Diabetes type1SWEETNCT05437913
Protocol for Self-Compassion Intervention for Teens With Diabetes Type 1 and Their Caregivers
A study testing Psychological intervention (self-compassion based) in people with Diabetes type1, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Diabetes type1
- What is being tested?
- Psychological intervention (self-compassion based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 6 Sep 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have taken care of the management of the patient with diabetes for at least one year since the day of recruitment
- they have access to a personal mobile phone.
- aged 11-15 years old
- diagnosed with T1D more than 12 months ago at the time of recruitment
- they have access to a personal mobile phone.
- General Exclusion Criteria:
Show all 9Show fewer
- non-Spanish native speakers
- presenting developmental or attention deficit disorders (e.g., autism spectrum disorder, ADHD)
- being diagnosed with a serious mental disorder requiring ongoing treatment (e.g., psychosis) or receiving a pharmacological intervention (e.g., depression, anxiety).
Who cannot join
- untreated hypothyroidism
- recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study
The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.
Read the detailed description
Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.
- Conditions
- Diabetes type1
- Being tested
- Psychological intervention (self-compassion based)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological intervention (self-compassion based)Other
4 weeks intervention for both primary caregivers and adolescents with T1D will be done online through videoconferencing and will be based on three validated protocols that use self-compassion (MSC and MSC Teens).
| Study group | Role | What they receive |
|---|---|---|
| Self compassion intervention | Other | 4 weeks group and online format self compassion intervention Receives: Other: Psychological intervention (self-compassion based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-report psychological variables: depression (caregivers )
- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)
Measured: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
Change in Self-report psychological variables: depression ( teens)
- 2 items for teens: PHQ-2 (Richardson et al., 2010; Spanish version: Arrieta et al., 2017)
Measured: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
Change in Self-report psychological variables: self-compassion (caregivers)
- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation
Measured: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: self-compassion (teens)
- 20 items for teens: SOCS-S (Gu et al., 2020); Spanish version back forward translation and adapted to teens
Measured: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
change in Self-report psychological variables: self-criticism (caregivers)
- 14 items for caregivers: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation
Measured: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: self-criticism (teens)
- 14 items for teens: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation and adapted to teens
Measured: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: self care (caregivers)
- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation
Measured: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: self care (teens)
- 24 items for teens: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation and adapted to teens
Measured: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: interoceptive awareness (caregivers)
- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation
Measured: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report psychological variables: interoceptive awareness (teens)
- 32 items for teens: MAIA-Y (Joenes et al., 2020); Spanish version back forward translation and adapted to teens
Measured: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
Secondary outcomes (22)
change in metabolic outcome 1 (only teens)
glycated hemoglobin (HbA1c)
Measured: Change in HbA1c from pre (Day 1) to post (Day 30). Change in HbA1c from post (Day 30) to follow up3 (Month 3). Change in HbA1c from follow up 3 (month 3) to follow up 6 (month 6).
change in metabolic outcome 2 (only teens)
continuous glucose monitoring (time in range: TiR)
Measured: Change in TiR from pre (Day 1) to post (Day 30). Change in TiR from post (Day 30) to follow up3 (Month 3). Change in TiR from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)
- 14 items: PAID-P (Shapiro et al., 2018); Spanish version back forward translation
Measured: Change in PAID-P from pre (Day 1) to post (Day 30). Change in PAID-P from post (Day 30) to follow up3 (Month 3). Change in PAID-P from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)
- 14 items: PAID-T (Shapiro et al., 2018);Spanish version back forward translation and adapted to teens
Measured: Change in PAID-T from pre (Day 1) to post (Day 30). Change in PAID-T from post (Day 30) to follow up3 (Month 3). Change in PAID-T from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)
- 8 items: DFCS for caregivers, Hood et al., 2007; Spanish version back forward translation
Measured: Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)
- 8 items: DFCS for teens, Hood et al., 2007; Spanish version back forward translation
Measured: Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life
- 10 items: KIDSCREEN-10 (Ravens-Sieberer et al., 2005); Spanish version provided by the same authors
Measured: Change in KIDSCREEN-10 from pre (Day 1) to post (Day 30). Change in KIDSCREEN-10 from post (Day 30) to follow up3 (Month 3). Change in KIDSCREEN-10 from follow up 3 (month 3) to follow up 6 (month 6).
Change in observational behavioural variable (caregiver-teen dyad)
caregiver-adolescent dyadic interaction analysis of neutral and conflictual topic discussion based on Holmbeck et al. (2013) Parent-child interaction macro coding manual (PCIM)
Measured: Change in PCIM between pre (Day 1) and post (Day 30).
Change in ecological momentary assessment: affect (caregivers)
- 1 item: created by the research team measure of affect sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: affect (teens)
- 1 item: created by the research team measure of affect sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment self kindness (caregivers )
- 1 item: created by the research team measure of self kindness sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment self kindness (teens)
- 1 item: created by the research team measure of self kindness sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: self criticism (caregivers)
- 1 item: created by the research team measure of self criticism sent once per day to participants
Measured: baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
Change in ecological momentary assessment: self criticism (teens)
- 1 item: created by the research team measure of self criticism sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: triggering event (caregivers)
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: triggering event (teens)
- 1 item: created by the research team measure of triggering events where the participants are asked to rate how much a potential negative triggering event affected them. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: emotion regulation (caregivers )
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: emotion regulation (teens)
- 1 item: created by the research team measure of emotion regulation strategies where the participants are asked to chose from the list emotion regulation strategies that they used to regulate the emotions related to the triggering event. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) positively. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)
- 1 item: created by the research team measure of positive impact on parent child interaction where the participants are asked to rate how the triggering event impacted their relationship with (caregiver or child) negatively. The item was sent once per day to participants
Measured: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Practice frequency
- 1 item: created by the research team measure of frequency of daily meditation practice
Measured: during the intervention (Day11-Day 30)
Possible adverse effects
6 item scale developped by the team
Measured: Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start6 Sep 2021
- Primary completion15 Mar 2022
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single case multiple randomized baseline design
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Baños Rivera, PhD, Principal investigator, Univeristy of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437913
- Sponsor's protocol ID
- SWEET2021
- Acronym
- SWEET
- Status last verified
- Nov 2021
- First submitted
- 13 Oct 2021
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Self-Compassion Intervention for Adolescents With Diabetes Type 1 and Their Caregivers: Protocol for a Single Case Multiple-baseline Feasibility Study
- ClinicalTrials.gov ID
- NCT05437913
- Acronym / sponsor ID
- SWEET / SWEET2021
- Conditions
- Diabetes type1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine the feasibility and potential effectiveness of a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers on psychological, metabolic, and behavioral outcomes.
Detailed description
Type 1 Diabetes (TD1) has a significant impact on individuals dealing with this chronic metabolic condition, their families and the whole society. A particularly vulnerable group of individuals with TD1 are adolescents. The investigators created a short (4 sessions) self-compassion intervention for adolescents with T1D and their caregivers. Both feasibility and potential clinical effectiveness will be assessed using a single-case, multiple baseline experimental design where psychological, behavioral, and metabolic outcomes will be evaluated at baseline, post intervention, and 3- and 6-months follow ups. Moreover, ecological momentary assessment will be performed daily.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single case multiple randomized baseline design
| Arm | Type | Receives |
|---|---|---|
| Self compassion intervention | Other | Other: Psychological intervention (self-compassion based)4 weeks group and online format self compassion intervention |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- have taken care of the management of the patient with diabetes for at least one year since the day of recruitment
- they have access to a personal mobile phone.
- aged 11-15 years old
- diagnosed with T1D more than 12 months ago at the time of recruitment
- they have access to a personal mobile phone.
Key exclusion criteria (2 listed)
- untreated hypothyroidism
- recently (in previous 48 hours of the recruiting process) diagnosed with (a) diabetic ketoacidosis (DKA) or (b) severe hypoglycaemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological intervention (self-compassion based)4 weeks intervention for both primary caregivers and adolescents with T1D will be done online through videoconferencing and will be based on three validated protocols that use self-compassion (MSC and MSC Teens). | Other | Self compassion intervention |
Primary outcome
Change in Self-report psychological variables: depression (caregivers )
Time frame: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
- 2 items for caregivers: PHQ-2 (Kroenke, 2003; Spanish version: Wulsin et al., 2002)
Change in Self-report psychological variables: depression ( teens)
Time frame: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)
- 2 items for teens: PHQ-2 (Richardson et al., 2010; Spanish version: Arrieta et al., 2017)
Change in Self-report psychological variables: self-compassion (caregivers)
Time frame: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
- 20 items for caregivers: SOCS-S (Gu et al., 2020); Spanish version back forward translation
Change in Self-report psychological variables: self-compassion (teens)
Time frame: Change in SOCS-S from pre (Day 1) to post (Day 30). Change in SOCS-S from post (Day 30) to follow up3 (Month 3). Change in SOCS-S from follow up 3 (month 3) to follow up 6 (month 6).
- 20 items for teens: SOCS-S (Gu et al., 2020); Spanish version back forward translation and adapted to teens
change in Self-report psychological variables: self-criticism (caregivers)
Time frame: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
- 14 items for caregivers: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation
Change in Self-report psychological variables: self-criticism (teens)
Time frame: Change in FSCRS-SR from pre (Day 1) to post (Day 30). Change in FSCRS-SR from post (Day 30) to follow up3 (Month 3). Change in FSCRS-SR from follow up 3 (month 3) to follow up 6 (month 6).
- 14 items for teens: FSCRS-SR (Gilbert, Clarke, Hempel, Miles \& Irons, 2004); Spanish version back forward translation and adapted to teens
Change in Self-report psychological variables: self care (caregivers)
Time frame: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
- 24 items for caregivers: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation
Change in Self-report psychological variables: self care (teens)
Time frame: Change in B-MSC from pre (Day 1) to post (Day 30). Change in B-MSC from post (Day 30) to follow up3 (Month 3). Change in B-MSC from follow up 3 (month 3) to follow up 6 (month 6).
- 24 items for teens: B-MSC (Cook-Cottone, 2018); Spanish version back forward translation and adapted to teens
Change in Self-report psychological variables: interoceptive awareness (caregivers)
Time frame: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
- 32 items for caregivers: MAIA-2 (Mehling et al., 2018); Spanish version back forward translation
Change in Self-report psychological variables: interoceptive awareness (teens)
Time frame: Change in MAIA-2 from pre (Day 1) to post (Day 30). Change in MAIA-2 from post (Day 30) to follow up3 (Month 3). Change in MAIA-2 from follow up 3 (month 3) to follow up 6 (month 6).
- 32 items for teens: MAIA-Y (Joenes et al., 2020); Spanish version back forward translation and adapted to teens
22 secondary outcomes
change in metabolic outcome 1 (only teens)
Time frame: Change in HbA1c from pre (Day 1) to post (Day 30). Change in HbA1c from post (Day 30) to follow up3 (Month 3). Change in HbA1c from follow up 3 (month 3) to follow up 6 (month 6).
change in metabolic outcome 2 (only teens)
Time frame: Change in TiR from pre (Day 1) to post (Day 30). Change in TiR from post (Day 30) to follow up3 (Month 3). Change in TiR from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (caregivers)
Time frame: Change in PAID-P from pre (Day 1) to post (Day 30). Change in PAID-P from post (Day 30) to follow up3 (Month 3). Change in PAID-P from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: diabetes-specific emotional distress (teens)
Time frame: Change in PAID-T from pre (Day 1) to post (Day 30). Change in PAID-T from post (Day 30) to follow up3 (Month 3). Change in PAID-T from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: the diabetes family conflict scale (caregivers)
Time frame: Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: the diabetes family conflict scale (teens)
Time frame: Change in DFCS from pre (Day 1) to post (Day 30). Change in DFCS from post (Day 30) to follow up3 (Month 3). Change in DFCS from follow up 3 (month 3) to follow up 6 (month 6).
Change in Self-report diabetes-related variables: parental report on teen's health-related quality of life
Time frame: Change in KIDSCREEN-10 from pre (Day 1) to post (Day 30). Change in KIDSCREEN-10 from post (Day 30) to follow up3 (Month 3). Change in KIDSCREEN-10 from follow up 3 (month 3) to follow up 6 (month 6).
Change in observational behavioural variable (caregiver-teen dyad)
Time frame: Change in PCIM between pre (Day 1) and post (Day 30).
Change in ecological momentary assessment: affect (caregivers)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: affect (teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment self kindness (caregivers )
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment self kindness (teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: self criticism (caregivers)
Time frame: baseline (Day 1-Day11), post (Day 30-Day 34), follow up3 (Day 90-Day 104), and follow up6 (Day 180- Day194)
Change in ecological momentary assessment: self criticism (teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: triggering event (caregivers)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: triggering event (teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: emotion regulation (caregivers )
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Change in ecological momentary assessment: emotion regulation (teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
change in ecological momentary assessment: positive impact on caregiver-teen interactions (caregivers and teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
change in ecological momentary assessment: negative impact on caregiver-teen interactions (caregivers and teens)
Time frame: Change between baseline (Day 1-Day11) and post (Day 30-Day 34). Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Practice frequency
Time frame: during the intervention (Day11-Day 30)
Possible adverse effects
Time frame: Change between post (Day 30-Day 34) and follow up3 (Day 90-Day 104). Change between follow up3 (Day 90-Day 104) and follow up6 (Day 180- Day194).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Baños Rivera, PhD principal investigator
Univeristy of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological intervention (self-compassion based) in people with Diabetes type1, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-report psychological variables: depression (caregivers ) (time frame: change in PHQ from pre (Day 1) to post (Day 30). Change in PHQ from post (Day30) to Follow up3 (Month 3). Change in PHQ from Follow up 3 (month 3) to Follow up6 (Month 6)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.