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

April 23, 2026 updated by: Innovation Alzheimer

Évaluation de l'efficacité du Programme " Aidant TLC " en présentiel et à Distance Sur le Bien-être Des Aidants Naturels

As the population ages in France, more people need help with daily activities. Family members and other informal caregivers often provide this support, which can be physically and emotionally demanding and may affect their well-being.

This study evaluates the "Aidant TLC (Thrive, Learn, Connect)" program, a support program designed to help caregivers better manage stress, emotions, and relationships. The program has been developed in the United States but has not yet been tested in France.

The goal of this study is to compare the effects of the program when delivered in two formats: online (remote) and in person. A third group of participants will not receive the program during the study period but will be offered it afterward.

A total of 75 caregivers will take part in the study. Participants will be randomly assigned to one of the three groups. The program consists of weekly group sessions over several weeks. Questionnaires will be used before and after the program to measure mood, stress, confidence, and overall well-being.

The results of this study will help determine whether this program is effective and whether it can be offered more widely to support caregivers, including those who may have difficulty accessing in-person services.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being an informal caregiver of an adult requiring assistance with activities of daily living
  • Providing at least 4 hours of care per week (broadly defined, including direct care as well as help with tasks such as medication management and bill payment)
  • French-speaking
  • Ability to travel (for the in-person intervention) to Nice or Biot (France)
  • Access to the internet at home or in an easily accessible location (for the remote intervention).

Exclusion Criteria:

  • Inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention.
Experimental: In-person group
Psychoeducation group intervention delivered in-person
Behavioral: Psychoeducation
The Aidant TLC program is a 6-session therapeutic education program designed to develop emotional, interpersonal, and stress management skills in informal caregivers. https://caregivertlc.org/
Experimental: Online group
Psychoeducational group intervention delivered online
Behavioral: Psychoeducation
The Aidant TLC program is a 6-session therapeutic education program designed to develop emotional, interpersonal, and stress management skills in informal caregivers. https://caregivertlc.org/

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
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.
Depressive symptoms assessed using the Patient Health Questionnaire (PHQ-9);
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.
Self-efficacy
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.
General Self-Efficacy Scale (GSE)
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Zarit Burden Interview, short version; ZBI-12
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.
Generalized Anxiety Disorder; GAD-7
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.
Caregiver Reaction Assessment; CRA
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.
Basic Empathy Scale; BES
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.
French Apathy Motivation Index - f-AMI
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovation Alzheimer

Collaborators

Universite Cote d'Azur

Investigators

  • Principal Investigator: Valeria Manera, PhD, Université Cote d'Azur
  • Principal Investigator: Philippe Robert, Professor, Innovation Alzheimer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 11, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-A01079-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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