was enrolled in the study in October, 2025. The study will continue recruiting until February, 2027 and all data collection is expected to be complete by August, 2027.

Who is funding the study?
The study is funded by the OneOhio Recovery Foundation (USA)

Who is the main contact?
The main contact is Dr. Lindsay Sullivan, lindsay.sullivan@osumc.edu

Contact information

Dr Lindsay Sullivan
Principal investigator, Scientific, Public

1072B Graves Hall
333 W. 10th Ave.
Columbus
43210
United States of America

ORCiD logoORCID ID 0000-0001-8079-0388
Phone +1 614-366-1963
Email Lindsay.Sullivan@osumc.edu

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentCluster
PurposeTreatment
Scientific titleEnhancing social-emotional well-being in children of parents with substance use disorder
Study objectives 1. Determine the effectiveness of the intervention in improving emotional literacy, coping skills, and emotional and behavioral functioning in children ages 5-11 with a parent with SUD.
2. Evaluate the implementation process and identify factors associated with the uptake, implementation, adaptation, and sustainability of the intervention.
3. Determine the costs of program implementation and maintenance.
Ethics approval(s)

Approved 02/10/2025, Institutional Review Board at The Ohio State University (15 E. 15th Avenue, 4th Floor, Columbus, 43201, United States of America; +1 614-688-8457; BehavioralIRBInfo@osu.edu), ref: 2025B0043

Health condition(s) or problem(s) studiedSocial-emotional well-being in children of parents with substance use disorder
InterventionThe intervention, Emotional ABCs, is a skill based SEL curriculum for children ages 4-11 years old designed to empower children with requisite knowledge and skills to manage their emotions confidently and successfully. The curriculum includes sequential, short videos, and interactive activities as well as offline skill-building activities, games, and rewards that reinforce newly taught skills. The Emotional ABCs curriculum includes 10 units, each with a set of lessons, rewards, and certificates. Children in the intervention group will be instructed to complete all 10 units within 10 weeks. The program caters to learners at different levels of proficiency and was designed in a format that enables children to complete the program with minimal supervision. Prior studies show that completing Emotional ABCs significantly improved children’s social emotional competence compared to those who did not complete the program, with SEL scores three times higher in those who completed the program than those who did not complete the program.

Children will be randomized into the intervention and control group at a 1:1 ratio using a block randomized design stratified by sex to ensure balanced enrollment is achieved throughout the study. Randomization block sizes will be n = 10 (i.e., n = 5/arm). This strategy will help ensure balance on sex and study arm throughout the duration of the trial enrollment. When multiple members of a sibling group are eligible, one sibling per family will be randomly selected to participate in the study.

Children and caregivers in the control group will have no access to the Emotional ABCs online platform. Control children will receive access to the Emotional ABCs program at the end of their study participation.
Intervention typeBehavioural
Primary outcome measure(s)
  1. Emotional literacy measured using Emotional Literacy Checklist at Baseline, Post-intervention, and at 6 months post-intervention (or 3 months and 6 months after baseline for the control group)
Key secondary outcome measure(s)
  1. Coping Skills measured using Draw-and-write technique, Feelings Activity, Problem Solving Vignettes Activity at Baseline, Post-intervention, and at 6 months post-intervention (or 3 months and 6 months after baseline for the control group)
  2. Emotional and Behavioral Functioning measured using Strengths and Difficulties Questionnaire at Baseline, 3 months and 6 months after completing the Emotional ABCs program (or 3 months and 6 months after baseline for the control group)
  3. Dosage measured using Number of certificates of completion intervention children received via the Emotional ABCs online platform at Post-intervention
  4. Engagement & adherence with the Emotional ABCs program measured using Number of program features viewed/accessed, number of units completed, and overall amount of time spent on the Emotional ABCs website during the active intervention period. An overall engagement and adherence score for each participant will be calculated by summing the number of program features viewed/accessed, number of units completed, and the overall amount of time spent engaging with the program. at Active intervention period
  5. Caregiver engagement measured using Duration of time spent engaging in the program with the child in the last week; Frequency of engaging in the program with the child in the last week; Number of program features viewed/accessed in the last week; Details on how they engaged with the program in the last week. at Active intervention period
Completion date31/08/2027

Eligibility

Participant type(s)
Age groupChild
Lower age limit5 Years
Upper age limit11 Years
SexAll
Target sample size at registration100
Key inclusion criteria1. Child aged 5-11 years old at time of study enrollment
2. Child must have a parent enrolled in an Ohio specialized docket or treatment program
3. Child must live with current caregiver for at least one month at the time of study enrollment
4. Adequate proficiency in English
5. Caregiver has a phone that can receive SMS text message
Key exclusion criteria1. Child is enrolled in another social emotional learning (SEL) program
2. Child has a history of severe or profound intellectual disability, cognitive impairment, or psychiatric disorder
Date of first enrolment03/11/2025
Date of final enrolment28/02/2027

Locations

Countries of recruitment

  • United States of America

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

18/03/2026: Trial's existence confirmed by Institutional Review Board at The Ohio State University.