Evaluation of the Effectiveness of the "Aidant TLC" Program, Delivered in Person and Remotely, on the Well-being of Informal Caregivers

Population aging is associated with a growing number of individuals experiencing loss of autonomy. Informal caregivers, most often family members or close relatives, play a central role in supporting dependent individuals at home. However, caregiving responsibilities are associated with substantial physical and psychological burden, including stress, emotional distress, and reduced quality of life. Interventions targeting psychosocial skills have shown promise in improving caregiver well-being. Online programs may improve accessibility, although their effectiveness can vary depending on implementation and participant engagement.

The Aidant TLC (Thrive, Learn, Connect) program is a psychosocial and educational intervention designed to enhance emotional regulation, interpersonal skills, and stress management among caregivers. Although developed and evaluated in the United States, this program has not yet been tested in France.

The primary objective of this randomized controlled trial is to compare changes in depressive symptoms and self-efficacy among three groups: (1) participants receiving the TLC intervention remotely, (2) participants receiving the TLC intervention in person, and (3) a control group receiving no intervention. Secondary objectives are to compare changes in caregiver burden, anxiety, perceived benefits of caregiving, empathy, and apathy across the three groups, and to assess adherence to the intervention in remote versus in-person formats.

This study is a three-arm randomized controlled trial including 75 participants (25 per group). Eligible participants are adult informal caregivers (≥18 years) providing at least 4 hours of care per week to a dependent adult, able to understand French, and with access to transportation (in-person group) or internet (remote group).

After baseline assessment (V0), participants will be randomized to one of the three groups using a computerized system. The intervention consists of weekly 2-hour sessions over 6 weeks, delivered either remotely or in person. The control group will not receive the intervention during the study period but will be offered participation after study completion.

Primary outcomes include changes in depressive symptoms (Patient Health Questionnaire-9, PHQ-9) and self-efficacy (General Self-Efficacy Scale, GSE) from baseline to post-intervention (V1). Secondary outcomes include caregiver burden (Zarit Burden Interview-12), anxiety (GAD-7), perceived caregiving benefits (Caregiver Reaction Assessment), empathy (Basic Empathy Scale), and apathy (Apathy Motivation Index). Adherence will be assessed through session attendance, and acceptability will be evaluated via questionnaire in intervention groups.

Data will be analyzed using repeated-measures ANOVA with time (baseline, post-intervention) as a within-subject factor and group (remote, in-person, control) as a between-subject factor. Independent-samples t-tests will be used to compare adherence and acceptability between intervention groups.

The total study duration is 36 months, including 12 months for recruitment, 12 months for intervention delivery, and 12 months for data analysis and dissemination.

If effective, the Aidant TLC program could provide an accessible intervention to improve caregiver well-being, particularly for individuals with limited access to in-person support. No significant risks are anticipated.

• Caregiver burden [Time frame: Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.]
• Anxiety [Time frame: Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.]
• Perceived caregiving benefits [Time frame: Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.]
• Empathy [Time frame: Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.]
• Apathy [Time frame: Assessments will take place at enrollment (T1), within the two weeks prior to the start of the intervention, and at the end of the 6-week intervention period (T2), which will occur no later than 2 weeks after the end of the intervention.]