Healing Hearts: A Mindfulness App for Parents Navigating Divorce or Separation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Connecticut

About this trial

This study examines online programs for parents navigating divorce or separation. Researchers will study whether a self-guided mindfulness app called Healing Hearts, followed by a self-guided online parenting program called the electronic New Beginnings Program, is feasible and acceptable to parents and shows promising effects on parent and child wellbeing. Ninety-six parents who live in the United States, have a child aged 6 to 18 with a former partner, and report mild to moderate psychological distress will be randomly assigned to one of three groups: Healing Hearts followed by the parenting program, the parenting program alone, or a set of online educational resources. Participants complete online assessments before assignment, about seven weeks later, and about seven weeks after the second assessment. The study measures parent wellbeing, parenting, parent reports of child behavior, program use, and participant experiences. All participation takes place remotely.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years or older.

Able to speak, read, and write in English; living in the United States.

Has a mobile device, internet access on that device, and uses email.

Identifies as a parent and has at least one child aged 6 to 18 years with an ex-partner. Parenting time with the target child exceeds 3 hours/week.

Disqualifiers

Low-speed internet.

Current regular mind-body practices, such as meditation or yoga.

The parent or target child is in psychotherapy or other clinical research.

Kessler 6 score of 0 or 13 or higher.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Healing Hearts

    Behavioral

    Four-Part self-guided web program with daily guided practices, lessons, journal and reflection activities.

  • electronic New Beginnings Program

    Behavioral

    Online parenting skills program containing six modules. Each module takes 30 minutes to complete and contains home practice outside of the program. Prior studies have evaluated the efficacy of this program.

  • Curated internet resources

    Behavioral

    Educational information comparator.

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Healing Hearts and electronic New Beginnings ProgramExperimental treatment 2 interventions
Group B: electronic New Beginnings programActive comparator 1 intervention
Group C: Internet ResourcesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment rate

Number of eligible participants completing baseline assessment divided by months of active recruitment. Will also report the total number of participants randomized.

Time frame
At completion of active recruitment, approximately 12 months after recruitment begins.
2

Retention rate

Percentage of all randomized participants completing the second assessment (T2) within the assessment window. The prior benchmark is at least 80%. The assessment window and completion rule require confirmation.

Time frame
Second assessment (T2), approximately 7 weeks after the baseline assessment.
3

Depressive symptoms

Using the 7-item subscale of the DASS-21 (Depression, Anxiety and Stress Scale - Short Form). Each item is rated on a 0-3 scale (raw score range: 0 - 21). Raw scores are multiplied by 2 to calculate a score that can be interpreted for severity. Higher scores indicate greater depressive symptoms. Depression: Normal 0-9, Mild 10-13, Moderate 14-20, Severe 21-27, Extremely Severe 28+.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).
4

Anxiety symptoms

Using the 7-item subscale of the DASS-21 (Depression, Anxiety and Stress Scale - Short Form). Each item is rated on a 0-3 scale (raw score range: 0 - 21). Raw scores are multiplied by 2 to calculate a score that can be interpreted for severity. Higher scores indicate greater depressive symptoms. Anxiety: Normal 0-7, Mild 8-9, Moderate 10-14, Severe 15-19, Extremely Severe 20+.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).

Secondary outcomes

1

Parental mindful self-regulation

Mindful self-regulation will be measured using the 10-item Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Each item is rated from 1 ("rarely/not at all") to 4 ("almost always"). After reverse-scoring the applicable item, responses are summed to yield a total score from 10 to 40. Higher scores indicate greater dispositional mindfulness, a better outcome.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).
2

Parental executive functioning

Executive functioning will be assessed using the 27-item Executive Function Index (EFI). Items are rated from 1 to 5. After reverse-scoring negatively worded items, responses are summed for a total score ranging from 27 to 135; higher scores indicate better executive functioning.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).
3

Emotion coaching

Using the 14-item Maternal Emotional Style Questionnaire (MESQ). Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Items are summed for a score ranging from 7 to 35. Higher scores indicate greater endorsement of an emotion-coaching parenting style.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).
4

Child prosocial behavior

Using the 5-item Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire (SDQ). Each item is rated on a 3-point scale from 0 (Not True) to 2 (Certainly True). The five items are summed to produce a score ranging from 0 to 10. Higher scores indicate greater prosocial behavior.

Time frame
From baseline to 7 weeks post-baseline (T1 to T2) and from baseline to 14 weeks post-baseline (T1 to T3).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Connecticut

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator