<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260728070403N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-27</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Motivational Interviewing on Anxiety and Life Satisfaction of Mothers of Children with Mood Disorders</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Motivational Interviewing on Anxiety and Life Satisfaction of Mothers of Children with Mood Disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/92207</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple Randomization
Individual
Using Research Randomizer software (www.randomizer.org)
To conceal allocation, opaque, numbered, and sealed envelopes were used. The envelopes were kept in a separate room in numerical order. After each mother completed the pretest questionnaires, the envelope corresponding to the same number was opened and the individual was assigned to the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depressive disorder: F32.9 (unspecified major depression). Condition 2: F33.9 (اختلال افسردگی عودکننده نامشخص). Condition 3: Bipolar disorder: F31.9 (unspecified bipolar disorder). Condition 4: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Motivational Interviewing (MI) is a participatory, goal-oriented, and empathetic counseling approach designed by Miller and Rollnick (2013) that emphasizes strengthening the individual's intrinsic motivation to change harmful behaviors. This method is implemented in a non-judgmental and supportive environment and in the present study, it is held individually and face-to-face with each mother to help her discover and strengthen her intrinsic motivations to manage anxiety and improve her quality of life. Sessions are held in a private and quiet room in the child psychiatry ward of Ibn Sina Hospital in Mashhad, which is equipped with two comfortable chairs, a small table, and adequate lighting. Required forms, including BAI and Diner questionnaires, and a demographic information form, are provided during the sessions. The intervention consists of 4 40-minute sessions, held once a week for 4 consecutive weeks. The first session, titled Building a Therapeutic Relationship, is dedicated to establishing a trusting relationship, explaining the structure of the sessions, exploring the mother's concerns and challenges, expressing empathy, and identifying strengths and past successes. The second session aims to identify and strengthen internal motivations, explore the mother's values ​​and aspirations, use the importance scale, stimulate a conversation about change with the DARN-C technique (desire, ability, reasons, need, commitment), and strengthen self-efficacy. The third session, focusing on examining barriers to change and resolving oscillations, identifies barriers and ambivalence, uses the two-way review technique, and returns to strong motivations for change. Finally, the fourth session, titled Step-by-Step Planning for Stress Management and Improving Quality of Life, includes brainstorming to find practical solutions, developing a SMART (specific, measurable, attainable, realistic, timed) action plan, and strengthening commitment and final summation. The main techniques used in these sessions include open-ended questions, affirmations and praise, simple and complex reflections of feelings and content, summarization, numerical scales of importance and confidence, and mutual consideration of the pros and cons of change. Between sessions, mothers are asked to do simple home exercises such as a daily record of positive and negative feelings, daily diaphragmatic breathing practice for 5 minutes, and a diary of situations in which they successfully managed their emotions, each taking about 5 to 10 minutes a day. Intervention 2: Control group: The control group will receive standard hospital care during the study period (4 weeks), including routine nursing sessions to follow up on the child's medication status and general education for the mother, monthly general consultation with the ward's psychiatric nurse, access to the treatment team to answer questions, and continuation of the child's medication treatment as recommended by the treating psychiatrist, and will not receive any structured motivational interviewing intervention. In order to observe fairness and ethics in the study, after completing the follow-up phase and collecting all data, a summary of the motivational interviewing training will be provided to the control group in the form of a 60-minute individual or group session (depending on the mothers' preference) so that this group can also benefit from this method.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Some data, such as information on the main outcome, can be shared.

When:
Access begins 6 months after results are published.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Allowed

Where to obtain:
Amir Mohammad Keyvan Shokooh
Mobile: 09155615792
Zip Code: 9177943707
Email: a.keivanshokooh@gmail.com
Mashhad Medical Sciences Campus

How to obtain:
Send email. Accept and send after a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebe pourghaznein</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Blvd</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>١٣٩۴۴٩١٣٨٨</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>PourghazneinT@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>saeed vagheei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vakil Abad Blvd</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>١٣٩۴۴ ٩١٣٨٨</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>vaghees@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mother of a child aged 10-19 with mood disorders
Living with a child with mood disorders
Anxiety score greater than 8 on the BAI
Willingness to participate
No history of mental disorder or psychotropic medication
No substance or alcohol abuse</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Drug and alcohol abuser
Having a history of mental disorder and use of psychotropic</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.9</hc_code>
      <hc_code>F33.9</hc_code>
      <hc_code>F31.9</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, unspecified</hc_keyword>
      <hc_keyword>Major depressive disorder, recurrent, unspecified</hc_keyword>
      <hc_keyword>Bipolar disorder, unspecified</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Motivational Interviewing (MI) is a participatory, goal-oriented, and empathetic counseling approach designed by Miller and Rollnick (2013) that emphasizes strengthening the individual's intrinsic motivation to change harmful behaviors. This method is implemented in a non-judgmental and supportive environment and in the present study, it is held individually and face-to-face with each mother to help her discover and strengthen her intrinsic motivations to manage anxiety and improve her quality of life. Sessions are held in a private and quiet room in the child psychiatry ward of Ibn Sina Hospital in Mashhad, which is equipped with two comfortable chairs, a small table, and adequate lighting. Required forms, including BAI and Diner questionnaires, and a demographic information form, are provided during the sessions. The intervention consists of 4 40-minute sessions, held once a week for 4 consecutive weeks. The first session, titled Building a Therapeutic Relationship, is dedicated to establishing a trusting relationship, explaining the structure of the sessions, exploring the mother's concerns and challenges, expressing empathy, and identifying strengths and past successes. The second session aims to identify and strengthen internal motivations, explore the mother's values ​​and aspirations, use the importance scale, stimulate a conversation about change with the DARN-C technique (desire, ability, reasons, need, commitment), and strengthen self-efficacy. The third session, focusing on examining barriers to change and resolving oscillations, identifies barriers and ambivalence, uses the two-way review technique, and returns to strong motivations for change. Finally, the fourth session, titled Step-by-Step Planning for Stress Management and Improving Quality of Life, includes brainstorming to find practical solutions, developing a SMART (specific, measurable, attainable, realistic, timed) action plan, and strengthening commitment and final summation. The main techniques used in these sessions include open-ended questions, affirmations and praise, simple and complex reflections of feelings and content, summarization, numerical scales of importance and confidence, and mutual consideration of the pros and cons of change. Between sessions, mothers are asked to do simple home exercises such as a daily record of positive and negative feelings, daily diaphragmatic breathing practice for 5 minutes, and a diary of situations in which they successfully managed their emotions, each taking about 5 to 10 minutes a day.</i_keyword>
      <i_keyword>Control group: The control group will receive standard hospital care during the study period (4 weeks), including routine nursing sessions to follow up on the child's medication status and general education for the mother, monthly general consultation with the ward's psychiatric nurse, access to the treatment team to answer questions, and continuation of the child's medication treatment as recommended by the treating psychiatrist, and will not receive any structured motivational interviewing intervention. In order to observe fairness and ethics in the study, after completing the follow-up phase and collecting all data, a summary of the motivational interviewing training will be provided to the control group in the form of a 60-minute individual or group session (depending on the mothers' preference) so that this group can also benefit from this method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: 6 weeks. Method of measurement: Beck Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Satisfaction with life. Timepoint: 6 weeks. Method of measurement: Satisfaction with life scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-10</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Vakil Abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
